Clinical trial NCT01581229: Early Use of Noninvasive Positive Pressure Ventilation for Intro-pulmonary Acute Lung Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Lung Injury
Keywords: ALI;noninvasive positive pressure ventilation
Lead sponsor: Beijing Hospital
Sponsor class: OTHER_GOV
First posted: 2012-04-20
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To assess the safety and efficacy of noninvasive positive pressure ventilation for patients with intro-pulmonary pulmonary acute lung injury and compare this with high-concentration oxygen therapy.


Eligibility criteria: Inclusion Criteria:

1. acute onset;
2. a clinical presentation of respiratory distress;
3. arterial oxygen tension/inspired oxygen fraction (PaO2/FIO2) \< 300 mmHg but \> 200 mmHg while breathing oxygen delivered by a conventional Venturi device at a maximum concentration (50%);
4. presence of bilateral pulmonary infiltrates on posteroanterior chest radiograph;
5. no evidence of left heart failure as assessed by echocardiography and/or a pulmonary artery wedge pressure of \<18 mm Hg.
6. the cause of ALI is consider to be intro-pulmonary.

Exclusion Criteria:

1. age \<18 yrs;
2. Glasgow Coma Scale \< 11;
3. airway or facial injury;
4. pneumothorax or pneumomediastinum;
5. unable to spontaneously clear secretions from the airways;
6. cardiogenic shock or severe hemodynamic instability (systolic blood pressure \<90 mmHg associated with decreased urinary output (\<20 mL.h-1) despite fluid repletion and use of vasoactive agents) of other causes;
7. severe ventricular arrhythmia or unstable myocardial ischemia;
8. severe organ dysfunction (Sequential Organ Failure Assessment score \> 3);
9. end-stage patients who were expected to survive \< 6 months;
10. severe abdominal distension;
11. refusal to receive NPPV;
12. the cause of ALI is consider to be extrapulmonary;
13. unable to cooperate with NPPV application;
14. active upper gastrointestinal bleeding.

Primary outcomes:
measure: numbers of patients who met the intubation criteria
timeFrame: 1 year
measure: the numbers of patients who are actually intubated
timeFrame: 1 year
Secondary outcomes:
measure: inhospital mortalities
timeFrame: 1 year
measure: intensive care unit mortalities
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Hospital of the Ministry of Health
state: Beijing
Study officials:
affiliation: Beijing Hospital of the Ministry of Health; Beijing Institute of Respiratory Medicine
name: Chen Wang, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: He H, Sun B, Liang L, Li Y, Wang H, Wei L, Li G, Guo S, Duan J, Li Y, Zhou Y, Chen Y, Li H, Yang J, Xu X, Song L, Chen J, Bao Y, Chen F, Wang P, Ji L, Zhang Y, Ding Y, Chen L, Wang Y, Yang L, Yang T, Weng H, Li H, Wang D, Tong J, Sun Y, Li R, Jin F, Li C, He B, Sun L, Wang C, Hu M, Yang X, Luo Q, Zhang J, Tan H, Wang C; ENIVA Study Group. A multicenter RCT of noninvasive ventilation in pneumonia-induced early mild acute respiratory distress syndrome. Crit Care. 2019 Sep 4;23(1):300. doi: 10.1186/s13054-019-2575-6.