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

Not Applicable

Completed

• Conditions: Respiratory Disease

• Registration Number: NCT03632577
• Lead Sponsor: University Hospital, Toulouse

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.

Study Timeline

• Study Start: 2017-12-19
• Study First Submitted: 2018-03-25
• Study First Submitted QC: 2018-08-13
• Study First Posted: 2018-08-15
• Primary Completion: 2019-06-26
• Study Completion: 2019-10-15
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-09
• Last Update Posted: 2020-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Primary outcome: Tolerance of each dispositive	Hours 48	Comfort scale (from 0 to 100 : 0 is totally uncomfortable - 100 : comfortable)

Secondary Outcome Measures

Name	Time	Method
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 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 hospital	Month 3	Measurement of mortality
Mortality in ICU (continuous monitoring unit)	Month 3	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 72	Percentage of time spent below 88% and above 92% of SpO2

Trial Locations

Locations (1)

CHU Larrey; 🇫🇷 Toulouse, France