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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High PEEP group | Experimental | Patients in high PEEP group will received 10 to 15 cmH2O of PEEP during noninvasive ventilation. |
|
| Low PEEP group | Active Comparator | Patients in low PEEP group will received 5 cmH2O of PEEP during noninvasive ventilation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The level of PEEP during noninvasive ventilation | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 28-day intubation-free survival | from randomization to 28 days after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| 28-day intubation rate | from randomization to 28 days after randomization | |
| the need for intubation within 28 days | The rate of the need for intubation within 28 days after randomization was assessed by two independent reviewers with extensive critical care experience. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mengyi Ma | Contact | 86-023-89012680 | 1062914316@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Chongqing Medical University | Recruiting | Chongqing | China |
These study data contain ethnic demographic information. Since it remains unclear whether Chinese laws permit the public disclosure of such data upon the completion of the research, a decision has been made to temporarily withhold data sharing during the study design phase.
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| ID | Term |
|---|---|
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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|
| from randomization to 28 days after randomization |
| 28-day survival | from randomization to 28 days after randomization |
| 7-category ordinal scale for clinical improvement at 28 days | 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. | from randomization to 28 days after randomization |
| 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 |
| Length of ICU stay | up to 24 weeks |
| 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 |