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Clinical Trials/NCT01014299
NCT01014299
Completed
Phase 4

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

University Hospital, Clermont-Ferrand1 site in 1 country40 target enrollmentDecember 2008
ConditionsHypoxemia

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Hypoxemia
Sponsor
University Hospital, Clermont-Ferrand
Enrollment
40
Locations
1
Primary Endpoint
Oxygenation (PaO2) measured 5 min after the onset of mechanical ventilation
Status
Completed
Last Updated
16 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
December 2008
End Date
November 2009
Last Updated
16 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital, Clermont-Ferrand

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

Outcomes

Primary Outcomes

Oxygenation (PaO2) measured 5 min after the onset of mechanical ventilation

Time Frame: 5 min after the onset of mechanical ventilation

Secondary Outcomes

  • PaO2 at 30 min after intubation, hemodynamic and microbiologic safety, ICU length of stay, ICU mortality and mechanical ventilation duration.(at 30 min after intubation)

Study Sites (1)

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