Preoxygenation Using NIV in Hypoxemic Patients

Critical Illness Clinical Trial

— PREOXY  

Official title:

Preoxygenation Using Noninvasive Ventilation Prior Intubation in Hypoxemic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00472160
• Other study ID #: P060230
• Status: Completed
• Phase: Phase 4
• First received: May 10, 2007
• Last updated: March 25, 2011
• Start date: June 2007
• Est. completion date: June 2010

Study information

• Verified date: May 2007
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults patients with acute respiratory failure requiring intubation

Exclusion Criteria:

• Encephalopathy or coma, cardiac resuscitation

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Critical Illness
• Hypoxemia

Intervention

Procedure:
• Non Invasive Ventilation
Non Invasive Ventilation

Locations

Country	Name	City	State
France	Hopital de Bobigny	Bobigny

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (1)

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. Epub 20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The maximum Sequential organ failure assessment (SOFA) score observed during the first week following endotracheal intubation.		the first week	No
Secondary	The mean drop in SpO2 during endotracheal intubation.		during the intubation	Yes
Secondary	Number of organ failures (SOFA score >2)		during the 7 days after intubation	Yes
Secondary	ICU length of stay		during the stay in reanimation	Yes
Secondary	Mortality		in reanimation	No