Effects of Recruitment Maneuvers in Early Acute Lung Injury (ALI) and Acute Respiratory Distress Syndrome (ARDS) Patients
Primary Purpose
Acute Respiratory Distress Syndrome, Lung Injury, Acute
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Lung recruitment maneuver
Lung protective strategy group
Sponsored by
About this trial
This is an interventional treatment trial for Acute Respiratory Distress Syndrome focused on measuring recruitment maneuvers, ARDS, lung protective strategy, ARDS, Human
Eligibility Criteria
Inclusion Criteria:
- met criteria of ALI/ARDS
- PaO2/FiO2 less than or equal 250 mmHg after standard ventilator setting (FiO2 more than or equal 0.5 and PEEP more than or equal 10 cmH2O)at least 30 mins
Exclusion Criteria:
- age less than 18 years
- duration of mechanical ventilator more than 72 hours
- Pneumothorax or subcutaneous emphysema or bullous lung disease
- severe chronic respiratory disease
- intracranial hypertension or received craniotomy surgery
- longterm dependent ventilator
- Neuromuscular disease
- premorbid conditions with an expected 6 month mortality risk exceeding 50%
Sites / Locations
- Chi Mei Medical Center,Liou Ying
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Lung recruitment maneuver
Lung protective strategy
Arm Description
The maneuver briefly increases the alveolar pressure to open recruitable lung (50 cmH2O), sustained with adequate positive end-expiratory pressure(PEEP) after lung recruitment, to avoid derecruitment.
Lung protective strategy group received lung protective strategy without recruitment maneuver
Outcomes
Primary Outcome Measures
28-day hospital mortality
Secondary Outcome Measures
Ventilator-free days
Ventilator weaning rate
Cost-effectiveness analysis
ICU-free days
Full Information
NCT ID
NCT01114009
First Posted
April 26, 2010
Last Updated
August 1, 2013
Sponsor
LUN WEI LIU
Collaborators
Chi Mei Medical Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01114009
Brief Title
Effects of Recruitment Maneuvers in Early Acute Lung Injury (ALI) and Acute Respiratory Distress Syndrome (ARDS) Patients
Official Title
Effects of Recruitment Maneuvers in Early ALI and ARDS Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
LUN WEI LIU
Collaborators
Chi Mei Medical Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the effect of lung recruitment maneuver in patients with early ALI/ARDS
Detailed Description
The acute respiratory distress syndrome (ARDS) was first described in the medical literature in 1967. Patients with ARDS mostly require mechanical ventilatory support due to hypoxic respiratory failure. Mechanical ventilation can induce lung injury (ventilator-induced lung injury, VILI) by causing overdistention and repetitive opening and closing of unstable lung units. Data from a number of randomized controlled trials indicate that a lung protective ventilatory strategy with small tidal volume and low plateau pressure reduces mortality in acute lung injury (ALI) and acute respiratory distress syndrome. Lung recruitment maneuvers are being used in the management of ALI and ARDS, but recruitment maneuvers are still controversial. Lung recruitment maneuver is aimed to open the collapsed lung and keep the lung open. The maneuver briefly increases the alveolar pressure to open recruitable lung, sustained with adequate positive end-expiratory pressure(PEEP) after lung recruitment, to avoid derecruitment. We want to enroll 120 patients with early ALI/ARDS in this randomized controlled study. The study group use recruitment maneuver and lung protective ventilatory strategy, and the control group use lung protective ventilatory strategy only. Concerning about both safety and efficacy, we design a modified recruitment maneuver protocol which has never been published in previous medical literature. The primary outcome is ventilator-free days and ICU-free days, and secondary outcomes include ventilator weaning rate, and 28-day mortality and cost effectiveness analysis. Since no randomized controlled trials clearly establish benefit from recruitment maneuvers, we hope this study would be able to provide some evidence on whether lung recruitment should be used in the routine management of ALI/ARDS.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome, Lung Injury, Acute
Keywords
recruitment maneuvers, ARDS, lung protective strategy, ARDS, Human
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lung recruitment maneuver
Arm Type
Experimental
Arm Description
The maneuver briefly increases the alveolar pressure to open recruitable lung (50 cmH2O), sustained with adequate positive end-expiratory pressure(PEEP) after lung recruitment, to avoid derecruitment.
Arm Title
Lung protective strategy
Arm Type
Active Comparator
Arm Description
Lung protective strategy group received lung protective strategy without recruitment maneuver
Intervention Type
Procedure
Intervention Name(s)
Lung recruitment maneuver
Intervention Description
Lung recruitment maneuver conducted with a PEEP 35 cmH2O and peak inspiration pressure up to 50 cmH2O maintain 2 mins, then find the closing pressure (if possible), after that, PEEP is set higher 2 cmH2O above closing pressure
Intervention Type
Procedure
Intervention Name(s)
Lung protective strategy group
Intervention Description
Lung protective strategy group received Lung protective strategy without recruitment maneuver
Primary Outcome Measure Information:
Title
28-day hospital mortality
Time Frame
Two year
Secondary Outcome Measure Information:
Title
Ventilator-free days
Time Frame
Two year
Title
Ventilator weaning rate
Time Frame
Two years
Title
Cost-effectiveness analysis
Time Frame
Two years
Title
ICU-free days
Time Frame
Two years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
met criteria of ALI/ARDS
PaO2/FiO2 less than or equal 250 mmHg after standard ventilator setting (FiO2 more than or equal 0.5 and PEEP more than or equal 10 cmH2O)at least 30 mins
Exclusion Criteria:
age less than 18 years
duration of mechanical ventilator more than 72 hours
Pneumothorax or subcutaneous emphysema or bullous lung disease
severe chronic respiratory disease
intracranial hypertension or received craniotomy surgery
longterm dependent ventilator
Neuromuscular disease
premorbid conditions with an expected 6 month mortality risk exceeding 50%
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
WEI LUN LIU, MD
Organizational Affiliation
Chi Mei Medical Center, Liou Ying
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chi Mei Medical Center,Liou Ying
City
Tainan
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
Effects of Recruitment Maneuvers in Early Acute Lung Injury (ALI) and Acute Respiratory Distress Syndrome (ARDS) Patients
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