ARDS, Noninvasive Ventilation, Pneumonia
Conditions
Brief summary
Noninvasive ventilation is commonly employed in patients with pneumonia or acute respiratory distress syndrome (ARDS) and has been shown to reduce the need for intubation and invasive mechanical ventilation. However, the rate of noninvasive ventilation failure remains substantial, at approximately 40%. Compared with patients in whom noninvasive ventilation succeeds, those who experience noninvasive ventilation failure have a higher likelihood of mortality during their intensive care unit or hospital stay. Therefore, improving the success rate of noninvasive ventilation is clinically important. In patients with lung consolidation receiving invasive mechanical ventilation, high positive end-expiratory pressure (PEEP) can improve oxygenation. Noninvasive ventilation operates on similar physiological principles and can also deliver high PEEP via a mask interface. Nevertheless, there is limited evidence regarding the use of high PEEP during mask-delivered noninvasive ventilation. This study aimed to evaluate whether high PEEP can increase intubation-free survival in patients with pneumonia or ARDS who are treated with noninvasive ventilation.
Interventions
PROCEDUREThe level of PEEP during noninvasive ventilation
In patients receiving noninvasive ventilation, participants will be randomly assigned to either a low or a high PEEP group. In the high PEEP group, PEEP will be set between 10 and 15 cmH2O. In the low PEEP group, PEEP will be maintained at 5 cmH2O.
Sponsors
Chongqing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>18 years * PaO2/FiO2 ≤300 mmHg or SpO2/FiO2 ≤315（SpO2 ≤97%) * Anticipated NIV duration \> 12 h * Preserved consciousness (GCS≥13)
Exclusion criteria
* Use of NIV \> 24 h before randomization * Acute-on-chronic respiratory failure * Congestive heart failure * Use of NIV after extubation (within 48 hours) * Contraindications to NIV (e.g., anatomical malformations, recent pulmonary/esophageal surgery \[within 7 days\]) * Pneumothorax * NIV intolerance * Refusal to participate * Pregnancy * Need for emergency intubation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 28-day intubation-free survival | from randomization to 28 days after randomization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the need for intubation within 28 days | from randomization to 28 days after randomization | The rate of the need for intubation within 28 days after randomization was assessed by two independent reviewers with extensive critical care experience. |
| 28-day survival | from randomization to 28 days after randomization | — |
| 7-category ordinal scale for clinical improvement at 28 days | from randomization to 28 days after randomization | The 7-category ordinal scale is as follows: 1 = not hospitalized and has resumed normal activities; 2 = not hospitalized but unable to resume normal activities; 3 = hospitalized without requiring supplemental oxygen; 4 = hospitalized and requiring supplemental oxygen; 5 = hospitalized and requiring HFNC, NIV, or both; 6 = hospitalized and requiring extracorporeal membrane oxygenation (ECMO), invasive mechanical ventilation, or both; 7 = death. |
| 28-day invasive ventilator-free days | from randomization to 28 days after randomization | — |
| 28-day noninvasive ventilator days | from randomization to 28 days after randomization | — |
| 28-day intubation rate | from randomization to 28 days after randomization | — |
| Length of hospital stay | up to 24 weeks | — |
| ICU mortality | up to 24 weeks | — |
| Hospital mortality | up to 24 weeks | — |
| 60-day mortality | from randomization to 60 days after randomization | — |
| Length of ICU stay | up to 24 weeks | — |
Countries
China
Contacts
Primary ContactMengyi Ma
Outcome results
None listed