Noninvasive Positive Pressure Ventilation in Moderate Acute Respiratory Distress Syndrome

Beijing Hospital

Status: Completed

Conditions: Acute Respiratory Distress Syndrome

Treatments: Procedure: invasive mechanical ventilation; Procedure: noninvasive positive pressure ventilation (NPPV)

Study type: Interventional

Funder types: Other

Identifiers

NCT01585922

20120418BIRM

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

NPPV

Experimental group

Description:

Use the NPPV to treat moderate ARDS

Treatment:

Procedure: noninvasive positive pressure ventilation (NPPV)

IMV

Active Comparator group

Description:

Use invasive mechanical ventilation in treating the patients allocated to this group.

Treatment:

Procedure: invasive mechanical ventilation