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

Sponsor

University Hospital, Toulouse (Other)

Overall Status

Completed

CT.gov ID

NCT03632577

Collaborator

(none)

Enrollment

Location

Arms

21.8

Actual Duration (Months)

2.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Disease	Device: High Flow Oxygen (HFO) Device: Non Invasive Ventilation (NIV)	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

55 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Dec 19, 2017

Actual Primary Completion Date :

Jun 26, 2019

Actual Study Completion Date :

Oct 15, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: High Flow Oxygen (HFO) 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.	Device: High Flow Oxygen (HFO) 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.
Active Comparator: Non Invasive Ventilation (NIV) 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	Device: Non Invasive Ventilation (NIV) 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.

Arm

Intervention/Treatment

Experimental: High Flow Oxygen (HFO)

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.

Device: High Flow Oxygen (HFO)

Active Comparator: Non Invasive Ventilation (NIV)

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

Device: Non Invasive Ventilation (NIV)

Outcome Measures

Primary Outcome Measures

Primary outcome: Tolerance of each dispositive [Hours 0]
Comfort scale (from 0 to 100 : 0 is totally uncomfortable - 100 : comfortable)
Primary outcome: Tolerance of each dispositive [Hours 6]
Comfort scale (from 0 to 100 : 0 is totally uncomfortable - 100 : comfortable)
Primary outcome: Tolerance of each dispositive [Hours 24]
Comfort scale (from 0 to 100 : 0 is totally uncomfortable - 100 : comfortable)
Primary outcome: Tolerance of each dispositive [Hours 48]
Comfort scale (from 0 to 100 : 0 is totally uncomfortable - 100 : comfortable)

Secondary Outcome Measures

Dyspnea scale of Borg [Hours 6]
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 [Hours 24]
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 [Hours 48]
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 [Month 3]
defined by reintubation or exchange of treatment or premature discontinuation of treatment
Hematosis : PaO2, PaCO2, pH [hours 6]
Measurement of PaO2, PaCO2 and pH
Hematosis : PaO2, PaCO2, pH [hours 24]
Measurement of PaO2, PaCO2 and pH
Hematosis : PaO2, PaCO2, pH [hours 48]
Measurement of PaO2, PaCO2 and pH
Duration of hospitalization in intensive care units, reanimation, hospital after extubation. [Month 3]
Measurement of hospitalization in intensive care units in days
Mortality in ICU (continuous monitoring unit) [Month 3]
Measurement of mortality
Mortality in hospital [Month 3]
Measurement of mortality
Mortality at M1 and M3 [Month 1]
Measurement of mortality
Mortality at M1 and M3 [Month 3]
Measurement of mortality
Use of another technic (HFO or NVI) in time [hours 72]
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) [month 3]
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 [Hours 48]
New intubation rate at H48
New intubation rate at H72 [Hours 72]
New intubation rate at H72
SpO2 stability [hours 48]
Percentage of time spent below 88% and above 92% of SpO2
SpO2 stability [hours 72]
Percentage of time spent below 88% and above 92% of SpO2

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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