PREoxygenation for the Intubation of Hypoxemic Patients: Comparison of Standard Oxygenation, High Flow Nasal Oxygen Therapy, and NonInvasive Ventilation (PREONIV)
This study is not yet open for participant recruitment.
Verified January 2013 by University Hospital, Clermont-Ferrand
Sponsor:
University Hospital, Clermont-Ferrand
Collaborator:
ICU, University Hospital Gabriel-Montpied, CHU Clermont-FD, France
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT01782430
First received: January 31, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
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Purpose
Prospective, randomized clinical multicentric study, in ICU, during preoxygenation for the intubation of hypoxemic patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Adult Patients Requiring Intubation Hypoxemia (Defined by PaO2/FiO2( Fraction of Inspired Oxygen) Below 200) Patient Covered by French Health Care System |
Procedure: - standard oxygenation |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | PREoxygenation for the Intubation of Hypoxemic Patients: Comparison of Standard Oxygenation, High Flow Nasal Oxygen Therapy, and NonInvasive Ventilation |
Resource links provided by NLM:
Further study details as provided by University Hospital, Clermont-Ferrand:
Primary Outcome Measures:
- least pulse oxymetry value [ Time Frame: at day 1 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- pulse oxymetry value (at the end of preoxygenation) [ Time Frame: at 5 minutes and at 30 minutes after intubation ] [ Designated as safety issue: No ]
- Partial pressure of arterial oxygen (PaO2) [ Time Frame: at day 1 ] [ Designated as safety issue: No ]
- Regurgitation rate [ Time Frame: at day 1 ] [ Designated as safety issue: No ]
- oxyhemoglobin desaturation below 80 % [ Time Frame: at day 1 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 144 |
| Study Start Date: | April 2013 |
| Estimated Study Completion Date: | June 2015 |
| Estimated Primary Completion Date: | May 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Standard oxygenation
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
|
Procedure: - standard oxygenation |
|
Experimental: High flow nasal oxygen therapy
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
|
Procedure: - standard oxygenation |
|
invasive ventilation (VNI)
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
|
Procedure: - standard oxygenation |
Detailed 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
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01782430
Contacts
| Contact: Patrick LACARIN | 04 73 75 11 95 | placarin@chu-clermontferrand.fr |
Locations
| France | |
| CHU Clermont-Ferrand | Not yet recruiting |
| Clermont-Ferrand, France, 63003 | |
| Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr | |
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
ICU, University Hospital Gabriel-Montpied, CHU Clermont-FD, France
Investigators
| Principal Investigator: | Sébastien PERBET | University Hospital, Clermont-Ferrand |
More Information
No publications provided
| Responsible Party: | University Hospital, Clermont-Ferrand |
| ClinicalTrials.gov Identifier: | NCT01782430 History of Changes |
| Other Study ID Numbers: | CHU-0141, 2012-A00778-35 |
| Study First Received: | January 31, 2013 |
| Last Updated: | January 31, 2013 |
| Health Authority: | France: Ministry of Health |
Keywords provided by University Hospital, Clermont-Ferrand:
|
Preoxygenation Intubation |
ClinicalTrials.gov processed this record on May 22, 2013