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

November 13, 2009
November 23, 2009
December 2008
November 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01014299 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Recruitment Maneuver After Intubation
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Hypoxemia
Other: Recruitment maneuver

Assigned interventions:

  • No intervention after tracheal intubation (control group)
  • Alveolar recruitment maneuver (RM group) immediately after intubation
Not Provided
Constantin JM, Futier E, Perbet S, Roszyk L, Lautrette A, Gillart T, Guerin R, Jabaudon M, Souweine B, Bazin JE, Sapin V. Plasma neutrophil gelatinase-associated lipocalin is an early marker of acute kidney injury in adult critically ill patients: A prospective study. J Crit Care. 2009 Sep 23; [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
November 2009
November 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01014299
CHU-0061
Not Provided
Patrick LACARIN, CHU Clermont-Ferrand
University Hospital, Clermont-Ferrand
Not Provided
Principal Investigator: Jean-Michel CONSTANTIN University Hospital, Clermont-Ferrand
University Hospital, Clermont-Ferrand
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP