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Recruitment Maneuver After Intubation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01014299
Recruitment Status : Completed
First Posted : November 16, 2009
Last Update Posted : November 25, 2009
Information provided by:
University Hospital, Clermont-Ferrand

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

Condition or disease Intervention/treatment Phase
Hypoxemia Other: Recruitment maneuver Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Official Title: Recruitment Maneuver Increases Oxygenation After Intubation in Hypoxemic ICU Patients: a Randomized Controlled Study
Study Start Date : December 2008
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

Intervention Details:
  • Other: Recruitment maneuver

    Assigned interventions:

    • No intervention after tracheal intubation (control group)
    • Alveolar recruitment maneuver (RM group) immediately after intubation

Primary Outcome Measures :
  1. Oxygenation (PaO2) measured 5 min after the onset of mechanical ventilation [ Time Frame: 5 min after the onset of mechanical ventilation ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01014299

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CHU Clermont-Ferrand
Clermont-Ferrand, France, 63000
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
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Principal Investigator: Jean-Michel CONSTANTIN University Hospital, Clermont-Ferrand
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Patrick LACARIN, CHU Clermont-Ferrand Identifier: NCT01014299    
Other Study ID Numbers: CHU-0061
First Posted: November 16, 2009    Key Record Dates
Last Update Posted: November 25, 2009
Last Verified: November 2009
Keywords provided by University Hospital, Clermont-Ferrand:
Mechanical ventilation
Recruitment maneuver
Acute lung injury
Bacterial translocation
Hypoxemic ICU patients requiring invasive mechanical ventilation
Additional relevant MeSH terms:
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Signs and Symptoms, Respiratory