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

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: Unknown
• Conditions: Acute Respiratory Distress Syndrome
• Intervention / Treatment: Device: Nellcor Puritan Bennett 840 ventilator system

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: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Time Frame
Mechanical ventilation free days	day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
all causes mortality	Participants will be followed for the duration of ICU stay	day 60
all cause hospital mortality	Participants will be followed for the duration of hospital stay, until day 60 maximum.	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
Average dosage of sedative infusion		day 7
Richmond Sedation-Agitation Scale		day 7
Average dosage of vasoactive drugs each day in use		day 7
number of patients requiring cointerventions and Adjunctive Therapies		Day 28
number of patients requiring the use of noninvasive ventilation		Day 28
the tracheotomy rate		Day 28
Number of patients with a pneumothorax		Day 28
the number of days free from organ dysfunction		Day 28
tidal volume(ml)		Day 7
static lung compliance（ml/cmH2O）		Day 7
PaO2,PaCO2(mmHg)		Day 7
Blood pressure(mmHg)		Day 7
blood lactic acid（mmol/l）		Day 7
minute ventilation (L)		Day 7

Collaborators and Investigators

• Sponsor: West China Hospital
• Investigators: Study Director: Yan Kang, doctor, West China Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: December 13, 2015
• First Submitted That Met QC Criteria: December 21, 2015
• First Posted (Estimate): December 24, 2015

Study Record Updates

• Last Update Posted (Estimate): December 28, 2015
• Last Update Submitted That Met QC Criteria: December 24, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Syndrome; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: 2015 approval (156)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No