Preoxygenation Using NIV in Hypoxemic Patients (PREOXY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00472160
Recruitment Status : Completed
First Posted : May 11, 2007
Last Update Posted : March 28, 2011
Information provided by:
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment Phase
Critical Illness Hypoxemia Procedure: Non Invasive Ventilation Phase 4

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Preoxygenation Using Noninvasive Ventilation Prior Intubation in Hypoxemic Patients
Study Start Date : June 2007
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Arm Intervention/treatment
Experimental: 1
Non Invasive Ventilation
Procedure: Non Invasive Ventilation
Non Invasive Ventilation

Primary Outcome Measures :
  1. The maximum Sequential organ failure assessment (SOFA) score observed during the first week following endotracheal intubation. [ Time Frame: the first week ]

Secondary Outcome Measures :
  1. The mean drop in SpO2 during endotracheal intubation. [ Time Frame: during the intubation ]
  2. Number of organ failures (SOFA score >2) [ Time Frame: during the 7 days after intubation ]
  3. ICU length of stay [ Time Frame: during the stay in reanimation ]
  4. Mortality [ Time Frame: in reanimation ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adults patients with acute respiratory failure requiring intubation

Exclusion Criteria:

  • Encephalopathy or coma, cardiac resuscitation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00472160

Hopital de Bobigny
Bobigny, France, 93009
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Principal Investigator: Christophe BAILLARD, MD,PhD Assistance Publique - Hôpitaux de Paris

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Cecile JOURDAIN, Department Clinical Research of Developpement Identifier: NCT00472160     History of Changes
Other Study ID Numbers: P060230
First Posted: May 11, 2007    Key Record Dates
Last Update Posted: March 28, 2011
Last Verified: May 2007

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Non Invasive Ventilation
Continuous Positive Airway Pressure,
Organ failure

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes
Signs and Symptoms, Respiratory
Signs and Symptoms