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Clinical Trials/NCT00472160
NCT00472160
Completed
Phase 4

Preoxygenation Using Noninvasive Ventilation Prior Intubation in Hypoxemic Patients

Assistance Publique - Hôpitaux de Paris1 site in 1 country200 target enrollmentJune 2007

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Critical Illness
Sponsor
Assistance Publique - Hôpitaux de Paris
Enrollment
200
Locations
1
Primary Endpoint
The maximum Sequential organ failure assessment (SOFA) score observed during the first week following endotracheal intubation.
Status
Completed
Last Updated
15 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2007
End Date
June 2010
Last Updated
15 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Adults patients with acute respiratory failure requiring intubation

Exclusion Criteria

  • Encephalopathy or coma, cardiac resuscitation

Outcomes

Primary Outcomes

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

Time Frame: the first week

Secondary Outcomes

  • The mean drop in SpO2 during endotracheal intubation.(during the intubation)
  • Mortality(in reanimation)
  • Number of organ failures (SOFA score >2)(during the 7 days after intubation)
  • ICU length of stay(during the stay in reanimation)

Study Sites (1)

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