Effects of Recruitment Maneuvers in Early Acute Lung Injury (ALI) and Acute Respiratory Distress Syndrome (ARDS) Patients

Sponsor

LUN WEI LIU (Other)

Overall Status

Completed

CT.gov ID

NCT01114009

Collaborator

Chi Mei Medical Hospital (Other)

120

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the effect of lung recruitment maneuver in patients with early ALI/ARDS

Condition or Disease	Intervention/Treatment	Phase
Acute Respiratory Distress Syndrome Lung Injury, Acute	Procedure: Lung recruitment maneuver Procedure: Lung protective strategy group	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Effects of Recruitment Maneuvers in Early ALI and ARDS Patients

Study Start Date :

Mar 1, 2009

Actual Primary Completion Date :

Dec 1, 2011

Actual Study Completion Date :

Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lung recruitment maneuver 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.	Procedure: Lung recruitment maneuver 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 Procedure: Lung protective strategy group Lung protective strategy group received Lung protective strategy without recruitment maneuver
Active Comparator: Lung protective strategy Lung protective strategy group received lung protective strategy without recruitment maneuver	Procedure: Lung protective strategy group Lung protective strategy group received Lung protective strategy without recruitment maneuver

Arm

Intervention/Treatment

Experimental: Lung recruitment maneuver

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.

Procedure: Lung recruitment maneuver

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

Procedure: Lung protective strategy group

Lung protective strategy group received Lung protective strategy without recruitment maneuver

Active Comparator: Lung protective strategy

Lung protective strategy group received lung protective strategy without recruitment maneuver

Procedure: Lung protective strategy group

Lung protective strategy group received Lung protective strategy without recruitment maneuver

Outcome Measures

Primary Outcome Measures

28-day hospital mortality [Two year]

Secondary Outcome Measures

Ventilator-free days [Two year]
Ventilator weaning rate [Two years]
Cost-effectiveness analysis [Two years]
ICU-free days [Two years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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