Clinical trial NCT03632577: High Flow Oxygen VERSUS Non Invasive Ventilation Associated to Automated Flow Oxygen Titration After Patient Extubation
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
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Disease
Keywords: High Flow Oxygen
Non Invasive Ventilation
Automated Flow Oxygen Titration
respiratory risk
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2018-08-15
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Primary outcome: Tolerance of each dispositive
timeFrame: Hours 0
measure: Primary outcome: Tolerance of each dispositive
timeFrame: Hours 6
measure: Primary outcome: Tolerance of each dispositive
timeFrame: Hours 24
measure: Primary outcome: Tolerance of each dispositive
timeFrame: Hours 48
Secondary outcomes:
measure: Dyspnea scale of Borg
timeFrame: Hours 6
measure: Dyspnea scale of Borg
timeFrame: Hours 24
measure: Dyspnea scale of Borg
timeFrame: Hours 48
measure: Treatment's failure defined as use of NVI in HFO group or use of HFO in NVI group
timeFrame: Month 3
measure: Hematosis : PaO2, PaCO2, pH
timeFrame: hours 6
measure: Hematosis : PaO2, PaCO2, pH
timeFrame: hours 24
measure: Hematosis : PaO2, PaCO2, pH
timeFrame: hours 48
measure: Duration of hospitalization in intensive care units, reanimation, hospital after extubation.
timeFrame: Month 3
measure: Mortality in ICU (continuous monitoring unit)
timeFrame: Month 3
measure: Mortality in hospital
timeFrame: Month 3
measure: Mortality at M1 and M3
timeFrame: Month 1
measure: Mortality at M1 and M3
timeFrame: Month 3
measure: Use of another technic (HFO or NVI) in time
timeFrame: hours 72
measure: Respiratory congestion (number of fibroscopy for airway's desobstruction, number of respiratory kinesitherapy consults, radiological atelectasis)
timeFrame: month 3
measure: New intubation rate at H48
timeFrame: Hours 48
measure: New intubation rate at H72
timeFrame: Hours 72
measure: SpO2 stability
timeFrame: hours 48
measure: SpO2 stability
timeFrame: hours 72
Other outcomes:
Locations:
city: Toulouse
country: France
facility: CHU Larrey
Study officials:
affiliation: University Hospital, Toulouse
name: Elise Noel-Savina, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.