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

Primary Purpose

Adult Patients, Requiring Intubation, Hypoxemia (Defined by PaO2/FiO2( Fraction of Inspired Oxygen) Below 200)

Status
Unknown status
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
- standard oxygenation
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adult Patients focused on measuring Preoxygenation, Intubation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Clermont-FerrandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

Standard oxygenation

High flow nasal oxygen therapy

invasive ventilation (VNI)

Arm 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

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

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

Outcomes

Primary Outcome Measures

least pulse oxymetry value

Secondary Outcome Measures

pulse oxymetry value (at the end of preoxygenation)
Partial pressure of arterial oxygen (PaO2)
Regurgitation rate
oxyhemoglobin desaturation below 80 %

Full Information

First Posted
January 31, 2013
Last Updated
June 24, 2016
Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Hopital Gabriel Montpied
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1. Study Identification

Unique Protocol Identification Number
NCT01782430
Brief Title
PREoxygenation for the Intubation of Hypoxemic Patients: Comparison of Standard Oxygenation, High Flow Nasal Oxygen Therapy, and NonInvasive Ventilation
Acronym
PREONIV
Official Title
PREoxygenation for the Intubation of Hypoxemic Patients: Comparison of Standard Oxygenation, High Flow Nasal Oxygen Therapy, and NonInvasive Ventilation
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2015 (undefined)
Primary Completion Date
September 2016 (Anticipated)
Study Completion Date
September 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Hopital Gabriel Montpied

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adult Patients, Requiring Intubation, Hypoxemia (Defined by PaO2/FiO2( Fraction of Inspired Oxygen) Below 200), Patient Covered by French Health Care System
Keywords
Preoxygenation, Intubation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
132 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard oxygenation
Arm Type
Experimental
Arm 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
Arm Title
High flow nasal oxygen therapy
Arm Type
Experimental
Arm 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
Arm Title
invasive ventilation (VNI)
Arm Type
Other
Arm 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
Intervention Type
Procedure
Intervention Name(s)
- standard oxygenation
Primary Outcome Measure Information:
Title
least pulse oxymetry value
Time Frame
at day 1
Secondary Outcome Measure Information:
Title
pulse oxymetry value (at the end of preoxygenation)
Time Frame
at 5 minutes and at 30 minutes after intubation
Title
Partial pressure of arterial oxygen (PaO2)
Time Frame
at day 1
Title
Regurgitation rate
Time Frame
at day 1
Title
oxyhemoglobin desaturation below 80 %
Time Frame
at day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick LACARIN
Phone
04 73 75 11 95
Email
placarin@chu-clermontferrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sébastien PERBET
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick LACARIN
Phone
04 73 75 11 95
Email
placarin@chu-clermontferrand.fr

12. IPD Sharing Statement

Learn more about this trial

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

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