Recruitment Maneuver After Intubation
Recruitment Maneuver Increases Oxygenation After Intubation in Hypoxemic ICU Patients: a Randomized Controlled Study
1 other identifier
interventional
40
1 country
1
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of a recruitment maneuver immediately after intubation in hypoxemic patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Dec 2008
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 13, 2009
CompletedFirst Posted
Study publicly available on registry
November 16, 2009
CompletedNovember 25, 2009
November 1, 2009
11 months
November 13, 2009
November 23, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Oxygenation (PaO2) measured 5 min after the onset of mechanical ventilation
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.
at 30 min after intubation
Interventions
Assigned interventions: * No intervention after tracheal intubation (control group) * Alveolar recruitment maneuver (RM group) immediately after intubation
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- encephalopathy
- coma
- cardiac resuscitation
- hyperkaliemia (\>5.5 mEq/L)
- acute brain injury and recent thoracic surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Clermont-Ferrand
Clermont-Ferrand, 63000, France
Related Publications (2)
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.
PMID: 19781900BACKGROUNDConstantin 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.
PMID: 20426859DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean-Michel CONSTANTIN
University Hospital, Clermont-Ferrand
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 13, 2009
First Posted
November 16, 2009
Study Start
December 1, 2008
Primary Completion
November 1, 2009
Study Completion
November 1, 2009
Last Updated
November 25, 2009
Record last verified: 2009-11