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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