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

Effects of Recruitment Maneuvers in Early ALI and ARDS Patients

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

Study Overview

• Status: Completed
• Conditions: Acute Respiratory Distress Syndrome; Lung Injury, Acute
• Intervention / Treatment: Procedure: Lung recruitment maneuver; Procedure: Lung protective strategy group

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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Tainan, Taiwan
    • Chi Mei Medical Center,Liou Ying

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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%

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
28-day hospital mortality	Two year

Secondary Outcome Measures

Outcome Measure	Time Frame
Ventilator-free days	Two year
Ventilator weaning rate	Two years
Cost-effectiveness analysis	Two years
ICU-free days	Two years

Collaborators and Investigators

• Sponsor: LUN WEI LIU
• Collaborators: Chi Mei Medical Hospital
• Investigators: Principal Investigator: WEI LUN LIU, MD, Chi Mei Medical Center, Liou Ying

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: April 26, 2010
• First Submitted That Met QC Criteria: April 29, 2010
• First Posted (Estimate): April 30, 2010

Study Record Updates

• Last Update Posted (Estimate): August 5, 2013
• Last Update Submitted That Met QC Criteria: August 1, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: ARDS; recruitment maneuvers; lung protective strategy; ARDS, Human
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Wounds and Injuries; Disease; Infant, Newborn, Diseases; Infant, Premature, Diseases; Thoracic Injuries; Syndrome; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Lung Injury
• Other Study ID Numbers: CLFHR9803