Noninvasive Positive Pressure Ventilation in Moderate Acute Respiratory Distress Syndrome

Study Overview
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Brief Summary
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In order to identify the effect of noninvasive positive pressure ventilation (NPPV) on decreasing inflammatory response, improving the pathophysiological manifestation and reducing the morbidity and mortality in the moderate acute respiratory distress syndrome (ARDS) patients, the investigators conduct this clinical trial comparing NPPV with invasive mechanical ventilation in more than twenty ICUs in China.

Conditions
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Acute Respiratory Distress Syndrome

Intervention / Treatment
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* Procedure: noninvasive positive pressure ventilation (NPPV)
* Procedure: invasive mechanical ventilation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: acute onset a clinical presentation of respiratory distress arterial oxygen tension/inspired oxygen fraction (PaO2/FiO2) between 200 mmHg to 300 mmHg. The arterial oxygen tension will be measured in fifteen minutes after NPPV (CPAP 5 cmH2O) was used to the patients stably presence of bilateral pulmonary infiltrate on chest radiograph no evidence of left heart failure as assessed by echocardiography and/or a pulmonary artery wedge pressure( PAWP) < 18 mmHg Exclusion Criteria: age > 70 years or < 18 years PaCO2 > 50mmHg Glasgow Coma Scale (GCS)< 11 Upper airway/facial deformity or injury pneumothorax or pneumomediastinum unable to spontaneously clear secretions from their airway respiratory arrest severe ventricular arrhythmia or active myocardial ischemia severe organ dysfunction (including gastrointestinal hemorrhage, disseminated intravascular coagulation, hepatic and renal dysfunction, SOFA score > 1) severe chronic lung diseases(COPD, Asthma or ILD, et al) end-stage patients who are expected to survive less than six months severe abdominal distension refuse to receive NPPV unable to cooperate with NPPV

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NPPV<br>Use the NPPV to treat moderate ARDS | Procedure: noninvasive positive pressure ventilation (NPPV)<br>* Use NPPV to treat the ARDS patients,and we choose the NPPV ventilators in which the FiO2 can be fixed, for example: the BiPAP Vision or V60 of Phillip Respironics.<br>|
| Active Comparator: IMV<br>Use invasive mechanical ventilation in treating the patients allocated to this group. | Procedure: invasive mechanical ventilation<br>* Intubate and give invasive mechanical ventilation to the other group patients when they are allocated at once.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all cause mortality |  | From the date of randomization to the date of discharge from ICU and hospital, or to the date of death of all cause, an expected average of 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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noninvasive positive pressure ventilation