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

NCT ID: NCT02639364

Last Updated: 2015-12-28

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2016-12-31

Brief Summary

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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 .

Detailed Description

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Although mechanical ventilation is life-sustaining for patients with ARDS, it can perpetuate lung injury. A number of recent advances have greatly improved in the mechanical ventilation strategies and treatment for acute respiratory distress syndrome (ARDS), however, Mortality remains high, even with the use of low tidal volume and adequate positive end expiratory pressure(PEEP). Numerous experimental showed that the BILEVEL-APRV mode used in animal ARDS model can improve gas exchanges and hemodynamic tolerance of the ventilation while reducing the dosage for sedative drugs.

The aim of this single-center, prospective, randomized, controlled, open study is to compare 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

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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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conventional ventilation strategy

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

Group Type ACTIVE_COMPARATOR

Nellcor Puritan Bennett 840 ventilator system

Intervention Type 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

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

Group Type EXPERIMENTAL

Nellcor Puritan Bennett 840 ventilator system

Intervention Type DEVICE

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

Interventions

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Nellcor Puritan Bennett 840 ventilator system

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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West China Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhou Yongfang

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yan Kang, doctor

Role: STUDY_DIRECTOR

West China Hospital

Locations

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Department of Critical care medicine of West China Hospital

Chengdu, Sichuan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yongfang Zhou, master

Role: CONTACT

Phone: 8618140212276

Email: [email protected]

Facility Contacts

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Y F zhou, MM

Role: primary

Other Identifiers

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2015 approval (156)

Identifier Type: -

Identifier Source: org_study_id