- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01782430
PREoxygenation for the Intubation of Hypoxemic Patients: Comparison of Standard Oxygenation, High Flow Nasal Oxygen Therapy, and NonInvasive Ventilation (PREONIV)
June 24, 2016 updated by: University Hospital, Clermont-Ferrand
Prospective, randomized clinical multicentric study, in ICU, during preoxygenation for the intubation of hypoxemic patients.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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
Study Type
Interventional
Enrollment (Anticipated)
132
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Clermont-Ferrand, France, 63003
- Recruiting
- Chu Clermont-Ferrand
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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
|
|
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
|
|
Other: 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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
least pulse oxymetry value
Time Frame: at day 1
|
at day 1
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Partial pressure of arterial oxygen (PaO2)
Time Frame: at day 1
|
at day 1
|
Regurgitation rate
Time Frame: at day 1
|
at day 1
|
oxyhemoglobin desaturation below 80 %
Time Frame: at day 1
|
at day 1
|
pulse oxymetry value (at the end of preoxygenation)
Time Frame: at 5 minutes and at 30 minutes after intubation
|
at 5 minutes and at 30 minutes after intubation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2015
Primary Completion (Anticipated)
September 1, 2016
Study Completion (Anticipated)
September 1, 2016
Study Registration Dates
First Submitted
January 31, 2013
First Submitted That Met QC Criteria
January 31, 2013
First Posted (Estimate)
February 1, 2013
Study Record Updates
Last Update Posted (Estimate)
June 27, 2016
Last Update Submitted That Met QC Criteria
June 24, 2016
Last Verified
June 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHU-0141
- 2012-A00778-35 (Registry Identifier: 2012-A00778-35)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Adult Patients
-
Indonesia UniversityCompletedAdult Patients Undergoing ERCPIndonesia
-
University of ArizonaUnknown
-
Govind Ballabh Pant HospitalCompletedAdult Cardiac Surgical PatientsIndia
-
Hospital Ernesto DornellesFederal University of Rio Grande do Sul; Hospital Moinhos de VentoUnknownDifficult-to-wean Adult PatientsBrazil
-
Centre Francois BaclesseCureetyRecruitingAdult Patients Initiating Injectable AnticancerFrance
-
Poitiers University HospitalCompletedMajor Surgery in Adult PatientsFrance
-
Jiangsu HengRui Medicine Co., Ltd.Not yet recruitingAdult Patients With Chronic Primary ITP | Adult Patients With SAA Who do Not Respond Well to Immunosuppressive TherapyChina
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI); Memorial Sloan Kettering Cancer Center; University... and other collaboratorsRecruitingCancer Patients | Supportive Care | Young AdultUnited States
-
Jiangsu HengRui Medicine Co., Ltd.Not yet recruitingAdult Patients With Chronic Primary ITP | Adult Patients With SAA Who do Not Respond Well to Immunosuppressive Therapy
-
University Hospital, Clermont-FerrandHospices Civils de Lyon; Centre Hospitalier Universitaire de Saint Etienne; University... and other collaboratorsCompletedAdult Patients Ventilated More Than 48 hFrance
Clinical Trials on - standard oxygenation
-
University Hospital, Clermont-FerrandUnknownAdult Patients | Patient Covered by French Health Care System | Requiring Intubation | Hypoxemia (Defined by PaO2/FiO2( Fraction of Inspired Oxygen) Below 200)France
-
University Hospital, BrestRecruitingChest Trauma | High Flow OxygenationFrance
-
University of PennsylvaniaEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsRecruitingTracheal Intubation Morbidity | Neonatal Respiratory FailureUnited States
-
Dr. Negrin University HospitalAsociación Científica Pulmón y Ventilación MecánicaCompleted
-
University of PadovaPerforma di Crocicchia SrlCompleted
-
University of RijekaRecruitingQuality of Life | Chronic Pain | Wound | Wound Healing | BiofilmCroatia
-
Great Ormond Street Hospital for Children NHS Foundation...University College, London; University of Southampton; University Hospital Southampton... and other collaboratorsCompletedHypoxia | Pediatric ALL | Critical CareUnited Kingdom
-
University Health Network, TorontoCompleted
-
Hadassah Medical OrganizationUnknownComplication of Coronary Artery Bypass Graft
-
University of MinnesotaTerminatedVentricular Fibrillation | Cardiac Arrest | Out-Of-Hospital Cardiac Arrest | Extracorporeal Membrane Oxygenation Complication | Pulseless Ventricular TachycardiaUnited States