Preoxygenation Using NIV in Hypoxemic Patients

Phase 4

Completed

• Conditions: Critical Illness; Hypoxemia
• Interventions: Procedure: Non Invasive Ventilation

• Registration Number: NCT00472160
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2007-05
• Study First Submitted: 2007-05-10
• Study First Submitted QC: 2007-05-10
• Study First Posted: 2007-05-11
• Study Start: 2007-06
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Last Update Submitted: 2011-03-25
• Last Update Posted: 2011-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Adults patients with acute respiratory failure requiring intubation

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Exclusion Criteria

• Encephalopathy or coma, cardiac resuscitation

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Non Invasive Ventilation	Non Invasive Ventilation

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hopital de Bobigny; 🇫🇷 Bobigny, France