Airway Pressure Release Ventilation (APRV) Protocol Early Used in Acute Respiratory Distress Syndrome

NCT02639364 | Unknown DMC

• 1 other identifier: 2015 approval (156)
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to assess the effects and safety of the early application of BILEVEL-APRV protocol and conventional ventilation strategy that used low tidal volume and adequate PEEP level in ARDS patients .

Conditions

Acute Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (1)

• Mechanical ventilation free days

  day 28

Secondary Outcomes (19)

• all causes mortality

  day 60

• all cause hospital mortality

  day 60

• Duration of stay in ICU

  day 60

• Duration of hospital stay

  day 60

• peak airway pressure,mean airway pressure,positive end expiratory pressure(cmH2O)

  day 7

Study Arms (2)

conventional ventilation strategy

ACTIVE COMPARATOR

The conventional ventilation strategy use volume-controlled ventilation (VCV) or pressure-controlled ventilation (PCV) mode, combination with low tidal volume and adequate PEEP level.

Device: Nellcor Puritan Bennett 840 ventilator system

BILEVEL-APRV protocol

EXPERIMENTAL

According to our BILEVEL-APRV protocol, BILEVEL-APRV APRV mode with specific settings,combination with spontaneous breathing.

Device: Nellcor Puritan Bennett 840 ventilator system

Interventions

Nellcor Puritan Bennett 840 ventilator system DEVICE

Puritan Bennett 840 ventilator can provide the VCV,PCV,Bi-level Airway Pressure Ventilation-airway Pressure Release Ventilation(BILEVER-APRV) mode.

BILEVEL-APRV protocol; conventional ventilation strategy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute respiratory distress syndrome,according to the Berlin definition of ARDS, - The receipt of endotracheal mechanical ventilation for a period was no longer than 48 hours
• A ratio of the partial pressure of arterial oxygen (PaO2) to the fraction of inspired oxygen(FiO2) was less than 250.

You may not qualify if:

• Pregnancy
• The expected duration of mechanical ventilation was less than 48 hours
• Intracranial hypertension (suspected or confirmed)
• Neuromuscular disorders that are known to prolong the need for mechanical ventilation
• Known or suspected chronic obstructive pulmonary disease(COPD)
• Preexisting conditions with an expected 6-month mortality exceeding 50%
• Pneumothorax (drained or not)at enrollment
• Treatment with extracorporeal support (ECMO) at enrollment
• There was a lack of commitment to life support.

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

Department of Critical care medicine of West China Hospital

Chengdu, Sichuan, 610041, China

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Yan Kang, doctor

  West China Hospital

  STUDY DIRECTOR

Central Study Contacts

Yongfang Zhou, master

CONTACT

8618140212276; zyfmg@163.com

Study Design

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

Study Record Dates

• First Submitted: December 13, 2015
• First Posted: December 24, 2015
• Study Start: May 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 28, 2015

Record last verified: 2015-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)