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CompletedNCT01014299Updated Nov 25, 2009

Recruitment Maneuver After Intubation

A Phase 4 interventional study of Recruitment maneuver in Hypoxemia, sponsored by University Hospital, Clermont-Ferrand. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-11-25.

Sponsored by University Hospital, Clermont-Ferrand · Phase 4 and Interventional

Phase
Phase 4
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

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

Read the 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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Conditions studied

  • Hypoxemia

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Keywords

  • Intubation
  • Hypoxemia
  • Mechanical ventilation
  • Recruitment maneuver
  • Acute lung injury
  • Bacterial translocation
  • Hypoxemic ICU patients requiring invasive mechanical ventilation
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In context

Hypoxia

1,231 studies on the registry are indexed under Hypoxia; 241 are open to participants now.

This study's planned enrollment of 40 is below the median of 45 across 853 interventional studies indexed under Hypoxia.

Browse Hypoxia studies →

Lead sponsor

University Hospital, Clermont-Ferrand is the lead sponsor of 841 studies on the registry; 178 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion Criteria:

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

Phase
Phase 4
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
40 participants (estimated)

Interventions

  • OtherRecruitment maneuver

    Assigned interventions: * No intervention after tracheal intubation (control group) * Alveolar recruitment maneuver (RM group) immediately after intubation

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What researchers measure

Primary outcomes

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

    Time frame: 5 min after the onset of mechanical ventilation

Secondary outcomes

  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

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Study locations

1 site
  • CHU Clermont-Ferrand
    Clermont-Ferrand, 63000, France
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References and documents

Publications

  • 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. 2010 Mar;25(1):176.e1-6. doi: 10.1016/j.jcrc.2009.05.010. Epub 2009 Sep 24. PubMed 19781900 ↗
  • Constantin JM, Futier E, Cherprenet AL, Chanques G, Guerin R, Cayot-Constantin S, Jabaudon M, Perbet S, Chartier C, Jung B, Guelon D, Jaber S, Bazin JE. A recruitment maneuver increases oxygenation after intubation of hypoxemic intensive care unit patients: a randomized controlled study. Crit Care. 2010;14(2):R76. doi: 10.1186/cc8989. Epub 2010 Apr 28. PubMed 20426859 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 25, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01014299
Lead sponsor
University Hospital, Clermont-Ferrand
First posted
Nov 16, 2009
Start date
Dec 2008
Primary completion
Nov 2009
Completion
Nov 2009
Last update
Nov 25, 2009

Study contacts

Jean-Michel CONSTANTIN
principal investigator · University Hospital, Clermont-Ferrand
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2009. You cannot join it, but the record below documents what was studied.

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