Recruitment Maneuver After Intubation

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT01014299
First received: November 13, 2009
Last updated: November 23, 2009
Last verified: November 2009
  Purpose

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


Condition Intervention Phase
Hypoxemia
Other: Recruitment maneuver
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: Recruitment Maneuver Increases Oxygenation After Intubation in Hypoxemic ICU Patients: a Randomized Controlled Study

Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • Oxygenation (PaO2) measured 5 min after the onset of mechanical ventilation [ Time Frame: 5 min after the onset of mechanical ventilation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: December 2008
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Recruitment maneuver

    Assigned interventions:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01014299

Locations
France
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63000
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
Principal Investigator: Jean-Michel CONSTANTIN University Hospital, Clermont-Ferrand
  More Information

Publications:
Responsible Party: Patrick LACARIN, CHU Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01014299     History of Changes
Other Study ID Numbers: CHU-0061
Study First Received: November 13, 2009
Last Updated: November 23, 2009
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:
Intubation
Hypoxemia
Mechanical ventilation
Recruitment maneuver
Acute lung injury
Bacterial translocation
Hypoxemic ICU patients requiring invasive mechanical ventilation

Additional relevant MeSH terms:
Anoxia
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on July 23, 2014