Acute Respiratory Distress SyndromeNCT01585922
Noninvasive Positive Pressure Ventilation in Moderate Acute Respiratory Distress Syndrome
A study testing noninvasive positive pressure ventilation (NPPV) and invasive mechanical ventilation in people with Acute Respiratory Distress Syndrome, run by Beijing Hospital at 1 site in China.
Trial summary
In order to identify the effect of noninvasive positive pressure ventilation (NPPV) on decreasing inflammatory response, improving the pathophysiological manifestation and reducing the morbidity and mortality in the moderate acute respiratory distress syndrome (ARDS) patients, the investigators conduct this clinical… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- What is being tested?
- noninvasive positive pressure ventilation (NPPV) and invasive mechanical ventilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Jul 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 to 70 years
- 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) between 200 mmHg to 300 mmHg. The arterial oxygen tension will be measured in fifteen minutes after NPPV (CPAP 5 cmH2O) was used to the patients stably
- presence of bilateral pulmonary infiltrate on chest radiograph
- no evidence of left heart failure as assessed by echocardiography and/or a pulmonary artery wedge pressure( PAWP) < 18 mmHg
Who cannot join
- age > 70 years or < 18 years
- PaCO2 > 50mmHg
- Glasgow Coma Scale (GCS)< 11
- Upper airway/facial deformity or injury
- pneumothorax or pneumomediastinum
- unable to spontaneously clear secretions from their airway
Show all 14Show fewer
- respiratory arrest
- severe ventricular arrhythmia or active myocardial ischemia
- severe organ dysfunction (including gastrointestinal hemorrhage, disseminated intravascular coagulation, hepatic and renal dysfunction, SOFA score > 1)
- severe chronic lung diseases(COPD, Asthma or ILD, et al)
- end-stage patients who are expected to survive less than six months
- severe abdominal distension
- refuse to receive NPPV
- unable to cooperate with NPPV
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Institute of Respiratory Medicine, Beijing Hospital
Beijing, Beijing Municipality, 100020
About this study
In order to identify the effect of noninvasive positive pressure ventilation (NPPV) on decreasing inflammatory response, improving the pathophysiological manifestation and reducing the morbidity and mortality in the moderate acute respiratory distress syndrome (ARDS) patients, the investigators conduct this clinical trial comparing NPPV with invasive mechanical ventilation in more than twenty ICUs in China.
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- noninvasive positive pressure ventilation (NPPV), invasive mechanical ventilation
- Keywords
- noninvasive positive pressure ventilation
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
noninvasive positive pressure ventilation (NPPV)Procedure or surgery
Use NPPV to treat the ARDS patients,and we choose the NPPV ventilators in which the FiO2 can be fixed, for example: the BiPAP Vision or V60 of Phillip Respironics.
invasive mechanical ventilationProcedure or surgery
Intubate and give invasive mechanical ventilation to the other group patients when they are allocated at once.
| Study group | Role | What they receive |
|---|---|---|
| NPPV | Experimental | Use the NPPV to treat moderate ARDS Receives: Procedure: noninvasive positive pressure ventilation (NPPV) |
| IMV | Active comparator | Use invasive mechanical ventilation in treating the patients allocated to this group. Receives: Procedure: invasive mechanical ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
all cause mortality
Measured: From the date of randomization to the date of discharge from ICU and hospital, or to the date of death of all cause, an expected average of 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2012 (estimated)
- Study startJul 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 Respiratory Distress SyndromeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Chen Wang, Beijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01585922
- Sponsor's protocol ID
- 20120418BIRM
- Status last verified
- Nov 2018
- First submitted
- 20 Apr 2012
- Last updated
- 21 Nov 2018
- Results posted
- No
Publications
Sun B, He H, Wang Z, Qu J, Li X, Ban C, Wan J, Cao B, Tong Z, Wang C. Emergent severe acute respiratory distress syndrome caused by adenovirus type 55 in immunocompetent adults in 2013: a prospective observational study. Crit Care. 2014 Aug 12;18(4):456. doi: 10.1186/s13054-014-0456-6.
PubMed 25112957
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
- Noninvasive Positive Pressure Ventilation in Moderate Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT01585922
- Acronym / sponsor ID
- 20120418BIRM
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- noninvasive positive pressure ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Beijing HospitalOther government
- Study start
- Jul 2012
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 26 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.
In order to identify the effect of noninvasive positive pressure ventilation (NPPV) on decreasing inflammatory response, improving the pathophysiological manifestation and reducing the morbidity and mortality in the moderate acute respiratory distress syndrome (ARDS) patients, the investigators conduct this clinical trial comparing NPPV with invasive mechanical ventilation in more than twenty ICUs in China.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NPPV | Experimental | Procedure: noninvasive positive pressure ventilation (NPPV)Use the NPPV to treat moderate ARDS |
| IMV | Active comparator | Procedure: invasive mechanical ventilationUse invasive mechanical ventilation in treating the patients allocated to this group. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- acute onset
- a clinical presentation of respiratory distress
- arterial oxygen tension/inspired oxygen fraction (PaO2/FiO2) between 200 mmHg to 300 mmHg. The arterial oxygen tension will be measured in fifteen minutes after NPPV (CPAP 5 cmH2O) was used to the patients stably
- presence of bilateral pulmonary infiltrate on chest radiograph
- no evidence of left heart failure as assessed by echocardiography and/or a pulmonary artery wedge pressure( PAWP) < 18 mmHg
Key exclusion criteria (14 listed)
- age > 70 years or < 18 years
- PaCO2 > 50mmHg
- Glasgow Coma Scale (GCS)< 11
- Upper airway/facial deformity or injury
- pneumothorax or pneumomediastinum
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 ventilation (NPPV)Use NPPV to treat the ARDS patients,and we choose the NPPV ventilators in which the FiO2 can be fixed, for example: the BiPAP Vision or V60 of Phillip Respironics. | Procedure or surgery | NPPV |
| invasive mechanical ventilationIntubate and give invasive mechanical ventilation to the other group patients when they are allocated at once. | Procedure or surgery | IMV |
Primary outcome
all cause mortality
Time frame: From the date of randomization to the date of discharge from ICU and hospital, or to the date of death of all cause, an expected average of 28 days
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 25112957Sun B, He H, Wang Z, Qu J, Li X, Ban C, Wan J, Cao B, Tong Z, Wang C. Emergent severe acute respiratory distress syndrome caused by adenovirus type 55 in immunocompetent adults in 2013: a prospective observational study. Crit Care. 2014 Aug 12;18(4):456. doi: 10.1186/s13054-014-0456-6.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 (NPPV) and invasive mechanical ventilation in people with Acute Respiratory Distress Syndrome, 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 5 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?
all cause mortality (time frame: From the date of randomization to the date of discharge from ICU and hospital, or to the date of death of all cause, an expected average of 28 days). 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 NCT01585922, 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.