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High Flow Oxygen VERSUS Non Invasive Ventilation Associated to Automated Flow Oxygen Titration After Patient Extubation (RespiFLOW)

Primary Purpose

Respiratory Disease

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
High Flow Oxygen (HFO)
Non Invasive Ventilation (NIV)
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Disease focused on measuring High Flow Oxygen, Non Invasive Ventilation, Automated Flow Oxygen Titration, respiratory risk

Eligibility Criteria

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

Inclusion Criteria:

  • Patient with respiratory disease suspected or proved (COPD, asthma, bronchiectasis, cystic fibrosis, interstitial pneumonia, obstructive insufficient respiratory, restrictive insufficient respiratory) when an extubation is scheduled.
  • Patient who signed the informed consent
  • Patient affiliated to social insurance

Exclusion Criteria:

  • Pregnant woman
  • Terminal extubation
  • NIV at home before intubation (non-exclusion of continue positive airway pressure: CPAP)
  • Tracheotomy
  • Patient under trusteeship, guardianship or safeguard of justice

Sites / Locations

  • CHU Larrey

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High Flow Oxygen (HFO)

Non Invasive Ventilation (NIV)

Arm Description

HFO is a mix tap of air and oxygen. It permits to control FiO2 and generated controlled high flow air until 60/min. Air and oxygen are mixed, warmed, humidified and issued to patient by a warming monopod inspiratory circuit to nasal cannulas of a large diameter. Expiration is free.

NIV was already evaluated in post-extubation. This technic is now used in daily consolidation processing after extubation because it provides a ventilator help with two levels of pressure helping in respiratory work. Adding Automated Flow Oxygen Titration could optimized patient's oxygenation and reduce workload of caregivers

Outcomes

Primary Outcome Measures

Primary outcome: Tolerance of each dispositive
Comfort scale (from 0 to 100 : 0 is totally uncomfortable - 100 : comfortable)
Primary outcome: Tolerance of each dispositive
Comfort scale (from 0 to 100 : 0 is totally uncomfortable - 100 : comfortable)
Primary outcome: Tolerance of each dispositive
Comfort scale (from 0 to 100 : 0 is totally uncomfortable - 100 : comfortable)
Primary outcome: Tolerance of each dispositive
Comfort scale (from 0 to 100 : 0 is totally uncomfortable - 100 : comfortable)

Secondary Outcome Measures

Dyspnea scale of Borg
Dyspnea score which is a quantitative measure of the perception of effort during a physical exercise. The measure is a rating on a scale from 0 to 10 attached to different words of appreciation: "very light, difficult, painful ..." effort. This global measurement, based on the physical and psychological sensations of the person, takes into account the physical condition, the environmental conditions and the level of general fatigue. The scale between 0 and 10 was designed to approximate the heart rate of a healthy young adult (effort 8 represents 80% of the CF).
Dyspnea scale of Borg
Dyspnea score which is a quantitative measure of the perception of effort during a physical exercise. The measure is a rating on a scale from 0 to 10 attached to different words of appreciation: "very light, difficult, painful ..." effort. This global measurement, based on the physical and psychological sensations of the person, takes into account the physical condition, the environmental conditions and the level of general fatigue. The scale between 0 and 10 was designed to approximate the heart rate of a healthy young adult (effort 8 represents 80% of the CF).
Dyspnea scale of Borg
Dyspnea score which is a quantitative measure of the perception of effort during a physical exercise. The measure is a rating on a scale from 0 to 10 attached to different words of appreciation: "very light, difficult, painful ..." effort. This global measurement, based on the physical and psychological sensations of the person, takes into account the physical condition, the environmental conditions and the level of general fatigue. The scale between 0 and 10 was designed to approximate the heart rate of a healthy young adult (effort 8 represents 80% of the CF).
Treatment's failure defined as use of NVI in HFO group or use of HFO in NVI group
defined by reintubation or exchange of treatment or premature discontinuation of treatment
Hematosis : PaO2, PaCO2, pH
Measurement of PaO2, PaCO2 and pH
Hematosis : PaO2, PaCO2, pH
Measurement of PaO2, PaCO2 and pH
Hematosis : PaO2, PaCO2, pH
Measurement of PaO2, PaCO2 and pH
Duration of hospitalization in intensive care units, reanimation, hospital after extubation.
Measurement of hospitalization in intensive care units in days
Mortality in ICU (continuous monitoring unit)
Measurement of mortality
Mortality in hospital
Measurement of mortality
Mortality at M1 and M3
Measurement of mortality
Mortality at M1 and M3
Measurement of mortality
Use of another technic (HFO or NVI) in time
Duration of use of the device (VNI, OHD) at H72
Respiratory congestion (number of fibroscopy for airway's desobstruction, number of respiratory kinesitherapy consults, radiological atelectasis)
Measurement of respiratory congestion by : number of fibroscopy for airway's desobstruction, number of respiratory kinesitherapy consults and radiological atelectasis
New intubation rate at H48
New intubation rate at H48
New intubation rate at H72
New intubation rate at H72
SpO2 stability
Percentage of time spent below 88% and above 92% of SpO2
SpO2 stability
Percentage of time spent below 88% and above 92% of SpO2

Full Information

First Posted
March 25, 2018
Last Updated
November 9, 2020
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT03632577
Brief Title
High Flow Oxygen VERSUS Non Invasive Ventilation Associated to Automated Flow Oxygen Titration After Patient Extubation
Acronym
RespiFLOW
Official Title
High Flow Oxygen (HFO) VERSUS Non Invasive Ventilation (NIV) Associated to Automated Flow Oxygen Titration (AFOT) After Extubation in Patient With Respiratory Risk: Non-inferiority Prospective Comparative Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
December 19, 2017 (Actual)
Primary Completion Date
June 26, 2019 (Actual)
Study Completion Date
October 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Extubation stay at high risk of reintubation even scheduled and in the best condition of hematosis. Re-intubation's rate in main studies in chronic obstructive diseases reach to 20% and it is associated to a higher mortality, higher pneumonia under mechanic ventilation, and higher duration of hospitalization especially in intensive care units. Place of NIV in this situation is still on evaluation. A recent meta-analysis demonstrates that use of NIV in post-extubation in COPD seems to decrease re-intubation rate. HFO, thanks to its properties (oxygen, humidification and heat with high flow) could be useful in this population in ventilatory weaning. Compared to oxygen conventional therapy with high-concentration mask, HFO seems to be as efficient and better tolerated. A recent study shows that HFO is non-inferior to NVI in post-extubation in patient with high risk of re-intubation. Furthermore, oxygenation in post-extubation should be optimized to avoid hypoxemia and hypercapnia in this patient at risk of hypoventilation. Place of AFOT could improve hematosis by providing adapted flow of oxygen to each patient. The investigator choose the hypothesis for this study that HFO is as effective and tolerated in post-extubation than NIV with AFOT.
Detailed Description
A recent meta-analysis demonstrates that use of NIV in post-extubation in obstructive chronic bronchopathies seems to decrease re-intubation rate. High Flow Oxygen, thanks to its properties (oxygen, humidification and heat with high flow) could be useful in this population in ventilatory weaning. Compared to oxygen conventional therapy with high-concentration mask, High Flow Oxygen seems to be as efficient and better tolerated . A recent study shows that High Flow Oxygen is non-inferior to Non Invasive Ventilation in post-extubation in patient with high risk of re-intubation. Furthermore, oxygenation in post-extubation should be optimized to avoid hypoxemia and hypercapnia in this patient at risk of hypoventilation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Disease
Keywords
High Flow Oxygen, Non Invasive Ventilation, Automated Flow Oxygen Titration, respiratory risk

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High Flow Oxygen (HFO)
Arm Type
Experimental
Arm Description
HFO is a mix tap of air and oxygen. It permits to control FiO2 and generated controlled high flow air until 60/min. Air and oxygen are mixed, warmed, humidified and issued to patient by a warming monopod inspiratory circuit to nasal cannulas of a large diameter. Expiration is free.
Arm Title
Non Invasive Ventilation (NIV)
Arm Type
Active Comparator
Arm Description
NIV was already evaluated in post-extubation. This technic is now used in daily consolidation processing after extubation because it provides a ventilator help with two levels of pressure helping in respiratory work. Adding Automated Flow Oxygen Titration could optimized patient's oxygenation and reduce workload of caregivers
Intervention Type
Device
Intervention Name(s)
High Flow Oxygen (HFO)
Intervention Description
HFO is a mix tap of air and oxygen. It permits to control FiO2 and generated controlled high flow air until 60/min. Air and oxygen are mixed, warmed, humidified and issued to patient by a warming monopod inspiratory circuit to nasal cannulas of a large diameter. Expiration is free.
Intervention Type
Device
Intervention Name(s)
Non Invasive Ventilation (NIV)
Intervention Description
NIV was already evaluated in post-extubation. This technic is now used in daily consolidation processing after extubation because it provides a ventilator help with two levels of pressure helping in respiratory work. Adding Automated Flow Oxygen Titration could optimized patient's oxygenation and reduce workload of caregivers.
Primary Outcome Measure Information:
Title
Primary outcome: Tolerance of each dispositive
Description
Comfort scale (from 0 to 100 : 0 is totally uncomfortable - 100 : comfortable)
Time Frame
Hours 0
Title
Primary outcome: Tolerance of each dispositive
Description
Comfort scale (from 0 to 100 : 0 is totally uncomfortable - 100 : comfortable)
Time Frame
Hours 6
Title
Primary outcome: Tolerance of each dispositive
Description
Comfort scale (from 0 to 100 : 0 is totally uncomfortable - 100 : comfortable)
Time Frame
Hours 24
Title
Primary outcome: Tolerance of each dispositive
Description
Comfort scale (from 0 to 100 : 0 is totally uncomfortable - 100 : comfortable)
Time Frame
Hours 48
Secondary Outcome Measure Information:
Title
Dyspnea scale of Borg
Description
Dyspnea score which is a quantitative measure of the perception of effort during a physical exercise. The measure is a rating on a scale from 0 to 10 attached to different words of appreciation: "very light, difficult, painful ..." effort. This global measurement, based on the physical and psychological sensations of the person, takes into account the physical condition, the environmental conditions and the level of general fatigue. The scale between 0 and 10 was designed to approximate the heart rate of a healthy young adult (effort 8 represents 80% of the CF).
Time Frame
Hours 6
Title
Dyspnea scale of Borg
Description
Dyspnea score which is a quantitative measure of the perception of effort during a physical exercise. The measure is a rating on a scale from 0 to 10 attached to different words of appreciation: "very light, difficult, painful ..." effort. This global measurement, based on the physical and psychological sensations of the person, takes into account the physical condition, the environmental conditions and the level of general fatigue. The scale between 0 and 10 was designed to approximate the heart rate of a healthy young adult (effort 8 represents 80% of the CF).
Time Frame
Hours 24
Title
Dyspnea scale of Borg
Description
Dyspnea score which is a quantitative measure of the perception of effort during a physical exercise. The measure is a rating on a scale from 0 to 10 attached to different words of appreciation: "very light, difficult, painful ..." effort. This global measurement, based on the physical and psychological sensations of the person, takes into account the physical condition, the environmental conditions and the level of general fatigue. The scale between 0 and 10 was designed to approximate the heart rate of a healthy young adult (effort 8 represents 80% of the CF).
Time Frame
Hours 48
Title
Treatment's failure defined as use of NVI in HFO group or use of HFO in NVI group
Description
defined by reintubation or exchange of treatment or premature discontinuation of treatment
Time Frame
Month 3
Title
Hematosis : PaO2, PaCO2, pH
Description
Measurement of PaO2, PaCO2 and pH
Time Frame
hours 6
Title
Hematosis : PaO2, PaCO2, pH
Description
Measurement of PaO2, PaCO2 and pH
Time Frame
hours 24
Title
Hematosis : PaO2, PaCO2, pH
Description
Measurement of PaO2, PaCO2 and pH
Time Frame
hours 48
Title
Duration of hospitalization in intensive care units, reanimation, hospital after extubation.
Description
Measurement of hospitalization in intensive care units in days
Time Frame
Month 3
Title
Mortality in ICU (continuous monitoring unit)
Description
Measurement of mortality
Time Frame
Month 3
Title
Mortality in hospital
Description
Measurement of mortality
Time Frame
Month 3
Title
Mortality at M1 and M3
Description
Measurement of mortality
Time Frame
Month 1
Title
Mortality at M1 and M3
Description
Measurement of mortality
Time Frame
Month 3
Title
Use of another technic (HFO or NVI) in time
Description
Duration of use of the device (VNI, OHD) at H72
Time Frame
hours 72
Title
Respiratory congestion (number of fibroscopy for airway's desobstruction, number of respiratory kinesitherapy consults, radiological atelectasis)
Description
Measurement of respiratory congestion by : number of fibroscopy for airway's desobstruction, number of respiratory kinesitherapy consults and radiological atelectasis
Time Frame
month 3
Title
New intubation rate at H48
Description
New intubation rate at H48
Time Frame
Hours 48
Title
New intubation rate at H72
Description
New intubation rate at H72
Time Frame
Hours 72
Title
SpO2 stability
Description
Percentage of time spent below 88% and above 92% of SpO2
Time Frame
hours 48
Title
SpO2 stability
Description
Percentage of time spent below 88% and above 92% of SpO2
Time Frame
hours 72

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient with respiratory disease suspected or proved (COPD, asthma, bronchiectasis, cystic fibrosis, interstitial pneumonia, obstructive insufficient respiratory, restrictive insufficient respiratory) when an extubation is scheduled. Patient who signed the informed consent Patient affiliated to social insurance Exclusion Criteria: Pregnant woman Terminal extubation NIV at home before intubation (non-exclusion of continue positive airway pressure: CPAP) Tracheotomy Patient under trusteeship, guardianship or safeguard of justice
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elise Noel-Savina, MD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Larrey
City
Toulouse
ZIP/Postal Code
31049
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25592206
Citation
Bajaj A, Rathor P, Sehgal V, Shetty A. Efficacy of noninvasive ventilation after planned extubation: A systematic review and meta-analysis of randomized controlled trials. Heart Lung. 2015 Mar-Apr;44(2):150-7. doi: 10.1016/j.hrtlng.2014.12.002. Epub 2015 Jan 13.
Results Reference
background
PubMed Identifier
19781896
Citation
Tiruvoipati R, Lewis D, Haji K, Botha J. High-flow nasal oxygen vs high-flow face mask: a randomized crossover trial in extubated patients. J Crit Care. 2010 Sep;25(3):463-8. doi: 10.1016/j.jcrc.2009.06.050. Epub 2009 Sep 24.
Results Reference
background
PubMed Identifier
25558703
Citation
Brotfain E, Zlotnik A, Schwartz A, Frenkel A, Koyfman L, Gruenbaum SE, Klein M. Comparison of the effectiveness of high flow nasal oxygen cannula vs. standard non-rebreather oxygen face mask in post-extubation intensive care unit patients. Isr Med Assoc J. 2014 Nov;16(11):718-22.
Results Reference
background
PubMed Identifier
25981908
Citation
Frat JP, Thille AW, Mercat A, Girault C, Ragot S, Perbet S, Prat G, Boulain T, Morawiec E, Cottereau A, Devaquet J, Nseir S, Razazi K, Mira JP, Argaud L, Chakarian JC, Ricard JD, Wittebole X, Chevalier S, Herbland A, Fartoukh M, Constantin JM, Tonnelier JM, Pierrot M, Mathonnet A, Beduneau G, Deletage-Metreau C, Richard JC, Brochard L, Robert R; FLORALI Study Group; REVA Network. High-flow oxygen through nasal cannula in acute hypoxemic respiratory failure. N Engl J Med. 2015 Jun 4;372(23):2185-96. doi: 10.1056/NEJMoa1503326. Epub 2015 May 17.
Results Reference
background
PubMed Identifier
27706464
Citation
Hernandez G, Vaquero C, Colinas L, Cuena R, Gonzalez P, Canabal A, Sanchez S, Rodriguez ML, Villasclaras A, Fernandez R. Effect of Postextubation High-Flow Nasal Cannula vs Noninvasive Ventilation on Reintubation and Postextubation Respiratory Failure in High-Risk Patients: A Randomized Clinical Trial. JAMA. 2016 Oct 18;316(15):1565-1574. doi: 10.1001/jama.2016.14194. Erratum In: JAMA. 2016 Nov 15;316(19):2047-2048. JAMA. 2017 Feb 28;317(8):858.
Results Reference
background

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High Flow Oxygen VERSUS Non Invasive Ventilation Associated to Automated Flow Oxygen Titration After Patient Extubation

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