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
  Purpose

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.


Condition Intervention
Acute Lung Injury
Procedure: noninvasive positive pressure ventilation
Procedure: oxygen therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care

Resource links provided by NLM:


Further study details as provided by Beijing Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • inhospital mortalities [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • intensive care unit mortalities [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: June 2012
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NPPV Procedure: noninvasive positive pressure ventilation
Patients in the NPPV group are ventilated using the CPAP or bilevel positive airways pressure S/T mode.
Active Comparator: Control Procedure: oxygen therapy
In the control group, Venturi masks are used to maintain SpO2 at 92% to 96% by adjusting the oxygen flow rates.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01581229

Contacts
Contact: Hangyong He, MD 861013693585722 yonghang2004@sina.com

Locations
China, Beijing
Beijing Hospital of the Ministry of Health Recruiting
Beijing, Beijing, China, 100020
Contact: Yanming Li, MD         
Sub-Investigator: Yanming Li, MD         
Sponsors and Collaborators
Beijing Hospital
Investigators
Principal Investigator: Chen Wang, MD, PHD Beijing Hospital of the Ministry of Health; Beijing Institute of Respiratory Medicine
  More Information

No publications provided

Responsible Party: Chen Wang, vice president, Beijing Hospital
ClinicalTrials.gov Identifier: NCT01581229     History of Changes
Other Study ID Numbers: 2012BAI05B00
Study First Received: April 18, 2012
Last Updated: July 5, 2012
Health Authority: China: Ministry of Science and Technology

Keywords provided by Beijing Hospital:
ALI;noninvasive positive pressure ventilation

Additional relevant MeSH terms:
Acute Lung Injury
Respiratory Distress Syndrome, Adult
Lung Injury
Wounds and Injuries
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Thoracic Injuries

ClinicalTrials.gov processed this record on April 17, 2014