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

Acute Respiratory Distress Syndrome Clinical Trial

Official title:

Effects of Recruitment Maneuvers in Early ALI and ARDS Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01114009
• Other study ID #: CLFHR9803
• Status: Completed
• Phase: N/A
• First received: April 26, 2010
• Last updated: August 1, 2013
• Start date: March 2009
• Est. completion date: July 2012

Study information

• Verified date: August 2013
• Source: Chi Mei Medical Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Lung Injury
• Lung Injury, Acute
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

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
• Lung protective strategy group
Lung protective strategy group received Lung protective strategy without recruitment maneuver

Locations

Country	Name	City	State
Taiwan	Chi Mei Medical Center,Liou Ying	Tainan

Sponsors (2)

Lead Sponsor	Collaborator
LUN WEI LIU	Chi Mei Medical Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	28-day hospital mortality		Two year	No
Secondary	Ventilator-free days		Two year	No
Secondary	Ventilator weaning rate		Two years	No
Secondary	Cost-effectiveness analysis		Two years	No
Secondary	ICU-free days		Two years	No