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Recruitment Maneuver After Intubation

NCT ID: NCT01014299

Last Updated: 2009-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2009-11-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Hypoxemia

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Participants

Interventions

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Recruitment maneuver

Assigned interventions:

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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CHU Clermont-Ferrand

Principal Investigators

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Jean-Michel CONSTANTIN

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

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CHU Clermont-Ferrand

Clermont-Ferrand, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 19781900 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20426859 (View on PubMed)

Other Identifiers

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CHU-0061

Identifier Type: -

Identifier Source: org_study_id