Clinical trial NCT01114009: Effects of Recruitment Maneuvers in Early Acute Lung Injury (ALI) and Acute Respiratory Distress Syndrome (ARDS) Patients
Official title: Effects of Recruitment Maneuvers in Early ALI and ARDS Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Respiratory Distress Syndrome
Lung Injury, Acute
Keywords: recruitment maneuvers
ARDS
lung protective strategy
ARDS, Human
Lead sponsor: Chi Mei Medical Hospital
Sponsor class: OTHER
Collaborators: name: Chi Mei Medical Hospital
First posted: 2010-04-30
Enrollment: 120
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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%

Primary outcomes:
measure: 28-day hospital mortality
timeFrame: Two year
Secondary outcomes:
measure: Ventilator-free days
timeFrame: Two year
measure: Ventilator weaning rate
timeFrame: Two years
measure: Cost-effectiveness analysis
timeFrame: Two years
measure: ICU-free days
timeFrame: Two years
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: Chi Mei Medical Center,Liou Ying
Study officials:
affiliation: Chi Mei Medical Center, Liou Ying
name: WEI LUN LIU, MD
role: PRINCIPAL_INVESTIGATOR
References: