Acute Lung InjuryNCT01581229
Early Use of Noninvasive Positive Pressure Ventilation for Intro-pulmonary Acute Lung Injury
A study testing noninvasive positive pressure ventilation and oxygen therapy in people with Acute Lung Injury, run by Beijing Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Lung Injury
- What is being tested?
- noninvasive positive pressure ventilation and oxygen therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteChina
- Study dates
- Jun 2012to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Hospital of the Ministry of Health
Beijing, Beijing Municipality, 100020
About this study
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.
- Conditions
- Acute Lung Injury
- Being tested
- noninvasive positive pressure ventilation, oxygen therapy
- Keywords
- ALI;noninvasive positive pressure ventilation
- Medical subject headings
- Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
noninvasive positive pressure ventilationProcedure or surgery
Patients in the NPPV group are ventilated using the CPAP or bilevel positive airways pressure S/T mode.
oxygen therapyProcedure or surgery
In the control group, Venturi masks are used to maintain SpO2 at 92% to 96% by adjusting the oxygen flow rates.
| Study group | Role | What they receive |
|---|---|---|
| NPPV | Experimental | Not described Receives: Procedure: noninvasive positive pressure ventilation |
| Control | Active comparator | Not described Receives: Procedure: oxygen therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
numbers of patients who met the intubation criteria
Measured: 1 year
the numbers of patients who are actually intubated
Measured: 1 year
Secondary outcomes (2)
inhospital mortalities
Measured: 1 year
intensive care unit mortalities
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2012 (estimated)
- Study startJun 2012
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Lung InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Chen Wang, Beijing Hospital
- Investigators
- Chen Wang, MD, PHD, Principal investigator, Beijing Hospital of the Ministry of Health; Beijing Institute of Respiratory Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01581229
- Sponsor's protocol ID
- 2012BAI05B00
- Status last verified
- Nov 2018
- First submitted
- 18 Apr 2012
- Last updated
- 21 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31484582
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Use of Noninvasive Positive Pressure Ventilation for Intro-pulmonary Acute Lung Injury
- ClinicalTrials.gov ID
- NCT01581229
- Acronym / sponsor ID
- 2012BAI05B00
- Conditions
- Acute Lung Injury
- Keywords
- ALI;noninvasive positive pressure ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Beijing HospitalOther government
- Study start
- Jun 2012
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 20 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NPPV | Experimental | Procedure: noninvasive positive pressure ventilation |
| Control | Active comparator | Procedure: oxygen therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (14 listed)
- age <18 yrs;
- Glasgow Coma Scale < 11;
- airway or facial injury;
- pneumothorax or pneumomediastinum;
- unable to spontaneously clear secretions from the airways;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| noninvasive positive pressure ventilationPatients in the NPPV group are ventilated using the CPAP or bilevel positive airways pressure S/T mode. | Procedure or surgery | NPPV |
| oxygen therapyIn the control group, Venturi masks are used to maintain SpO2 at 92% to 96% by adjusting the oxygen flow rates. | Procedure or surgery | Control |
Primary outcome
numbers of patients who met the intubation criteria
Time frame: 1 year
the numbers of patients who are actually intubated
Time frame: 1 year
2 secondary outcomes
inhospital mortalities
Time frame: 1 year
intensive care unit mortalities
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2018.
- Derived from this study: PubMed 31484582He 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chen Wang, MD, PHD principal investigator
Beijing Hospital of the Ministry of Health; Beijing Institute of Respiratory Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing noninvasive positive pressure ventilation and oxygen therapy in people with Acute Lung Injury, run by Beijing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
numbers of patients who met the intubation criteria (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01581229, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2018.