NCT00472160

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2007

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 11, 2007

Completed
21 days until next milestone

Study Start

First participant enrolled

June 1, 2007

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

March 28, 2011

Status Verified

May 1, 2007

Enrollment Period

3 years

First QC Date

May 10, 2007

Last Update Submit

March 25, 2011

Conditions

Critical IllnessHypoxemia

Keywords

PreoxygenationNon Invasive VentilationContinuous Positive Airway Pressure,Intubation,Organ failure

Outcome Measures

Primary Outcomes (1)

  • The maximum Sequential organ failure assessment (SOFA) score observed during the first week following endotracheal intubation.

    the first week

Secondary Outcomes (4)

  • The mean drop in SpO2 during endotracheal intubation.

    during the intubation

  • Number of organ failures (SOFA score >2)

    during the 7 days after intubation

  • ICU length of stay

    during the stay in reanimation

  • Mortality

    in reanimation

Study Arms (1)

1

EXPERIMENTAL

Non Invasive Ventilation

Procedure: Non Invasive Ventilation

Interventions

Non Invasive VentilationPROCEDURE

Non Invasive Ventilation

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults patients with acute respiratory failure requiring intubation

You may not qualify if:

  • Encephalopathy or coma, cardiac resuscitation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital de Bobigny

Bobigny, 93009, France

Location

Related Publications (2)

  • 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.

    PMID: 16627862RESULT

  • 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.

    PMID: 29406184DERIVED

MeSH Terms

Conditions

Critical IllnessHypoxia

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms, RespiratorySigns and Symptoms

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Christophe BAILLARD, MD,PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 10, 2007

First Posted

May 11, 2007

Study Start

June 1, 2007

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

March 28, 2011

Record last verified: 2007-05

Locations

FR(1)