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:
Beijing Hospital
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
- acute onset;
- a clinical presentation of respiratory distress;
- 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%);
- presence of bilateral pulmonary infiltrates on posteroanterior chest radiograph;
- no evidence of left heart failure as assessed by echocardiography and/or a pulmonary artery wedge pressure of <18 mm Hg.
- the cause of ALI is consider to be intro-pulmonary.
Exclusion Criteria:
- age <18 yrs;
- Glasgow Coma Scale < 11;
- airway or facial injury;
- pneumothorax or pneumomediastinum;
- unable to spontaneously clear secretions from the airways;
- 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;
- severe ventricular arrhythmia or unstable myocardial ischemia;
- severe organ dysfunction (Sequential Organ Failure Assessment score > 3);
- end-stage patients who were expected to survive < 6 months;
- severe abdominal distension;
- refusal to receive NPPV;
- the cause of ALI is consider to be extrapulmonary;
- unable to cooperate with NPPV application;
- 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 Lung Diseases |
Respiratory Tract Diseases Respiration Disorders Thoracic Injuries Wounds and Injuries |
ClinicalTrials.gov processed this record on May 21, 2013