Early Use of Noninvasive Positive Pressure Ventilation for Intro-pulmonary Acute Lung Injury

NCT ID: NCT01581229

Last Updated: 2018-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 204 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2016-12-31

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.

Conditions

Acute Lung Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

NPPV

Group Type: EXPERIMENTAL

noninvasive positive pressure ventilation

Intervention Type: PROCEDURE

Patients in the NPPV group are ventilated using the CPAP or bilevel positive airways pressure S/T mode.

Control

Group Type: ACTIVE_COMPARATOR

oxygen therapy

Intervention Type: PROCEDURE

In the control group, Venturi masks are used to maintain SpO2 at 92% to 96% by adjusting the oxygen flow rates.

Interventions

noninvasive positive pressure ventilation

Patients in the NPPV group are ventilated using the CPAP or bilevel positive airways pressure S/T mode.

Intervention Type: PROCEDURE

oxygen therapy

In the control group, Venturi masks are used to maintain SpO2 at 92% to 96% by adjusting the oxygen flow rates.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Chen Wang

vice president

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chen Wang, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

Beijing Hospital of the Ministry of Health; Beijing Institute of Respiratory Medicine

Locations

Beijing Hospital of the Ministry of Health

Beijing, Beijing Municipality, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 31484582 (View on PubMed)

Other Identifiers

2012BAI05B00

Identifier Type: -

Identifier Source: org_study_id