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Implications of sedation during the use of noninvasive ventilation in children with acute respiratory failure (SEDANIV Study)

Critical Care volume 28, Article number: 235 (2024) Cite this article

Abstract

Background

The objective of this study was to analyze the effects of sedation administration on clinical parameters, comfort status, intubation requirements, and the pediatric intensive care unit (PICU) length of stay (LOS) in children with acute respiratory failure (ARF) receiving noninvasive ventilation (NIV).

Methods

Thirteen PICUs in Spain participated in a prospective, multicenter, observational trial from January to December 2021. Children with ARF under the age of five who were receiving NIV were included. Clinical information and comfort levels were documented at the time of NIV initiation, as well as at 3, 6, 12, 24, and 48 h. The COMFORT-behavior (COMFORT-B) scale was used to assess the patients’ level of comfort. NIV failure was considered to be a requirement for endotracheal intubation.

Results

A total of 457 patients were included, with a median age of 3.3 months (IQR 1.3–16.1). Two hundred and thirteen children (46.6%) received sedation (sedation group); these patients had a higher heart rate, higher COMFORT-B score, and lower SpO2/FiO2 ratio than did those who did not receive sedation (non-sedation group). A significantly greater improvement in the COMFORT-B score at 3, 6, 12, and 24 h, heart rate at 6 and 12 h, and SpO2/FiO2 ratio at 6 h was observed in the sedation group. Overall, the NIV success rate was 95.6%-intubation was required in 6.1% of the sedation group and in 2.9% of the other group (p = 0.092). Multivariate analysis revealed that the PRISM III score at NIV initiation (OR 1.408; 95% CI 1.230–1.611) and respiratory rate at 3 h (OR 1.043; 95% CI 1.009–1.079) were found to be independent predictors of NIV failure. The PICU LOS was correlated with weight, PRISM III score, respiratory rate at 12 h, SpO2 at 3 h, FiO2 at 12 h, NIV failure and NIV duration. Sedation use was not found to be independently related to NIV failure or to the PICU LOS.

Conclusions

Sedation use may be useful in children with ARF treated with NIV, as it seems to improve clinical parameters and comfort status but may not increase the NIV failure rate or PICU LOS, even though sedated children were more severe at technique initiation in the present sample.

Background

Noninvasive ventilation (NIV) is a technique used to support spontaneous breathing. Currently, the best alternative for managing acute respiratory failure (ARF) is invasive mechanical ventilation (IMV), which can cause potential complications. Moreover, its effectiveness in children has been widely demonstrated [1,2,3,4,5,6,7,8]. During the use of NIV, patient adaptation to this kind of respiratory support should be optimal to achieve maximum effectiveness, thus constituting a critical determinant of NIV success [9,10,11].

The administration of sedative drugs is sometimes used to achieve proper patient adaptation to ventilator and can help reduce anxiety, discomfort and improve tolerance to NIV [10, 12,13,14]. However, sedatives produce a decreased level of consciousness, the intensity of which depends on the drug, dose used, and individual variability. They may also cause airway obstruction, hypoventilation, apnea, and cardiac depression [15]. Although sedation is currently commonly used during NIV [3, 6], its indications, usefulness, and safety have not been clearly determined, and there are no published studies that analyze the effects of its administration in children. The main objective of this study was to analyze the evolution of clinical parameters and comfort status during the use of NIV depending on whether sedation was administered or not. As a secondary objective, we aimed to determine whether the use of sedatives is correlated with the need for intubation and length of stay (LOS) in the pediatric intensive care unit (PICU) in children with ARF treated with NIV.

Materials and methods

An observational, prospective, multicenter study was performed, with the initial collaboration of 16 Spanish PICUs. The study period was from January 1st, 2021, to December 31st, 2021. Three PICUs did not complete the protocol or duration of the study, ultimately yielding 13 participating centers (Supplementary material 1).

Children under 5 years of age who were admitted to the PICU, met the clinical criteria for ARF and were treated with NIV for at least 2 h were consecutively included. ARF was defined as the inability of the respiratory system to carry out sufficient gas exchange to meet the metabolic needs of the body, giving rise to ventilation and/or oxygenation disorders [3, 16].

Patients who required intubation within the first 2 h of starting NIV, those on home NIV, postextubation patients, and those who presented any contraindications to starting NIV, such as cardiorespiratory arrest, imminent respiratory exhaustion, hemodynamic instability requiring inotropic support, severe arrhythmias, Glasgow < 9, facial trauma, vocal cord paralysis, undrained pneumothorax, or severe acute respiratory distress syndrome (ARDS) with an SpO2/FiO2 (S/F) ratio (oxygen saturation [SpO2]/fraction of inspired oxygen [FiO2]) less than 150, were excluded [4].

Protocol

NIV was initiated at the discretion of the responsible physician if any of the following conditions were present: ARF without improvement despite medical treatment or another type of respiratory support, progressive dyspnea, hypercapnia with acidosis, or apnea, in the absence of a contraindication for NIV (these were the exclusion criteria).

The choice of NIV interface and modality (continuous positive airway pressure [CPAP] or bilevel positive airway pressure [BLPAP]) was determined by the physician responsible for the patient. Active humidification was used in all the cases. Continuous monitoring was performed via electrocardiography, pulse oximetry, and respiratory rate. Clinical monitoring was also carried out with the Modified Wood Clinical Asthma Scale (mWCAS) [17]. Additionally, blood gas analyses were performed independently of the study.

The patients’ well-being was determined with the COMFORT behavior (COMFORT-B) scale, which includes the “crying” category [18]. The score on this scale ranges from 6 to 30 points (6–10, very comfortable; 11–22, comfortable; and 23–30, not at all comfortable) [19]. Sedation was administered at the discretion of the responsible physician or according to the protocol of each PICU.

Data collection

Physiological data, clinical data, and ventilator parameters were recorded at the time of NIV initiation and again at 3, 6, 12, 24, and 48 h after NIV commenced. The data recorded included heart rate, respiratory rate, SpO2, FiO2, S/F ratio, mWCAS and COMFORT-B score, NIV modality (CPAP or BLPAP), interface, inspiratory positive airway pressure (IPAP), expiratory positive airway pressure (EPAP), pH and pCO2 if arterial, capillary or venous blood gas measurements were available, enteral nutrition and nonpharmacological comfort measures. When calculating the S/F ratio, patients with cyanotic congenital heart disease and SpO2 values > 97% were excluded since the SpO2–PaO2 correlation is lost above this value [20, 21].

If sedation was used, the reason, drug, dose, timing, route and method of administration were recorded, as were any adverse events. Adverse events were considered to be those apparently related to sedation requiring some intervention such as interrupting or decreasing sedation, increasing respiratory support, fluid or vasopressor administration. Potential adverse events included: bradycardia, defined as a heart rate at the lower limit of normal (2nd percentile) for age [22]; hypotension, defined as a systolic blood pressure of less than the 5th percentile derived from normative data for age, sex, and height [23, 24]; respiratory depression or apnea (ineffective respiratory effort, oxygen desaturation).

Data on weight, age, sex, comorbidities, PRISM (Pediatric Risk of Mortality) III score at the start of NIV and at 24 h, etiological diagnosis of ARF, need for intubation, days of stay in the PICU, and mortality were also recorded.

Clinical outcomes

The effect of the administration of sedation on the following outcomes was assessed:

  1. 1.

    Changes in physiological parameters (heart rate, respiratory rate), COMFORT-B score, mWCAS, and the SpO2/ FiO2 ratio at 3, 6, 12, 24, and 48 h. The numerical difference between the values recorded at the specified time points and the initial values was analyzed.

  2. 2.

    NIV failure, which was defined as the need for intubation during the use of the technique according to the physician in charge decision. The suggested failure criteria and possible reason for intubation were: clinical symptoms of severe respiratory distress with signs of imminent respiratory exhaustion, persistent apneas, altered state of consciousness, need for a FiO2 above 0.6 to keep the SpO2 above 90% despite NIV optimization, and hypercapnia with a pH < 7.20.

  3. 3.

    Days of stay in the PICU.

Statistical analyses

Categorical data are expressed as absolute values and percentages. For quantitative data, the mean and standard deviation (SD) were used; otherwise, the median and interquartile range (IQR) were used if the data were not normally distributed. For the analysis of continuous variables, the Mann‒Whitney U test or Student’s t test was used; for categorical variables, Fisher’s exact test or the chi-square test was used, depending on the normality of the distribution of the sample.

To evaluate the effect of sedation on NIV failure, univariate and multivariate logistic regression analyses were performed using the backward stepwise method based on the likelihood ratio (LR). The results are presented as odds ratios (ORs) and 95% confidence intervals (CIs). Receiver operating characteristic (ROC) curves were used to determine cutoff values for the predictive models obtained. The area under the ROC curve (AUC) and the log likelihood (-2LL) were used as measures of predictive ability.

The effect of sedation on the LOS in the PICU was evaluated with univariate Cox proportional hazards regression models and multivariate regression models using the backward stepwise method based on the LR. An event was defined as “PICU discharge”, assessed by the speed at which the event occurred. The results are expressed as hazard ratios (HRs) and corresponding 95% CIs, with an HR < 1 indicating a slower speed and thus a longer stay in the PICU.

To construct the multivariate models, variables with a p value < 0.1 in the univariate analysis and those with clinical relevance described in previous studies as predictors of NIV failure or longer PICU LOS were included [3,4,5, 25]. If there was a risk of collinearity, the earliest variable was selected. A value of p < 0.05 was considered to indicate statistical significance.

Ethical considerations

This study was authorized by the Spanish Agency of Medicines and Medical Devices as an observational postauthorization study (code LBB-MOR-2020-01) and was approved by the Drug Research Ethics Committee of the East Valladolid Health Department (internal code 20-1954) in accordance with the regulations of the Declaration of Helsinki. The Ethics Committee of each participating institution approved the protocol, and the need for informed consent was in line with local regulations.

Results

A total of 457 patients were included during the study period (Fig. 1). The median age was 3.3 months (IQR 1.3–16.1), and the median weight was 5.8 kg (IQR 4–10). The main cause of ARF was acute bronchiolitis (60.8%). The BLPAP modality was used as the first line of treatment in 79% of patients, and the total face mask was the most commonly used interface (82.9%). Table 1 describes the baseline characteristics of the patients according to sedation status.

Fig. 1
figure 1

Flowchart of the study population. NIV, noninvasive ventilation

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Table 1 Demographic and clinical characteristics of the patients at baseline according to sedation status
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Sedative agents

Sedation was used in 213 children (46.6%; 95% CI 41.9–51.3) (sedation group); in 79 (37%) children, it was administered at the beginning of NIV, and 122 of the patients (57.3%) had received some form of sedation 3 h after the start of NIV. Benzodiazepines were the most commonly used drugs (47.9%), followed by alpha-2 agonists (35.7%), as shown in Table 2. Midazolam was the preferred benzodiazepine and was administered intermittently in 15.5% of the children, with a median of 2 intravenous (IV) boluses (IQR 1–3), a median initial dose of 0.1 mg/kg (IQR 0.07–0.1), and a median cumulative dose of 0.16 mg/kg (IQR 0.1–0.3). In 8.9% of the children, it was provided as a continuous IV infusion with a median initial dose of 0.08 mg/kg/h (IQR 0.05–0.1) and a median cumulative dose of 1.73 mg/kg (IQR 1.2–3.3). Dexmedetomidine as a continuous IV infusion was the most commonly used alpha-2 agonist sedative (23.5%), with a median initial dose of 0.5 µg/kg/h (IQR 0.4–0.5) and a median cumulative dose of 16.5 µg/kg (9.2–33.1). Differences per participating center in rate of sedation use, firs-line agent, and route and method of administration are shown in Supplementary material 2.

Table 2 Information on sedation administration in the study population
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Nonpharmacological measures

Nonpharmacological comfort measures were utilized in 309 children (67.6%). These included pacifiers, sucrose, music therapy, holding the patients in caretakers’ arms, or other distraction strategies (such as games or playing on tablets). These measures were used less frequently in the sedation group, albeit with no significant differences in comparison with children who did not receive sedatives (65.7% vs. 70.7%; p = 0.255).

Enteral nutrition

At 12 h, 56.3% of patients had started enteral feeding. Seventy children (15.3%) remained in a fasting state during the first 48 h, 166 (36.3%) tolerated partial enteral nutrition, and 214 (46.8%) achieved full enteral nutrition. At 48 h, patients who were partially or fully fed had better COMFORT-B score [mean 15.1 (SD 3.7) vs. 17.2 (3.5); p = 0.028]. No differences were found in feeding patterns with or without the use of sedation.

Adverse effects

Adverse effects associated with sedation were recorded in 8% of patients: 13 presented with bradycardia without hemodynamic repercussion (11 with dexmedetomidine, 2 with midazolam), and 4 presented with respiratory depression (3 with benzodiazepines and 1 with propofol), requiring a temporary increase in noninvasive respiratory support and interruption or reduction of continuous IV infusion. No intubation seemed to be related to the use of sedation according to the local investigators.

Clinical outcomes

Sedation use and physiological parameters

At NIV initiation, sedation group children had higher PRISM scores (2.2 ± 2.8 vs 1.40 ± 2.3; p = 0.001), more tachycardia (173 ± 24 vs. 165 ± 25; p = 0.014), more distress [COMFORT-B score (23.3 ± 3.8 vs. 20 ± 4.7; p < 0.001)], and more hypoxemia [S/F ratio (231 ± 100.3 vs. 276 ± 95.6; p = 0.002)], showing no statistically significant differences in respiratory rate (55 ± 14.8 vs. 53 ± 14; p = 0.403) and mWCAS (6.4 ± 2.2 vs. 6 ± 2; p = 0.321) (Fig. 2). The five parameters (heart rate, COMFORT-B score, S/F ratio, respiratory rate and mWCAS) showed progressive improvement during NIV treatment in both the sedation and non-sedation groups, although a significantly greater change was observed in the COMFORT-B scale at 3, 6, 12, and 24 h; in the heart rate at 6 and 12 h; in the mWCAS at 3 and 12 h; and in the S/F ratio at 6 h in the group that received sedation (Table 3).

Fig. 2
figure 2

The data were collected at 0, 3, 6, 12, 24 and 48 h after NIV initiation according to sedation status. The mean and 95% confidence intervals are shown. A Heart rate. B Respiratory rate. C Comfort-B scale. (D) SpO2/FiO2 (S/F) ratio. (E) Modified Wood’s clinical asthma score. ªSpO2 over 97% was excluded from the calculation of the S/F ratio. *p < 0.05 for between-group comparisons

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Table 3 Changes of heart rate, respiratory rate, COMFORT-B scale, mWCAS and S/F ratio assessed at different moments during NIV comparing children who received sedatives VS. those who did not. Note that the sample size of non-sedation and sedation groups varies according to the time studied
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Sedation and NIV failure

Twenty-two patients were intubated. In 20 children, NIV failed, and they required intubation during the first 72 h (4.4%, 95% CI 2.4–6.4). The median time to intubation was 23 h (IQR 7.4–46.9). The remaining two children were intubated at 7 and 8 days, respectively, due to a new condition other than the cause of ARF that led to NIV being started; therefore, these cases were not attributed to treatment failure. The reasons for failure were hypoxemia (10), hypercapnia (4), fatigue (3), hemodynamic instability (2), and apnea (1).

Sedative use was more frequent in patients who failed the NIV trial (65% vs. 45.8%; p = 0.092). Univariate analysis of the data revealed that among children who required intubation, those with underlying disease, prematurity and a PRISM III score at NIV initiation were significantly more frequent, while the baseline respiratory rate was greater and the SpO2 was lower (Table 4). Supplementary material 3 offers information on physiological and ventilation parameters, comparing the success and failure groups.

Table 4 Demographic, baseline parameters and sedation status according to the success or failure of NIV. Univariate analyses
Full size table

A multivariate analysis (Supplementary material 4) was performed on the general sample, and the best predictive model for NIV failure was chosen; this model included the PRISM III score at NIV initiation (OR 1.408; 95% CI 1.230–1.611) and the respiratory rate at 3 h (OR 1.043; 95% CI 1.009–1.079), with a predictive capacity of − 2LL = 129.57 and an AUC of 0.807 (95% CI 0.687–0.928, p < 0.001). The optimal cutoff points suggested as predictors of failure were a PRISM III score of 4.2 and a respiratory rate at 3 h of 79 bpm (sensitivity 80% and specificity 81.6%). The use of sedation was not shown to be an independent predictor of NIV failure.

Furthermore, given the known relevance of the S/F ratio as a predictor of NIV failure [4, 21], a second multivariate analysis was performed with a reduced sample of patients (n = 262) to evaluate the effect of sedation adjusted for the S/F ratio. This analysis identified the S/F ratio at 3 h (OR = 0.992; 95% CI = 0.984–0.999) and the PRISM III score at NIV initiation (OR = 1.445; 95% CI = 1.215–1.719) as independent predictors of failure, while sedation was not associated with treatment failure (predictive capacity-2LL = 86.19 and AUC = 0.815; 95% CI = 0.691–0.939, p < 0.001). The suggested optimal S/F ratio cutoff point was 180.5 (sensitivity 73.3% and specificity 72%) (Supplementary material 3).

Sedation and length of PICU stay

The PICU LOS was significantly greater in patients who received sedation (5 days, IQR 3–8 vs. 4 days, IQR 3–6; p = 0.019). Cox regression analysis was used to determine the factors associated with a longer PICU stay (hazard ratio [HR] < 1): weight (HR 1.072, 95% CI 1.041–1.103), PRISM III score at 24 h (HR 0.859, 95% CI 0.803–0.920), respiratory rate at 12 h (HR 1.017, 95% CI 1.006–1.027), SpO2 at 3 h (HR 1.069, 95% CI 1.023–1.117), FiO2 at 12 h (HR 0.031, 95% CI 0.004–0.219), NIV failure (HR 0.275, 95% CI 0.130–0.580), and hours of NIV (HR 0.995, 95% CI 0.993–0.997). According to the adjusted model, sedation was not related to a longer PICU stay (Supplementary material 4).

Five patients died (1.1%), but none of these deaths were attributable to the use of NIV or sedatives.

Discussion

The present study suggests that sedation can contribute to improving the physiological parameters and comfort status of children younger than 5 years with ARF during the use of NIV without promoting NIV failure or prolonging their PICU stay. To our knowledge, this is the first study focused on assessing the effects of sedation in children with ARF during NIV.

The prevalence of sedation practices during the use of NIV is highly variable. Pediatric studies that have recorded this information are limited and include a wide range of sedation use, ranging from 12 to 78% [2, 4, 5, 21]. In our cohort, almost half of the patients received sedatives, preferably intermittently, during the first hours of NIV, the two most common of which were midazolam and dexmedetomidine. The findings of the only international survey on sedation practices during the use of NIV, directed at adult patients, showed that benzodiazepines were the most commonly used drugs (33%), with only 5% of physicians using dexmedetomidine [26]. However, these data, published a few years ago, may not accurately represent current sedation practices, as more recent publications reveal an increase in the use of dexmedetomidine [27,28,29,30], probably due to its anxiolytic, sedative and analgesic effects without affecting the respiratory pattern, although they may cause bradycardia and hypotension [29,30,31,32]. In our study, 11 patients developed bradycardia secondary to the use of dexmedetomidine, although none of the patients required intervention or interruption of the drug infusion. In contrast, IV benzodiazepines were the main agents responsible for respiratory depression events, suggesting that alternative approaches should be considered.

On the other hand, we observed that nonpharmacological measures to control discomfort were used by only two-thirds of the patients, and there was no relationship between the use of sedation and the use of these interventions. Milési et al. [33] suggested in a recent guideline for the management of bronchiolitis in the PICU that nonpharmacological strategies should be undertaken before administering sedatives, which seems to be a sensible approach.

The different behaviors of several clinical markers in children who received sedatives compared to those who did not should be highlighted; we observed that heart rate, the mWCAS, and the S/F ratio improved significantly more in the sedation group. Similarly, regarding the COMFORT-B scale scores, we also observed a significantly greater decrease in the number of children who received sedatives; after 6 h, the comfort scores were similar in both the sedation and non-sedation groups. These findings suggest that sedation may be helpful for tolerating NIV and could improve the success of an NIV trial. In terms of comfort and tolerability of this respiratory support, it has been reported a significant improvement with the use of neural triggering during NIV (NIV NAVA). It should be indicated that no patients receiving NIV NAVA were included in the present study [34].

In the present sample, less than 5% of patients were intubated, with a NIV success rate of 95.6%, which is higher than that reported in previous pediatric studies, where this rate ranged between 64 and 85% [2,3,4,5, 7, 21, 25]. Notably, in our study, 9 children who required intubation during the first 2 h of NIV were excluded; we concluded that due to the inherent severity of their condition and the short duration, it would not be possible to assess the effects of sedation and establish a causal link with treatment failure. Even considering the early failure of these patients, our success rate is much greater than that reported in the literature (93.8%). The availability of pediatric interfaces designed specifically for infants [35] and the greater experience acquired by physicians in NIV management, including rigorous patient selection, are factors that could have contributed to improving the success rate of NIV. Nonetheless, it cannot be ruled out a potential influence of an earlier institution of the technique in a less severe condition due to the current familiarity with NIV.

Notably, according to the baseline data (lower S/F ratio and higher heart rate and PRISM III score at NIV initiation), the sedation group seemed to have a significantly more severe condition than did the non-sedation group. This finding may agree with the hypothesis put forward by Leboucher et al., who stated that patients in the most severe condition are the most uncomfortable or that at least they are perceived as such [9]. However, multivariate analysis did not include the use of sedatives in the predictive model for the need for intubation, demonstrating that only the PRISM III score at NIV initiation and respiratory rate at 3 h were included in the final model. Interestingly, when the S/F ratio was included in the multivariate analysis, the S/F ratio at 3 h and PRISM III score at NIV initiation were the only factors independently linked to NIV failure. All these variables had already been identified as independent predictors of NIV failure in previous studies [3, 21, 25], even though PRISM III had not been calculated at NIV initiation before.

The PICU LOS was greater in children who received sedation than in those who did not, but these findings were not confirmed with the adjusted analysis. Muriel et al. observed a longer ICU stay in adults on NIV who received sedatives, although the authors did not perform multivariate analyses to support their findings [10]. Many factors may influence the length of stay in the PICU, especially the need for IMV and severity status [7, 8, 36], as also demonstrated by our results.

Among the limitations of the study, we highlight that the observational, noninterventional design, without a drug dosing protocol, made it difficult to assess the effects of each particular sedative. It is necessary to carry out randomized clinical trials to evaluate the effectiveness of each drug during NIV. Similarly, the effect of different non-pharmacological strategies could not be assessed. Also, the aforementioned low intubation rate compels us to interpret the present results cautiously. Lastly, the lack of a systematic evaluation of blood gases in all patients at the beginning of and during NIV limited the analysis of acidosis and hypercapnia as possible predictors of failure.

This study has several strengths. First, SEDANIV is the only multicenter study published to date that offers data on the management of patients receiving NIV; this topic has not yet been explored in children. Second, these results reflect the daily clinical practice of PICUs at different levels of care in Spain, so the results could be extrapolated to other centers with similar protocols and materials. Third, the prospective design, which included a large cohort of children, allowed us to evaluate a series of physiological parameters and clinical scales collected at regular intervals and in real time during the use of NIV.

Conclusions

In agitated children less than five years of age under NIV, use of sedatives seems to be beneficial in terms of improving clinical markers and tolerance of the technique. Despite being more tachypneic and more hypoxemic and having a higher PRISM III score at NIV initiation, children who received sedatives had a significantly greater degree of comfort than did those who were not sedated, reaching similar COMFORT-B scale scores at the six-hour mark. Furthermore, heart rate, the S/F ratio, and the mWCAS improved significantly more in the treated group than in non-sedation group, without this being associated with greater NIV failure or a longer stay in the PICU. Further studies should focus on the ideal drugs, route of administration and dosing during NIV in children.

Availability of data and materials

The datasets used and analyzed during the current study are available from the corresponding author upon reasonable request.

Abbreviations

ARF:

Acute respiratory failure

AUC:

Area under the ROC curve

BLPAP:

Bilevel positive airway pressure

CPAP:

Continuous positive airway pressure

EPAP:

Expiratory positive airway pressure

HR:

Hazard ratio

IMV:

Invasive mechanical ventilation

IPAP:

Inspiratory-positive airway pressure

IQR:

Interquartile range

LOS:

Length of stay

mWCAS:

Modified Wood Clinical Asthma Scale

NIV:

Noninvasive ventilation

OR:

Odds ratio

PICU:

Pediatric Intensive Care Unit

PRISM:

Pediatric Risk of Mortality

ROC:

Receiver operating characteristic

SD:

Standard deviation

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Acknowledgements

We would like to thank all members of the SEDANIV Study group of the Spanish Society of Pediatric Intensive Care, who should be considered coauthors of the manuscript. The members of the SEDANIV Study group are Martí Pons-Ódena (Hospital Sant Joan de Déu), Marta Brezmes Raposo, María Asunción Pino Vázquez and Lorena Bermúdez-Barrezueta (Hospital Clínico Universitario de Valladolid); Ana Vivanco-Allende and Juan Mayordomo-Colunga (Hospital Universitario Central de Asturias); María Miñambres-Rodríguez and Susana Beatriz Reyes-Domínguez (Hospital Clínico Universitario Virgen de la Arrixaca); Yolanda López Fernández and Zaloa Gorostizaga (Hospital Universitario de Cruces); Alba Palacios Cuesta and Lidia Oviedo Melgares (Hospital Universitario Doce de Octubre); Juan Valencia Ramos and Maite Cuervas-Mons Tejedor (Complejo Asistencial Universitario de Burgos), José Luis Unzueta-Roch and María Ángeles García Teresa (Hospital Infantil Universitario Niño Jesús), Mikel Mendizábal Diez and María Teresa Rives Ferreiro (Hospital Universitario de Navarra), Jorge López González and Sarah N. Fernández-Lafever (Hospital General Universitario Gregorio Marañón), Lourdes Artacho González and José Manuel González-Gómez (Hospital Regional Universitario de Málaga), María Teresa Jiménez Villalta and Raúl Montero-Yéboles (Hospital Universitario Reina Sofía), Ainhoa Jiménez Olmos (Hospital Universitario Miguel Servet), Vicente Modesto I Alapont (Hospital Universitario y Politécnico La Fe), Antonio Rodríguez-Núñez (Complejo Hospitalario Universitario de Santiago), Soraya Gutiérrez-Marqués and Aida González-Benavides (Hospital Universitario de León), Sira Fernández de Miguel and Elcira González-Salas (Hospital Universitario de Salamanca). The authors would like to thank Sergio Madero-Juez for the design of the figures and Vicente Modesto I Alapont for his collaboration in the statistical analysis.

Funding

No funding was received for this manuscript.

Author information

Author notes

  1. Lorena Bermúdez-Barrezueta and Juan Mayordomo-Colunga contributed equally as first co-authors.

Authors and Affiliations

  1. Pediatric and Neonatal Intensive Care, Department of Pediatrics, Hospital Clínico Universitario de Valladolid, Av. Ramón y Cajal, 3, 47003, Valladolid, Spain

    Lorena Bermúdez-Barrezueta

  2. Department of Pediatrics, Faculty of Medicine, Valladolid University, Valladolid, Spain

    Lorena Bermúdez-Barrezueta

  3. Pediatric Intensive Care Unit, Hospital Universitario Central de Asturias, Oviedo, Spain

    Juan Mayordomo-Colunga & Ana Vivanco-Allende

  4. Department of Pediatrics, University of Oviedo, Oviedo, Spain

    Juan Mayordomo-Colunga

  5. Centro de Investigación Biomédica en Red Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III, Madrid, Spain

    Juan Mayordomo-Colunga

  6. Primary Care Interventions to Prevent Maternal and Child Chronic Diseases of Perinatal and Developmental Origin (RICORS), Instituto de Salud Carlos III, RD21/0012/0020, Madrid, Spain

    Juan Mayordomo-Colunga

  7. Pediatric Intensive Care Unit, Department of Pediatrics, Hospital Universitario Virgen de la Arrixaca, Murcia, Spain

    María Miñambres-Rodríguez & Susana Reyes

  8. Pediatric Intensive Care Unit, Department of Pediatrics, Complejo Asistencial Universitario de Burgos, Burgos, Spain

    Juan Valencia-Ramos & Maite Cuervas-Mons Tejedor

  9. Ciencias de la Salud, University of Burgos, Burgos, Spain

    Juan Valencia-Ramos

  10. Pediatric Intensive Care Unit, Department of Pediatrics, Hospital Universitario de Cruces, BioBizkaia-Bizkaia Health Research Institute, Bizkaia, Spain

    Yolanda Margarita Lopez-Fernandez

  11. Pediatric Intensive Care Unit, Department of Pediatrics, Hospital Universitario de Navarra, Pamplona, Spain

    Mikel Mendizábal-Diez

  12. Instituto de Investigación Sanitaria del Principado de Asturias, Oviedo, Spain

    Juan Mayordomo-Colunga & Ana Vivanco-Allende

  13. Pediatric Intensive Care Unit, Department of Pediatrics, Hospital Universitario, 12 de Octubre, Madrid, Spain

    Alba Palacios-Cuesta & Lidia Oviedo-Melgares

  14. Pediatric Intensive Care Unit, Department of Pediatrics, Hospital Infantil Universitario Niño Jesús, Madrid, Spain

    José Luis Unzueta-Roch

  15. Pediatric Intensive Care Unit Department, Hospital General Universitario Gregorio Marañón, Madrid, Spain

    Jorge López-González

  16. Pediatric Intensive Care Unit, Department of Pediatrics, Hospital Universitario Reina Sofía, Córdoba, Spain

    María Teresa Jiménez-Villalta

  17. Pediatric Intensive Care Unit, Department of Pediatrics, Hospital Regional Universitario de Málaga, Málaga, Spain

    Lourdes Artacho González

  18. Pediatric Intensive Care Unit, Department of Pediatrics, Hospital Universitario Miguel Servet, Zaragoza, Spain

    Ainhoa Jiménez Olmos

  19. Inmune and Respiratory Dysfunction Research Group, Institut de Recerca Sant Joan de Déu, Santa Rosa 39-57, 08950, Esplugues de Llobregat, Spain

    Martí Pons-Òdena

  20. Pediatric Intensive Care and Intermediate Care Department, Hospital Universitario Sant Joan de Déu, Universitat de Barcelona, Esplugues de Llobregat, Spain

    Martí Pons-Òdena

Authors
  1. Lorena Bermúdez-Barrezueta
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  2. Juan Mayordomo-Colunga
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  3. María Miñambres-Rodríguez
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  4. Susana Reyes
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  5. Juan Valencia-Ramos
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  6. Yolanda Margarita Lopez-Fernandez
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  7. Mikel Mendizábal-Diez
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  8. Ana Vivanco-Allende
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  9. Alba Palacios-Cuesta
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  10. Lidia Oviedo-Melgares
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  11. José Luis Unzueta-Roch
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  12. Jorge López-González
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  13. María Teresa Jiménez-Villalta
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  14. Maite Cuervas-Mons Tejedor
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  15. Lourdes Artacho González
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  16. Ainhoa Jiménez Olmos
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  17. Martí Pons-Òdena
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Consortia

SEDANIV Study group of the Spanish Society of Pediatric Intensive Care

  • Martí Pons-Òdena
  • , Marta Brezmes Raposo
  • , María Asunción Pino Vázquez
  • , Lorena Bermúdez-Barrezueta
  • , Ana Vivanco-Allende
  • , Juan Mayordomo-Colunga
  • , María Miñambres-Rodríguez
  • , Susana Beatriz Reyes-Domínguez
  • , Yolanda López Fernández
  • , Zaloa Gorostizaga
  • , Alba Palacios-Cuesta
  • , Lidia Oviedo-Melgares
  • , Juan Valencia-Ramos
  • , Maite Cuervas-Mons Tejedor
  • , José Luis Unzueta-Roch
  • , María Ángeles García Teresa
  • , Mikel Mendizábal-Diez
  • , María Teresa Rives Ferreiro
  • , Jorge López-González
  • , Sarah N. Fernández-Lafever
  • , Lourdes Artacho González
  • , José Manuel González-Gómez
  • , María Teresa Jiménez-Villalta
  • , Raúl Montero-Yéboles
  • , Ainhoa Jiménez Olmos
  • , Vicente Modesto i Alapont
  • , Antonio Rodríguez-Núñez
  • , Soraya Gutiérrez-Marqués
  • , Aida González-Benavides
  • , Sira Fernández de Miguel
  •  & Elcira González-Salas

Contributions

LBB, MPO, JMC and MMR contributed to the study conception and design and participated in protocol development, study management, and data interpretation. MPO developed the database. LBB and MPO supervised the study. LBB and VMA participated in the statistical analysis. LBB drafted the initial manuscript. JMC contributed to the drafting and editing of the final manuscript. LBB, JMC, MPO, MMR, SR, JVR, YMLF, MM, AVA, APC, LOM, JLUR, JL, MTJV, MCMT, LAG and AJH performed critical revision of the manuscript. The members of the SEDANIV Study Group participated in the data collection. All the authors read and approved the final manuscript.

Corresponding author

Correspondence to Lorena Bermúdez-Barrezueta.

Ethics declarations

Ethics approval and consent to participate

The study was approved by the Drug Research Ethics Committee of the East Valladolid Health Department (internal code 20-1954). The Ethics Committee of each participating institution approved the protocol, and the need for informed consent was in line with local regulations.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

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Bermúdez-Barrezueta, L., Mayordomo-Colunga, J., Miñambres-Rodríguez, M. et al. Implications of sedation during the use of noninvasive ventilation in children with acute respiratory failure (SEDANIV Study). Crit Care 28, 235 (2024). https://doi.org/10.1186/s13054-024-04976-2

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Keywords

Critical Care

ISSN: 1364-8535