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Completed

NCT Number: NCT01114009

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

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

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chi Mei Medical Center,Liou Ying

Tainan, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

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 protective strategy group

Procedure

Lung protective strategy group received Lung protective strategy without recruitment maneuver

Primary outcomes

  1. 28-day hospital mortality

    Time frame: Two year

Secondary outcomes

  1. Ventilator-free days

    Time frame: Two year

  2. Ventilator weaning rate

    Time frame: Two years

  3. Cost-effectiveness analysis

    Time frame: Two years

  4. ICU-free days

    Time frame: Two years

Sponsors and collaborators

Lead sponsor

LUN WEI LIU

Other

Collaborators

  • Chi Mei Medical Hospital

Registry information

Official study title

Effects of Recruitment Maneuvers in Early ALI and ARDS Patients

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Apr 30, 2010
Registry last updated
Aug 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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