Noninvasive Positive Pressure Ventilation in Moderate Acute Respiratory Distress Syndrome

NCT01585922 | Completed

• 1 other identifier: 20120418BIRM
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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 trial comparing NPPV with invasive mechanical ventilation in more than twenty ICUs in China.

Conditions

Acute Respiratory Distress Syndrome

Keywords

noninvasive positive pressure ventilation

Outcome Measures

Primary Outcomes (1)

• all cause mortality

  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

Study Arms (2)

NPPV

EXPERIMENTAL

Use the NPPV to treat moderate ARDS

Procedure: noninvasive positive pressure ventilation (NPPV)

IMV

ACTIVE COMPARATOR

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

Procedure: invasive mechanical ventilation

Interventions

noninvasive positive pressure ventilation (NPPV) 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.

NPPV

invasive mechanical ventilation PROCEDURE

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

IMV

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Beijing Hospital: lead

Study Sites (1)

Beijing Institute of Respiratory Medicine, Beijing Hospital

Beijing, Beijing Municipality, 100020, China

Location

Related Publications (1)

• 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.

  PMID: 25112957 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President

Study Record Dates

• First Submitted: April 20, 2012
• First Posted: April 26, 2012
• Study Start: July 1, 2012
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: November 21, 2018

Record last verified: 2018-11

Locations

CN (1)