Evaluation of Oxygen Therapy Delivery Systems in Hypoxemic Acute Respiratory Failure (OPTI O2)
Primary Purpose
Acute Respiratory Failure
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Oxygen therapy delivery systems
Sponsored by
About this trial
This is an interventional treatment trial for Acute Respiratory Failure focused on measuring Acute respiratory failure, Oxygen therapy delivery systems, Non invasive ventilation, High concentration mask, Hypoxemic pneumonia
Eligibility Criteria
Inclusion Criteria:
- Patient hospitalized in the intensive care unit of Nantes University Hospital
- Signed informed consent
- Patient with not hypercapnic acute hypoxemic respiratory failure
- Immunocompetent and immunodeficient patient
Exclusion Criteria:
- Age < 18 years
- Pregnancy
- Contra-indication to non invasive ventilation
- Allergy to xylocaine
- Coagulation troubles
- Tracheotomized patient
- Urgent indication to intubation
- Hypercapnic acute respiratory failure
- Acute pulmonary edema
- Face or nose malformation
Sites / Locations
- Nantes University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
VNI/Optiflow, Immunodeficient patients
Optiflow/VNI, Immunodeficient patients
Ospal/Optiflow, Immunocompetent patients
Optiflow/Ospal, Immunocompetent patients
Arm Description
VNI = non invasive ventilation
VNI = non invasive ventilation
Outcomes
Primary Outcome Measures
Calcul of the ratio PaO2/FiO2
The main objective of this study is to evaluate the efficiency of the oxygen therapy delivery system Optiflow® compared to 2 others standard oxygen therapy delivery systems (Ospal®, non invasive ventilation) by calculating the ratio PaO2/FiO2
Secondary Outcome Measures
number of participants with adverse events
The secondary outcomes are to understand the mechanisms of action of Optiflow system and to evaluate the tolerance of this system:
number of adverse events: respiratory events, trophic troubles, subjective events (comfort, dryness of mucous membranes, gastric distension, preferred system), serious hemodynamic and cardiovascular events
impact on work of breathing: measure of respiratory frequency and blood gas
measure of positive and expiratory pressure
measure of respiratory frequency and blood gas
The secondary outcomes are to understand the mechanisms of action of Optiflow system and to evaluate the tolerance of this system:
number of adverse events: respiratory events, trophic troubles, subjective events (comfort, dryness of mucous membranes, gastric distension, preferred system), serious hemodynamic and cardiovascular events
impact on work of breathing: measure of respiratory frequency and blood gas
measure of positive and expiratory pressure
measure of positive and expiratory pressure
The secondary outcomes are to understand the mechanisms of action of Optiflow system and to evaluate the tolerance of this system:
number of adverse events: respiratory events, trophic troubles, subjective events (comfort, dryness of mucous membranes, gastric distension, preferred system), serious hemodynamic and cardiovascular events
impact on work of breathing: measure of respiratory frequency and blood gas
measure of positive and expiratory pressure
Full Information
NCT ID
NCT01243918
First Posted
November 18, 2010
Last Updated
October 4, 2013
Sponsor
Nantes University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01243918
Brief Title
Evaluation of Oxygen Therapy Delivery Systems in Hypoxemic Acute Respiratory Failure
Acronym
OPTI O2
Official Title
Evaluation of Oxygen Therapy Delivery Systems in Hypoxemic Acute Respiratory Failure
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Terminated
Why Stopped
Difficulty of recruitment
Study Start Date
November 2010 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The main objective of this study is to evaluate the efficiency of the oxygen therapy delivery system Optiflow® compared to 2 others standard oxygen therapy delivery systems (Ospal®, non invasive ventilation).12 immunocompetent patients will compare the successive use of oxygen therapy delivery systems Optiflow®/Ospal® and 12 immunodeficient patients will compare the successive use of systems Optiflow®/Non invasive ventilation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Failure
Keywords
Acute respiratory failure, Oxygen therapy delivery systems, Non invasive ventilation, High concentration mask, Hypoxemic pneumonia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VNI/Optiflow, Immunodeficient patients
Arm Type
Experimental
Arm Description
VNI = non invasive ventilation
Arm Title
Optiflow/VNI, Immunodeficient patients
Arm Type
Experimental
Arm Description
VNI = non invasive ventilation
Arm Title
Ospal/Optiflow, Immunocompetent patients
Arm Type
Experimental
Arm Title
Optiflow/Ospal, Immunocompetent patients
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Oxygen therapy delivery systems
Intervention Description
T-60 (minutes) : clinical examination, blood gas, electrocardiogram; T0 / First oxygen therapy delivery system: clinical examination, blood gas, electrocardiogram, measurement of positive and expiratory pressure and FiO2; T10 : blood gas; Between T0 and T60 (every 10 minutes): clinical examination, measurement of positive and expiratory pressure and FiO2; T60 / Second oxygen therapy delivery system: clinical examination, blood gas, electrocardiogram, measurement of positive and expiratory pressure and FiO2; T70 : blood gas; Between T60 and T120 (every 10 minutes): clinical examination, measurement of positive and expiratory pressure and FiO2; T120: clinical examination, blood gas, electrocardiogram, measurement of positive and expiratory pressure and FiO2
Primary Outcome Measure Information:
Title
Calcul of the ratio PaO2/FiO2
Description
The main objective of this study is to evaluate the efficiency of the oxygen therapy delivery system Optiflow® compared to 2 others standard oxygen therapy delivery systems (Ospal®, non invasive ventilation) by calculating the ratio PaO2/FiO2
Time Frame
one hour after each system used
Secondary Outcome Measure Information:
Title
number of participants with adverse events
Description
The secondary outcomes are to understand the mechanisms of action of Optiflow system and to evaluate the tolerance of this system:
number of adverse events: respiratory events, trophic troubles, subjective events (comfort, dryness of mucous membranes, gastric distension, preferred system), serious hemodynamic and cardiovascular events
impact on work of breathing: measure of respiratory frequency and blood gas
measure of positive and expiratory pressure
Title
measure of respiratory frequency and blood gas
Description
The secondary outcomes are to understand the mechanisms of action of Optiflow system and to evaluate the tolerance of this system:
number of adverse events: respiratory events, trophic troubles, subjective events (comfort, dryness of mucous membranes, gastric distension, preferred system), serious hemodynamic and cardiovascular events
impact on work of breathing: measure of respiratory frequency and blood gas
measure of positive and expiratory pressure
Title
measure of positive and expiratory pressure
Description
The secondary outcomes are to understand the mechanisms of action of Optiflow system and to evaluate the tolerance of this system:
number of adverse events: respiratory events, trophic troubles, subjective events (comfort, dryness of mucous membranes, gastric distension, preferred system), serious hemodynamic and cardiovascular events
impact on work of breathing: measure of respiratory frequency and blood gas
measure of positive and expiratory pressure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient hospitalized in the intensive care unit of Nantes University Hospital
Signed informed consent
Patient with not hypercapnic acute hypoxemic respiratory failure
Immunocompetent and immunodeficient patient
Exclusion Criteria:
Age < 18 years
Pregnancy
Contra-indication to non invasive ventilation
Allergy to xylocaine
Coagulation troubles
Tracheotomized patient
Urgent indication to intubation
Hypercapnic acute respiratory failure
Acute pulmonary edema
Face or nose malformation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noëlle BRULE, Dr
Organizational Affiliation
Nantes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nantes University Hospital
City
Nantes
Country
France
12. IPD Sharing Statement
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Evaluation of Oxygen Therapy Delivery Systems in Hypoxemic Acute Respiratory Failure
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