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

This study is currently recruiting participants.
Verified July 2012 by Beijing Hospital
Sponsor:
Information provided by (Responsible Party):
Chen Wang, Beijing Hospital
ClinicalTrials.gov Identifier:
NCT01581229
First received: April 18, 2012
Last updated: July 5, 2012
Last verified: July 2012

April 18, 2012
July 5, 2012
June 2012
June 2013   (final data collection date for primary outcome measure)
  • numbers of patients who met the intubation criteria [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • the numbers of patients who are actually intubated [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01581229 on ClinicalTrials.gov Archive Site
  • inhospital mortalities [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • intensive care unit mortalities [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Early Use of Noninvasive Positive Pressure Ventilation for Intro-pulmonary Acute Lung Injury
Not Provided

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Acute Lung Injury
  • Procedure: noninvasive positive pressure ventilation
    Patients in the NPPV group are ventilated using the CPAP or bilevel positive airways pressure S/T mode.
  • Procedure: oxygen therapy
    In the control group, Venturi masks are used to maintain SpO2 at 92% to 96% by adjusting the oxygen flow rates.
  • Experimental: NPPV
    Intervention: Procedure: noninvasive positive pressure ventilation
  • Active Comparator: Control
    Intervention: Procedure: oxygen therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
Not Provided
June 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Hangyong He, MD 861013693585722 yonghang2004@sina.com
China
 
NCT01581229
2012BAI05B00
No
Chen Wang, Beijing Hospital
Beijing Hospital
Not Provided
Principal Investigator: Chen Wang, MD, PHD Beijing Hospital of the Ministry of Health; Beijing Institute of Respiratory Medicine
Beijing Hospital
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP