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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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4 July 2016 |
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Main ID: |
NCT01782430 |
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Date of registration:
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31/01/2013 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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PREoxygenation for the Intubation of Hypoxemic Patients: Comparison of Standard Oxygenation, High Flow Nasal Oxygen Therapy, and NonInvasive Ventilation
PREONIV |
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Scientific title:
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PREoxygenation for the Intubation of Hypoxemic Patients: Comparison of Standard Oxygenation, High Flow Nasal Oxygen Therapy, and NonInvasive Ventilation |
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Date of first enrolment:
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April 2015 |
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Target sample size:
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132 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT01782430 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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France
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Contacts
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Name:
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Patrick LACARIN |
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Address:
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Telephone:
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04 73 75 11 95 |
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Email:
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placarin@chu-clermontferrand.fr |
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Affiliation:
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Name:
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Patrick LACARIN |
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Address:
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Telephone:
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04 73 75 11 95 |
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Email:
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placarin@chu-clermontferrand.fr |
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Affiliation:
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Name:
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Sébastien PERBET |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital, Clermont-Ferrand |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hypoxemia (Defined by PaO2/FiO2( Fraction of Inspired Oxygen) Below 200)
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Requiring Intubation
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Adult Patients
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Patient Covered by French Health Care System
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Intervention(s)
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Procedure: - standard oxygenation
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Primary Outcome(s)
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least pulse oxymetry value
[Time Frame: at day 1]
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Secondary Outcome(s)
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oxyhemoglobin desaturation below 80 %
[Time Frame: at day 1]
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Partial pressure of arterial oxygen (PaO2)
[Time Frame: at day 1]
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pulse oxymetry value (at the end of preoxygenation)
[Time Frame: at 5 minutes and at 30 minutes after intubation]
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Regurgitation rate
[Time Frame: at day 1]
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Secondary ID(s)
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2012-A00778-35
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CHU-0141
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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