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Preoxygenation Using NIV in Hypoxemic Patients

NCT ID: NCT00472160

Last Updated: 2011-03-28

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

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2010-06-30

Brief Summary

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Critically ill patients are predisposed to oxyhaemoglobin desaturation during intubation. For the intubation of hypoxemic patients, preoxygenation using non invasive ventilation (NIV) is more effective at reducing arterial oxyhaemoglobin desaturation than standard method.

Objectives: To find out whether NIV, as a preoxygenation method, is more effective at reducing the degree of organ dysfunction/failure than standard preoxygenation during the week following endotracheal intubation.

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Detailed Description

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During the inclusion period (at least 10 min and maximum 30 min), the patients ware a high FiO2 mask, driven by 10-15L/min oxygen and are randomly assigned to control or NIV group. Preoxygenation is then performed for a 3 minute period prior to a standardized rapid sequence intubation. For the control group, preoxygenation use a non-re-breather bag-valve mask driven by 15L/min oxygen. Patients allow to breath spontaneously with occasional assists (usual preoxygenation method). For the NIV group, pressure support mode is delivered by an ICU ventilator through a face mask adjusted to obtain an expired tidal volume of 7 to 10 mL/kg. The fraction of inspired oxygen (FiO2) was 100% and we used a PEEP level of 5 cmH2O.

Conditions

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Critical Illness Hypoxemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

Non Invasive Ventilation

Group Type EXPERIMENTAL

Non Invasive Ventilation

Intervention Type PROCEDURE

Non Invasive Ventilation

Interventions

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Non Invasive Ventilation

Non Invasive Ventilation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Adults patients with acute respiratory failure requiring intubation

Exclusion Criteria

* Encephalopathy or coma, cardiac resuscitation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Department Clinical Research of Developpement

Principal Investigators

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Christophe BAILLARD, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Hopital de Bobigny

Bobigny, , France

Site Status

Countries

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France

References

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Baillard C, Fosse JP, Sebbane M, Chanques G, Vincent F, Courouble P, Cohen Y, Eledjam JJ, Adnet F, Jaber S. Noninvasive ventilation improves preoxygenation before intubation of hypoxic patients. Am J Respir Crit Care Med. 2006 Jul 15;174(2):171-7. doi: 10.1164/rccm.200509-1507OC. Epub 2006 Apr 20.

Reference Type RESULT
PMID: 16627862 (View on PubMed)

Baillard C, Prat G, Jung B, Futier E, Lefrant JY, Vincent F, Hamdi A, Vicaut E, Jaber S. Effect of preoxygenation using non-invasive ventilation before intubation on subsequent organ failures in hypoxaemic patients: a randomised clinical trial. Br J Anaesth. 2018 Feb;120(2):361-367. doi: 10.1016/j.bja.2017.11.067. Epub 2017 Nov 23.

Reference Type DERIVED
PMID: 29406184 (View on PubMed)

Other Identifiers

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P060230

Identifier Type: -

Identifier Source: org_study_id

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