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

NCT01114009 | Completed DMC

• 1 other identifier: CLFHR9803
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acute Respiratory Distress Syndrome; Lung Injury, Acute

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 28-day hospital mortality

  Two year

Secondary Outcomes (4)

• Ventilator-free days

  Two year

• Ventilator weaning rate

  Two years

• Cost-effectiveness analysis

  Two years

• ICU-free days

  Two years

Study Arms (2)

Lung recruitment maneuver

EXPERIMENTAL

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; Procedure: Lung protective strategy group

Lung protective strategy

ACTIVE COMPARATOR

Lung protective strategy group received lung protective strategy without recruitment maneuver

Procedure: Lung protective strategy group

Interventions

Lung recruitment maneuver 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 recruitment maneuver

Lung protective strategy group PROCEDURE

Lung protective strategy group received Lung protective strategy without recruitment maneuver

Lung protective strategy; Lung recruitment maneuver

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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%

Sponsors & Collaborators

• LUN WEI LIU: lead
• Chi Mei Medical Hospital: collaborator

Study Sites (1)

Chi Mei Medical Center,Liou Ying

Tainan, Taiwan

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome; Acute Lung Injury

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Lung Injury

Study Officials

• WEI LUN LIU, MD

  Chi Mei Medical Center, Liou Ying

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chi Mei Medical Hospital

Study Record Dates

• First Submitted: April 26, 2010
• First Posted: April 30, 2010
• Study Start: March 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: July 1, 2012
• Last Updated: August 5, 2013

Record last verified: 2013-08

Locations

TW (1)