Preoxygenation Using NIV in Hypoxemic Patients (PREOXY)

This study has been completed.
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00472160
First received: May 10, 2007
Last updated: March 25, 2011
Last verified: May 2007
  Purpose

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 Intervention Phase
Critical Illness
Hypoxemia
Procedure: Non Invasive Ventilation
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Preoxygenation Using Noninvasive Ventilation Prior Intubation in Hypoxemic Patients

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

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 ]

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 ]

Enrollment: 200
Study Start Date: June 2007
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Non Invasive Ventilation
Procedure: Non Invasive Ventilation
Non Invasive Ventilation
Other Name: Non Invasive Ventilation

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults patients with acute respiratory failure requiring intubation

Exclusion Criteria:

  • Encephalopathy or coma, cardiac resuscitation
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00472160

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

Publications:
Responsible Party: Cecile JOURDAIN, Department Clinical Research of Developpement
ClinicalTrials.gov Identifier: NCT00472160     History of Changes
Other Study ID Numbers: P060230
Study First Received: May 10, 2007
Last Updated: March 25, 2011
Health Authority: France: Ministry of Health

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

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

ClinicalTrials.gov processed this record on August 28, 2014