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

Primary Purpose

Acute Respiratory Distress Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Nellcor Puritan Bennett 840 ventilator system
Sponsored by
West China Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Respiratory Distress Syndrome

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Critical care medicine of West China HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

conventional ventilation strategy

BILEVEL-APRV protocol

Arm Description

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

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

Outcomes

Primary Outcome Measures

Mechanical ventilation free days

Secondary Outcome Measures

all causes mortality
Participants will be followed for the duration of ICU stay
all cause hospital mortality
Participants will be followed for the duration of hospital stay, until day 60 maximum.
Duration of stay in ICU
Duration of hospital stay
peak airway pressure,mean airway pressure,positive end expiratory pressure(cmH2O)
Average dosage of sedative infusion
Richmond Sedation-Agitation Scale
Average dosage of vasoactive drugs each day in use
number of patients requiring cointerventions and Adjunctive Therapies
number of patients requiring the use of noninvasive ventilation
the tracheotomy rate
Number of patients with a pneumothorax
the number of days free from organ dysfunction
tidal volume(ml)
static lung compliance（ml/cmH2O）
PaO2,PaCO2(mmHg)
Blood pressure(mmHg)
blood lactic acid（mmol/l）
minute ventilation (L)

Full Information

First Posted
December 13, 2015
Last Updated
December 24, 2015
Sponsor
West China Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02639364
Brief Title
Airway Pressure Release Ventilation (APRV) Protocol Early Used in Acute Respiratory Distress Syndrome
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
May 2015 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West China Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 .
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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
conventional ventilation strategy
Arm Type
Active Comparator
Arm Description
The conventional ventilation strategy use volume-controlled ventilation (VCV) or pressure-controlled ventilation (PCV) mode, combination with low tidal volume and adequate PEEP level.
Arm Title
BILEVEL-APRV protocol
Arm Type
Experimental
Arm Description
According to our BILEVEL-APRV protocol, BILEVEL-APRV APRV mode with specific settings,combination with spontaneous breathing.
Intervention Type
Device
Intervention Name(s)
Nellcor Puritan Bennett 840 ventilator system
Intervention Description
Puritan Bennett 840 ventilator can provide the VCV,PCV,Bi-level Airway Pressure Ventilation-airway Pressure Release Ventilation(BILEVER-APRV) mode.
Primary Outcome Measure Information:
Title
Mechanical ventilation free days
Time Frame
day 28
Secondary Outcome Measure Information:
Title
all causes mortality
Description
Participants will be followed for the duration of ICU stay
Time Frame
day 60
Title
all cause hospital mortality
Description
Participants will be followed for the duration of hospital stay, until day 60 maximum.
Time Frame
day 60
Title
Duration of stay in ICU
Time Frame
day 60
Title
Duration of hospital stay
Time Frame
day 60
Title
peak airway pressure,mean airway pressure,positive end expiratory pressure(cmH2O)
Time Frame
day 7
Title
Average dosage of sedative infusion
Time Frame
day 7
Title
Richmond Sedation-Agitation Scale
Time Frame
day 7
Title
Average dosage of vasoactive drugs each day in use
Time Frame
day 7
Title
number of patients requiring cointerventions and Adjunctive Therapies
Time Frame
Day 28
Title
number of patients requiring the use of noninvasive ventilation
Time Frame
Day 28
Title
the tracheotomy rate
Time Frame
Day 28
Title
Number of patients with a pneumothorax
Time Frame
Day 28
Title
the number of days free from organ dysfunction
Time Frame
Day 28
Title
tidal volume(ml)
Time Frame
Day 7
Title
static lung compliance（ml/cmH2O）
Time Frame
Day 7
Title
PaO2,PaCO2(mmHg)
Time Frame
Day 7
Title
Blood pressure(mmHg)
Time Frame
Day 7
Title
blood lactic acid（mmol/l）
Time Frame
Day 7
Title
minute ventilation (L)
Time Frame
Day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yongfang Zhou, master
Phone
8618140212276
Email
zyfmg@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yan Kang, doctor
Organizational Affiliation
West China Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Department of Critical care medicine of West China Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Y F zhou, MM
Phone
8613880012276
First Name & Middle Initial & Last Name & Degree
Y F Zhou, MM

12. IPD Sharing Statement

Plan to Share IPD
No

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

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