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

NCT03632577 | Completed

• 1 other identifier: RC31/16/8769
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Disease

Keywords

High Flow Oxygen; Non Invasive Ventilation; Automated Flow Oxygen Titration; respiratory risk

Outcome Measures

Primary Outcomes (4)

• Primary outcome: Tolerance of each dispositive

  Comfort scale (from 0 to 100 : 0 is totally uncomfortable - 100 : comfortable)

  Hours 0

• Primary outcome: Tolerance of each dispositive

  Comfort scale (from 0 to 100 : 0 is totally uncomfortable - 100 : comfortable)

  Hours 6

• Primary outcome: Tolerance of each dispositive

  Comfort scale (from 0 to 100 : 0 is totally uncomfortable - 100 : comfortable)

  Hours 24

• Primary outcome: Tolerance of each dispositive

  Comfort scale (from 0 to 100 : 0 is totally uncomfortable - 100 : comfortable)

  Hours 48

Secondary Outcomes (18)

• Dyspnea scale of Borg

  Hours 6

• Dyspnea scale of Borg

  Hours 24

• Dyspnea scale of Borg

  Hours 48

• Treatment's failure defined as use of NVI in HFO group or use of HFO in NVI group

  Month 3

• Hematosis : PaO2, PaCO2, pH

  hours 6

Study Arms (2)

High Flow Oxygen (HFO)

EXPERIMENTAL

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)

Non Invasive Ventilation (NIV)

ACTIVE COMPARATOR

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)

Interventions

High Flow Oxygen (HFO) DEVICE

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.

High Flow Oxygen (HFO)

Non Invasive Ventilation (NIV) DEVICE

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.

Non Invasive Ventilation (NIV)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnant woman
• Terminal extubation
• Tracheotomy
• Patient under trusteeship, guardianship or safeguard of justice

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

CHU Larrey

Toulouse, 31049, France

Location

Related Publications (5)

• 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.

  PMID: 25592206 BACKGROUND

• 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.

  PMID: 19781896 BACKGROUND

• 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.

  PMID: 25558703 BACKGROUND

• 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.

  PMID: 25981908 BACKGROUND

• 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.

  PMID: 27706464 BACKGROUND

MeSH Terms

Conditions

Respiration Disorders

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Elise Noel-Savina, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2018
• First Posted: August 15, 2018
• Study Start: December 19, 2017
• Primary Completion: June 26, 2019
• Study Completion: October 15, 2019
• Last Updated: November 10, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)