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

Acute Lung Injury Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01581229
• Other study ID #: 2012BAI05B00
• Status: Completed
• Phase: N/A
• Start date: June 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Procedure:
• noninvasive positive pressure ventilation
Patients in the NPPV group are ventilated using the CPAP or bilevel positive airways pressure S/T mode.
• oxygen therapy
In the control group, Venturi masks are used to maintain SpO2 at 92% to 96% by adjusting the oxygen flow rates.

Locations

Country	Name	City	State
China	Beijing Hospital of the Ministry of Health	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	numbers of patients who met the intubation criteria		1 year
Primary	the numbers of patients who are actually intubated		1 year
Secondary	inhospital mortalities		1 year
Secondary	intensive care unit mortalities		1 year