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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Beijing Hospital.
Recruitment status was  Recruiting
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Lung Injury
Respiratory Distress Syndrome, Adult
Lung Diseases
Respiration Disorders
Respiratory Tract Diseases
Thoracic Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on October 23, 2014