Noninvasive Positive Pressure Ventilation in Moderate Acute Respiratory Distress Syndrome

NCT ID: NCT01585922

Last Updated: 2018-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Respiratory Distress Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NPPV

Use the NPPV to treat moderate ARDS

Group Type EXPERIMENTAL

noninvasive positive pressure ventilation (NPPV)

Intervention Type PROCEDURE

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.

IMV

Use invasive mechanical ventilation in treating the patients allocated to this group.

Group Type ACTIVE_COMPARATOR

invasive mechanical ventilation

Intervention Type PROCEDURE

Intubate and give invasive mechanical ventilation to the other group patients when they are allocated at once.

Interventions

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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.

Intervention Type PROCEDURE

invasive mechanical ventilation

Intubate and give invasive mechanical ventilation to the other group patients when they are allocated at once.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. acute onset
2. a clinical presentation of respiratory distress
3. 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
4. presence of bilateral pulmonary infiltrate on chest radiograph
5. no evidence of left heart failure as assessed by echocardiography and/or a pulmonary artery wedge pressure( PAWP) \< 18 mmHg

Exclusion Criteria

1. age \> 70 years or \< 18 years
2. PaCO2 \> 50mmHg
3. Glasgow Coma Scale (GCS)\< 11
4. Upper airway/facial deformity or injury
5. pneumothorax or pneumomediastinum
6. unable to spontaneously clear secretions from their airway
7. respiratory arrest
8. severe ventricular arrhythmia or active myocardial ischemia
9. severe organ dysfunction (including gastrointestinal hemorrhage, disseminated intravascular coagulation, hepatic and renal dysfunction, SOFA score \> 1)
10. severe chronic lung diseases(COPD, Asthma or ILD, et al)
11. end-stage patients who are expected to survive less than six months
12. severe abdominal distension
13. refuse to receive NPPV
14. unable to cooperate with NPPV
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Chen Wang

Vice President

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Beijing Institute of Respiratory Medicine, Beijing Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 25112957 (View on PubMed)

Other Identifiers

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20120418BIRM

Identifier Type: -

Identifier Source: org_study_id

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