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Table 1 Characteristics of the randomized control trials included in qualitative synthesis

From: Effects of early extubation followed by noninvasive ventilation versus standard extubation on the duration of invasive mechanical ventilation in hypoxemic non-hypercapnic patients: a systematic review and individual patient data meta-analysis of randomized controlled trials

Study Setting Primary endpoint Secondary endpoints Number of patients included in the original paper Baseline characteristics of patients at entry into the study Number of excluded patients and reasons Number of patients potentially to be analyzed Number of patients analyzed
Ferrer et al. 2003 2 Spanish hospitals The decrease of the duration of invasive ventilation defined as positive pressure ventilation delivered through orotracheal intubation or tracheotomy, in the NIV group. 1. Total period of ventilatory support
2. ICU length of stay
3. Hospital length of stay
4. Reintubation
5. Main causes of reintubation
 - Severe persistent hypoxemia
 - Severe dyspnoea
 - Inability to manage secretions
 - Hemodynamic instability
6. Tracheotomy
7. ICU survival
8. Causes of death within 90d after entry in the study
 - Septic shock/MOF
 - Refractory hypoxemia
 - Cardiac arrest
 - Pneumothorax
 - Stroke
 - Pulmonary embolism
43 patients
21 NIV
22 Control
1. Age
2. Sex
3. Current or former smoker
4. Current of former alcohol abuse
5. APACHE II
6. Duration of ICU stay
7. Duration of mechanical ventilation
8. Number of comorbidities per patient
9. White blood cells
10. Haematocrit
11. Patients with chronic pulmonary disorders
12. Causes of mechanical ventilation
 - Exacerbation of chronic pulmonary disorders
 - Congestive heart failure
 - Community-acquired pneumonia
 - Hospital-acquired pneumonia
 - Postoperative respiratory failure
 - Acute lung injury
 - Thoracic trauma
 - Haemoptysis
 - Cardiac arrest
17 acute-on-chronic exacerbation COPD
9 acute cardiogenic pulmonary oedema
3 severe asthma
8 chronic pulmonary disorder
6 patients
4 Intervention
2 Control
6 patients
4 Intervention
2 Control
Trevisan et al. 2008 Single-centre Brazil To evaluate the use of bi-level NIV for patients who fail weaning from i-MV 1. ICU length of stay
2. Hospital length of stay
3. otal length of stay in hospital
4. ICU death
5. Ward death
6. Mechanical ventilation time after randomization
7. Total mechanical ventilation time
8. Complications
 - Pneumonia
 - Sepsis
 - Congestive heart failure
 - Tracheotomy
 - Return to IMV
 - Skin necrosis
65 patients
28 NIV
37 Control
1. Age
2. Sex
3. APACHE-II
4. Duration of mechanical ventilation
5. Causes of mechanical ventilation
 - COPD aggravation and asthma
 - Heart diseases
 - Respiratory diseases
 - Post-surgery respiratory failure
 - Acute pulmonary lesion
 - Pneumonia
 - Tuberculosis
 - Thoracic trauma
23 acute-on-chronic exacerbation COPD and asthma
11 acute cardiogenic pulmonary oedema
5 PaCO2 >50 mmHg and pH >7.35
2 age <18 years old
24 patients
10 Intervention
14 Control
24 patients
10 Intervention
14 Control
Vaschetto et al. 2012 Single-centre Italy Duration of i-MV 1. ICU length of stay
2. ICU mortality
3. Hospital mortality
4. Extubation failure
5. i-MV before T0
6. i-MV AFTER T0
7. 28-i-MV free days
8. 28-MV free days
9. Weaning
10. Side effects/complications of i-MV
Tracheotomy
Continuous i.v. sedation
20 patients
10 NIV
10 Control
1. Age
2. Sex
3. APACHE II
4. Causes of mechanical ventilation
 - Pancreatitis
 - Pneumonia
 - Thoracic trauma
 - Bowel obstruction
None 20 patients
10 Intervention
10 Control
20 patients
10 Intervention
10 Control
Carron et al. 2014 Single-centre Italy Weaning success/failure rate 1. Duration of i-MV
2. Duration of ventilator support for weaning
3. Duration of total ventilator support
4. Weaning failure
5. Reintubation
 - Refractory hypoxemia
 - Bronchial hypersecretion
 - Transient ischemic attack
 - Hypercapnia
6. Conventional weaning after reintubation with/without percutaneous dilatational tracheostomy
7. Main complication after entry in the study
 - VAP
 - Catheter-related pneumonia
 - Septic shock
 - Multiple-organ Failure
 - Disseminated intravascular coagulation
 - Cardiogenic shock
 - Cardiac arrest
8. ICU length of stay
9. Hospital length of stay
10. ICU survival
11. Hospital survival
64 patients
32 NIV
32 Control
1. Age
2. Sex
3. Weight
4. APACHE II
5. ARF hypoxemic hypercapnic (n. of patients)
 - Exacerbation of chronic pulmonary disease
 - Asthma
 - Community-acquired bronchopneumonia
 - Hospital acquired-bronchopneumonia
6. ARF hypoxemic (n. of patients)
 - Postoperative respiratory failure
 - Community-acquired bronchopneumonia
 - Hospital acquired-bronchopneumonia
 - Acute cardiogenic pulmonary oedema
 - Congestive heart failure
 - Acute pulmonary embolism
 - Acute pancreatitis
 - Acute lung injury following ab ingestis
 - Thoracic trauma
 - Burn
17 acute-on-chronic exacerbation COPD
1 Asthma
5 acute cardiogenic pulmonary oedema
4 BMI ≥30
10 PaCO2 >50 mmHg and Ph >7.35
27 patients
14 Intervention
13 Control
27 patients
14 Intervention
13 Control
Perkins et al. 2018 41 hospitals UK Time from randomization to successful liberation from all forms of mechanical ventilation 1. Mortality at 30, 90, 180 days
2. Duration of i-MV
3. Duration of total ventilation
4. Time to meeting ICU discharge
criteria (defines as no further requirement for level 2/3 care)
5. Reintubation rates
6. Tracheostomy
7. Adverse events and serious adverse events
364 patients
182 NIV
182 Control
1. Age
2. Sex
3. Evidence of delirium
4. Body mass index
5. Duration of ventilation prior to randomization
6. Antibiotics for respiratory
7. Infections
8. APACHE II
9. Admission diagnosis
 - Pneumonia/respiratory infection
 - Post-surgery respiratory failure
 - Cardiac
 - Non-respiratory infection
 - Neuromuscular
 - COPD/asthma exacerbation
 - Traumatic injuries
 - GIT bleeding
 - Pancreatitis
 - Stroke
15 neuromuscular patients
14 COPD/asthma exacerbation
33 acute cardiogenic pulmonary oedema
48 PaCO2 >50 mmHg and pH >7.35
254 patients
130 Intervention
124 Control
254 patients
130 Intervention
124 Control
Vaschetto et al. 2019 6 hospitals
China
3 hospitals Italy
1. Days of i-MV
 - Overall
 - Medical
 - Surgical
2. ICU length of stay
 - Overall
 - Medical
 - Surgical
1. Treatment failure
2. Severe events
3. Tracheostomy
4. VAT
5. VAP
6. Use of sedatives
7. Hospital length of stay
8. ICU mortality
9. Hospital mortality
130 patients
65 NIV
65 Control
1. Main causes of i-MV
 - ARDS
 - Pneumonia
 - Septic shock
 - Polytrauma
 - Postoperative abdominal surgery
 - Postoperative vascular surgery
 - Postoperative thoracic surgery
 - GIT bleeding
 - Cerebral bleeding
 - Pancreatitis
2. Days of i-MV pre-protocol
3. Days of NIV pre-protocol
2 PaCO2 >50 mmHg and pH >7.35 128 patients
65 Intervention
63 Control
128 patients
65 Intervention
63 Control
  1. APACHE II Acute Physiology and Chronic Health Disease Classification System II, ARDS Acute Respiratory Distress Syndrome, ARF Acute Respiratory Failure, BMI Body Mass Index, COPD Chronic Obstructive Pulmonary Disease, GIT Gastrointestinal, ICU Intensive Care Unit, i-MV invasive Mechanical Ventilation, i.v. intravenous, LOS Length Of Stay, MOF Multiple Organ Failure, N.A. Not Applicable, NIV Non-Invasive Ventilation, PaCO2 arterial partial pressure of carbon dioxide, PE Pulmonary Embolism, UK United Kingdom, VAP Ventilator Associated Pneumonia, VAT Ventilator Associated Tracheobronchitis