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

December 24, 2015 updated by: Zhou Yongfang, West China Hospital

the Effects and Safety of the Early Application of Bi-level Airway Pressure Ventilation-airway Pressure Release Ventilation(BILEVEL-APRV) Protocol and Conventional Ventilation Strategy Were Compared in ARDS Patients

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 .

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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 .

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Yongfang Zhou, master
  • Phone Number: 8618140212276
  • Email: zyfmg@163.com

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • Department of Critical care medicine of West China Hospital
        • Contact:
          • Y F zhou, MM
          • Phone Number: 8613880012276
        • Principal Investigator:
          • Y F Zhou, MM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 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.
Device: 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.
Experimental: BILEVEL-APRV protocol
According to our BILEVEL-APRV protocol, BILEVEL-APRV APRV mode with specific settings,combination with spontaneous breathing.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Mechanical ventilation free days
Time Frame: day 28
day 28

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
all causes mortality
Time Frame: day 60
Participants will be followed for the duration of ICU stay
day 60
all cause hospital mortality
Time Frame: day 60
Participants will be followed for the duration of hospital stay, until day 60 maximum.
day 60
Duration of stay in ICU
Time Frame: day 60
day 60
Duration of hospital stay
Time Frame: day 60
day 60
peak airway pressure,mean airway pressure,positive end expiratory pressure(cmH2O)
Time Frame: day 7
day 7
Average dosage of sedative infusion
Time Frame: day 7
day 7
Richmond Sedation-Agitation Scale
Time Frame: day 7
day 7
Average dosage of vasoactive drugs each day in use
Time Frame: day 7
day 7
number of patients requiring cointerventions and Adjunctive Therapies
Time Frame: Day 28
Day 28
number of patients requiring the use of noninvasive ventilation
Time Frame: Day 28
Day 28
the tracheotomy rate
Time Frame: Day 28
Day 28
Number of patients with a pneumothorax
Time Frame: Day 28
Day 28
the number of days free from organ dysfunction
Time Frame: Day 28
Day 28
tidal volume(ml)
Time Frame: Day 7
Day 7
static lung compliance（ml/cmH2O）
Time Frame: Day 7
Day 7
PaO2,PaCO2(mmHg)
Time Frame: Day 7
Day 7
Blood pressure(mmHg)
Time Frame: Day 7
Day 7
blood lactic acid（mmol/l）
Time Frame: Day 7
Day 7
minute ventilation (L)
Time Frame: Day 7
Day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
West China Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Yan Kang, doctor, West China Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2016

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 13, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 21, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 24, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 28, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 24, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2015 approval (156)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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