PREoxygenation for the Intubation of Hypoxemic Patients: Comparison of Standard Oxygenation, High Flow Nasal Oxygen Therapy, and NonInvasive Ventilation

Adult Patients Clinical Trial

— PREONIV  

Official title:

PREoxygenation for the Intubation of Hypoxemic Patients: Comparison of Standard Oxygenation, High Flow Nasal Oxygen Therapy, and NonInvasive Ventilation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01782430
• Other study ID #: CHU-0141
• Secondary ID: 2012-A00778-35
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: January 31, 2013
• Last updated: June 24, 2016
• Start date: April 2015
• Est. completion date: September 2016

Study information

• Verified date: June 2016
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 04 73 75 11 95
• Email: placarin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Prospective, randomized clinical multicentric study, in ICU, during preoxygenation for the intubation of hypoxemic patients.

Description:

Prospective randomized clinical multicentric study in ICU, comparing standard oxygenation, high flow nasal oxygen therapy and non invasive ventilation (NIV) , with pulse oxymetry values (SpO2), during preoxygenation for hypoxemic patients

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 132
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adults patients

• requiring intubation and hypoxemia (defined by PaO2/FiO2 below 200)

• patient covered by french health care system

Exclusion Criteria:

• patient refusal

• intubation for other causes (excluding hypoxemia)

• impossibility to measure pulse oxymetry value

• contraindication for NIV : vomiting

• NIV intolerance

• cardiac arrest during intubation

Study Design

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

Related Conditions & MeSH terms

• Adult Patients
• Hypoxemia (Defined by PaO2/FiO2( Fraction of Inspired Oxygen) Below 200)
• Patient Covered by French Health Care System
• Requiring Intubation

Intervention

Procedure:
• - standard oxygenation

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	Hopital Gabriel Montpied

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	least pulse oxymetry value		at day 1	No
Secondary	pulse oxymetry value (at the end of preoxygenation)		at 5 minutes and at 30 minutes after intubation	No
Secondary	Partial pressure of arterial oxygen (PaO2)		at day 1	No
Secondary	Regurgitation rate		at day 1	No
Secondary	oxyhemoglobin desaturation below 80 %		at day 1	No