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Preoxygenation Using NIV in Hypoxemic Patients (PREOXY)

Primary Purpose

Critical Illness, Hypoxemia

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Non Invasive Ventilation
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Critical Illness focused on measuring Preoxygenation, Non Invasive Ventilation, Continuous Positive Airway Pressure,, Intubation,, Organ failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adults patients with acute respiratory failure requiring intubation

Exclusion Criteria:

  • Encephalopathy or coma, cardiac resuscitation

Sites / Locations

  • Hopital de Bobigny

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Non Invasive Ventilation

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

The mean drop in SpO2 during endotracheal intubation.
Number of organ failures (SOFA score >2)
ICU length of stay
Mortality

Full Information

First Posted
May 10, 2007
Last Updated
March 25, 2011
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT00472160
Brief Title
Preoxygenation Using NIV in Hypoxemic Patients
Acronym
PREOXY
Official Title
Preoxygenation Using Noninvasive Ventilation Prior Intubation in Hypoxemic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2007
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness, Hypoxemia
Keywords
Preoxygenation, Non Invasive Ventilation, Continuous Positive Airway Pressure,, Intubation,, Organ failure

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Non Invasive Ventilation
Intervention Type
Procedure
Intervention Name(s)
Non Invasive Ventilation
Intervention Description
Non Invasive Ventilation
Primary Outcome Measure Information:
Title
The maximum Sequential organ failure assessment (SOFA) score observed during the first week following endotracheal intubation.
Time Frame
the first week
Secondary Outcome Measure Information:
Title
The mean drop in SpO2 during endotracheal intubation.
Time Frame
during the intubation
Title
Number of organ failures (SOFA score >2)
Time Frame
during the 7 days after intubation
Title
ICU length of stay
Time Frame
during the stay in reanimation
Title
Mortality
Time Frame
in reanimation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults patients with acute respiratory failure requiring intubation Exclusion Criteria: Encephalopathy or coma, cardiac resuscitation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christophe BAILLARD, MD,PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital de Bobigny
City
Bobigny
ZIP/Postal Code
93009
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
16627862
Citation
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.
Results Reference
result
PubMed Identifier
29406184
Citation
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.
Results Reference
derived

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Preoxygenation Using NIV in Hypoxemic Patients

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