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

NCT ID: NCT01114009

Last Updated: 2013-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2012-07-31

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.

Conditions

Acute Respiratory Distress Syndrome; Lung Injury, Acute

Keywords

recruitment maneuvers; ARDS; lung protective strategy; ARDS, Human

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Lung recruitment maneuver

Intervention Type: PROCEDURE

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

Lung protective strategy group

Intervention Type: PROCEDURE

Lung protective strategy group received Lung protective strategy without recruitment maneuver

Lung protective strategy

Lung protective strategy group received lung protective strategy without recruitment maneuver

Group Type: ACTIVE_COMPARATOR

Lung protective strategy group

Intervention Type: PROCEDURE

Lung protective strategy group received Lung protective strategy without recruitment maneuver

Interventions

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

Intervention Type: PROCEDURE

Lung protective strategy group

Lung protective strategy group received Lung protective strategy without recruitment maneuver

Intervention Type: PROCEDURE

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%

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chi Mei Medical Hospital

OTHER

Sponsor Role: collaborator

LUN WEI LIU

OTHER

Sponsor Role: lead

Responsible Party

LUN WEI LIU

Chi Mei Medical Hospital

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

WEI LUN LIU, MD

Role: PRINCIPAL_INVESTIGATOR

Chi Mei Medical Center, Liou Ying

Locations

Chi Mei Medical Center,Liou Ying

Tainan City, , Taiwan

Countries

Taiwan

Other Identifiers

CLFHR9803

Identifier Type: -

Identifier Source: org_study_id