Recruitment Maneuver After Intubation

November 23, 2009 updated by: University Hospital, Clermont-Ferrand

Recruitment Maneuver Increases Oxygenation After Intubation in Hypoxemic ICU Patients: a Randomized Controlled Study

The purpose of this study is to evaluate the safety and efficacy of a recruitment maneuver immediately after intubation in hypoxemic patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In the intensive care unit (ICU), acute respiratory failure is a common problem. Airway management in critically ill patients usually requires endotracheal intubation after rapid sequence induction. Induction of anesthesia is a well known cause of dramatic changes in respiratory mechanics and gas exchange. Moreover, when the intubation is for respiratory failure, the underlying pathology increases these modifications. The reduction in lung volume results in a deep hypoxemia after intubation. Moreover, mechanical ventilation applied on a collapsed lung increases the risk of ventilator induced lung injury. Recruitment maneuver, which consists of a transient increased in inspiratory pressure, decreases anesthesia-induced lung collapse and hypoxemia. During early acute respiratory failure, RM increases oxygenation and lung volume and may reduce lung oedema. Some authors have suggested the potential benefit of an early RM after induction of anesthesia in operating room. To date, no study has evaluated the short term effect of a recruitment maneuver performed early after intubation in critically ill patients. Therefore, our aim was to ascertain whether RM, performed immediately after intubation, is safe and more effective at reducing hypoxemia than usual management, in hypoxemic patients requiring intubation for invasive ventilation in the ICU.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63000
        • Chu Clermont-Ferrand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • adults who met acute respiratory failure requiring intubation
  • adults who met hypoxemia, defined by a PaO2 less than 100 mm Hg under a high FiO2 mask driven by at least 10 L/min oxygen.

Exclusion Criteria:

  • encephalopathy
  • coma
  • cardiac resuscitation
  • hyperkaliemia (>5.5 mEq/L)
  • acute brain injury and recent thoracic surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Oxygenation (PaO2) measured 5 min after the onset of mechanical ventilation
Time Frame: 5 min after the onset of mechanical ventilation
5 min after the onset of mechanical ventilation

Secondary Outcome Measures

Outcome Measure
Time Frame
PaO2 at 30 min after intubation, hemodynamic and microbiologic safety, ICU length of stay, ICU mortality and mechanical ventilation duration.
Time Frame: at 30 min after intubation
at 30 min after intubation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

November 13, 2009

First Submitted That Met QC Criteria

November 13, 2009

First Posted (Estimate)

November 16, 2009

Study Record Updates

Last Update Posted (Estimate)

November 25, 2009

Last Update Submitted That Met QC Criteria

November 23, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHU-0061

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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