Preoxygenation Using NIV in Hypoxemic Patients - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

May 10, 2007

Last Updated Date

July 17, 2008

Start Date ^†

June 2007

Current Primary Outcome Measures ^†

The maximum Sequential organ failure assessment (SOFA) score observed during the first week following endotracheal intubation. [ Time Frame: the first week ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00472160 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

The mean drop in SpO2 during endotracheal intubation. [ Time Frame: during the intubation ] [ Designated as safety issue: Yes ]
Number of organ failures (SOFA score >2) [ Time Frame: during the 7 days after intubation ] [ Designated as safety issue: Yes ]
ICU length of stay [ Time Frame: during the stay in reanimation ] [ Designated as safety issue: Yes ]
Mortality [ Time Frame: in reanimation ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Preoxygenation Using NIV in Hypoxemic Patients

Official Title ^†

Preoxygenation Using Noninvasive Ventilation Prior Intubation in Hypoxemic Patients

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.

Detailed Description

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.

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^†

Critically Ill Patients
Hypoxemic

Intervention ^†

Procedure: Non Invasive Ventilation

Study Arms / Comparison Groups

Experimental: Non Invasive Ventilation

Publications *

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. Epub 2006 Apr 20.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Estimated Enrollment ^†

200

Estimated Completion Date

March 2009

Estimated Primary Completion Date

March 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion Criteria:

Adults patients with acute respiratory failure requiring intubation

Exclusion Criteria:

Encephalopathy or coma, cardiac resuscitation

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Contact: Christophe BAILLARD, MD,PhD

+33(0) 1 48 95 55 91

christophe.baillard@avc.aphp.fr

Location Countries ^†

France

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00472160

Responsible Party

Cecile JOURDAIN, Department Clinical Research of Developpement

Secondary IDs ^††

Study Sponsor ^†

Assistance Publique - Hôpitaux de Paris

Collaborators ^††

Investigators ^†

Principal Investigator:

Christophe BAILLARD, MD,PhD

Assistance Publique - Hôpitaux de Paris

Information Provided By

Assistance Publique - Hôpitaux de Paris

Verification Date

May 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.