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Table 2 Efficacy and safety outcomes at 28 days in patients included in the primary (intention-to-treat) analysis, grouped according to study intervention (n = 243)

From: Early prolonged prone position in noninvasively ventilated patients with SARS-CoV-2-related moderate-to-severe hypoxemic respiratory failure: clinical outcomes and mechanisms for treatment response in the PRO-NIV study

Outcome

Controls

(n = 162)

Prone position

(n = 81)

Absolute or mean difference (95% CI)

HR

(95% CI )

p

Primary outcome

     

NIV failure at 28 days

70 (43%)

14 (17%)

− 26% (− 17%, − 41%)

0.32 (0.21, 0.50)

< 0.001

Secondary outcomes

     

Death at 28 days

59 (36%)

10 (12%)

− 24% (− 15%, − 39%)

0.27 (0.17, 0.44)

< 0.001

ETI at 28 daysa

44 (30%)

8 (11%)

− 19% (− 13%, − 33%)

0.31 (0.18–0.55)

0.001

Length of stay in subintensive care unit (d)

7 (5, 9)

6 (5, 8)

− 1 (− 2, 0)

 

0.047

Days of invasive mechanical ventilation (d)

8 (2, 14)

6 (2, 12)

− 1 (− 2, 2)

 

0.618

Death in invasively ventilated mechanically ventilated patients

27 (64%)

2 (25%)

− 39% (− 20% to − 85%)

0.39 (0.24–0.67)

0.034

Length of hospital stay (d):

     

 Whole study population

16 (12, 20)

15 (10, 20)

0 (− 1, 0)

 

0.156

 Hospital survivors

19 (15, 22)

15 (10, 20)

− 3 (− 5, − 1)

 

0.040

Discharged from hospital n (%)

101 (62%)

70 (86%)

  

< 0.001

Daily hours of NIV

20.3 (15.9, 22.2)

20.1 (18.2, 22.4)

− 1 (0, − 1)

 

0.738

Total days of NIV at 28 days

7 (5, 9)

6 (5, 8)

− 1 (− 2, 0)

 

0.047

Daily hours of PP

–

12.2 (10.1, 13.8)

− 

  

Duration of the longest PP session each day

–

10.9 (9.1, 13.3)

–

  

Number of PP sessions each day

–

2 (1, 3)

–

  

Total days of PP therapy at 28 days

–

6 (5, 8)

–

  

Safety endpoints

     

Back pain

14 (9%)

10 (12%)

  

0.512

Intravenous/arterial line dislodgement

10 (6%)

5 (6%)

  

0.825

Hemodinamic instability

0 (0%)

0 (0%)

  

0.999

Barotraumab

4 (3%)

4 (4%)

  

0.831

Pneumothorax/

1 (1%)

0 (0%)

   

Pneumomediastinum

4 (3%)

4 (5%)

   

Subcutaneous emphysema

3 (2%)

3 (4%)

   

Gastric distension and vomiting

0 (0%)

0 (0%)

  

0.999

Device-related: nasal skin ulceration

3 (2%)

2 (2%)

  

0.816

Facial edema

5 (3%)

6 (7%)

  

0.513

Thoraco-abdominal wall hematoma

2 (1%)

3 (3%)

  

0.639

Venous thrombosis

    

0.315

 Upper limb

5 (3%)

4 (5%)

   

 Lower limb

0

0

   

Subintensive Care Unit-acquired Infection

12 (7%)

8 (10%)

  

0.332

Excessive sedationc

1 (1%)

1 (1%)

  

0.911

Acute kidney injury requiring renal replacement therapy

1 (1%)

1 (1%)

  

0.974

Liver failure

0 (0%)

0 (0%)

  

0.999

Need for emergency ETI

0 (0%)

0 (0%)

  

0.999

Time to NIV failure (d)

5 (3, 9)

9 (5, 13)

  

0.031

Time to death (d)

8 (6, 11)

14 (10, 16)

  

0.013

Time to ETI (d)a

5 (2, 8)

9 (4, 10)

  

0.044

Reason for ETIa,b

     

Worsening or non-improving hypoxemia

44 (32%)

8 (11%)

  

0.001

Respiratory muscle fatigue

22 (16%)

6 (9%)

  

0.209

Worsening or unbearable dyspnea

40 (29%)

4 (6%)

  

< 0.001

Intolerance to treatment

4 (3%)

3 (4%)

  

0.316

Altered mental status

1 (1%)

0 (0%)

  

0.741

Shock

0 (0%)

0 (0%)

  

0.999

Hypercapnia

1 (1%)

0 (0%)

  

0.741

Inability to clear secretions

1 (1%)

0 (0%)

  

0.741

Extracorporeal membrane oxygenation

1 (1%)

0 (0%)

  

0.639

  1. ETI, endotracheal intubation; NIV, noninvasive ventilation
  2. aAmong patients with a full treatment indication (n = 208)
  3. bSubcategories are not mutually exclusive and may not necessarily sum to the category total
  4. cDefined by a RASS < − 3 for more than 30 min
  5. Statistically significant differences are written in bold character
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Critical Care

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