Acute Respiratory Distress Syndrome
Conditions
Keywords
noninvasive positive pressure ventilation
Brief summary
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.
Interventions
PROCEDUREnoninvasive positive pressure ventilation (NPPV)
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.
PROCEDUREinvasive mechanical ventilation
Intubate and give invasive mechanical ventilation to the other group patients when they are allocated at once.
Sponsors
Beijing Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. acute onset 2. a clinical presentation of respiratory distress 3. 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 4. presence of bilateral pulmonary infiltrate on chest radiograph 5. no evidence of left heart failure as assessed by echocardiography and/or a pulmonary artery wedge pressure( PAWP) \< 18 mmHg
Exclusion criteria
1. age \> 70 years or \< 18 years 2. PaCO2 \> 50mmHg 3. Glasgow Coma Scale (GCS)\< 11 4. Upper airway/facial deformity or injury 5. pneumothorax or pneumomediastinum 6. unable to spontaneously clear secretions from their airway 7. respiratory arrest 8. severe ventricular arrhythmia or active myocardial ischemia 9. severe organ dysfunction (including gastrointestinal hemorrhage, disseminated intravascular coagulation, hepatic and renal dysfunction, SOFA score \> 1) 10. severe chronic lung diseases(COPD, Asthma or ILD, et al) 11. end-stage patients who are expected to survive less than six months 12. severe abdominal distension 13. refuse to receive NPPV 14. unable to cooperate with NPPV
Design outcomes
Primary
| Measure | 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 |
Countries
China
Outcome results
None listed