Noninvasive Positive Pressure Ventilation in Moderate Acute Respiratory Distress Syndrome

Acute Respiratory Distress Syndrome Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01585922
• Other study ID #: 20120418BIRM
• Status: Completed
• Phase: N/A
• Start date: July 2012
• Est. completion date: December 2016

Study information

• Verified date: November 2018
• Source: Beijing Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

Procedure:
• noninvasive 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.
• invasive mechanical ventilation
Intubate and give invasive mechanical ventilation to the other group patients when they are allocated at once.

Locations

Country	Name	City	State
China	Beijing Institute of Respiratory Medicine, Beijing Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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