Back to resultsEarly Use of Noninvasive Positive Pressure Ventilation for Intro-pulmonary Acute Lung Injury
Primary Purpose
Acute Lung Injury
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
noninvasive positive pressure ventilation
oxygen therapy
Sponsored by
About this trial
This is an interventional supportive care trial for Acute Lung Injury focused on measuring ALI;noninvasive positive pressure ventilation
Eligibility 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.
Sites / Locations
- Beijing Hospital of the Ministry of Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
NPPV
Control
Arm Description
Outcomes
Primary Outcome Measures
numbers of patients who met the intubation criteria
the numbers of patients who are actually intubated
Secondary Outcome Measures
inhospital mortalities
intensive care unit mortalities
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01581229
Brief Title
Early Use of Noninvasive Positive Pressure Ventilation for Intro-pulmonary Acute Lung Injury
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lung Injury
Keywords
ALI;noninvasive positive pressure ventilation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
204 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NPPV
Arm Type
Experimental
Arm Title
Control
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
noninvasive positive pressure ventilation
Intervention Description
Patients in the NPPV group are ventilated using the CPAP or bilevel positive airways pressure S/T mode.
Intervention Type
Procedure
Intervention Name(s)
oxygen therapy
Intervention Description
In the control group, Venturi masks are used to maintain SpO2 at 92% to 96% by adjusting the oxygen flow rates.
Primary Outcome Measure Information:
Title
numbers of patients who met the intubation criteria
Time Frame
1 year
Title
the numbers of patients who are actually intubated
Time Frame
1 year
Secondary Outcome Measure Information:
Title
inhospital mortalities
Time Frame
1 year
Title
intensive care unit mortalities
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chen Wang, MD, PHD
Organizational Affiliation
Beijing Hospital of the Ministry of Health; Beijing Institute of Respiratory Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Hospital of the Ministry of Health
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100020
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
31484582
Citation
He H, Sun B, Liang L, Li Y, Wang H, Wei L, Li G, Guo S, Duan J, Li Y, Zhou Y, Chen Y, Li H, Yang J, Xu X, Song L, Chen J, Bao Y, Chen F, Wang P, Ji L, Zhang Y, Ding Y, Chen L, Wang Y, Yang L, Yang T, Weng H, Li H, Wang D, Tong J, Sun Y, Li R, Jin F, Li C, He B, Sun L, Wang C, Hu M, Yang X, Luo Q, Zhang J, Tan H, Wang C; ENIVA Study Group. A multicenter RCT of noninvasive ventilation in pneumonia-induced early mild acute respiratory distress syndrome. Crit Care. 2019 Sep 4;23(1):300. doi: 10.1186/s13054-019-2575-6.
Results Reference
derived
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Early Use of Noninvasive Positive Pressure Ventilation for Intro-pulmonary Acute Lung Injury
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