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

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

Sponsors

Lead Sponsor: University Hospital, Toulouse

Source 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.

Overall Status Unknown status
Start Date December 19, 2017
Completion Date March 19, 2020
Primary Completion Date December 19, 2019
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Primary outcome: Tolerance of each dispositive Hours 0
Primary outcome: Tolerance of each dispositive Hours 6
Primary outcome: Tolerance of each dispositive Hours 24
Primary outcome: Tolerance of each dispositive Hours 48
Secondary Outcome
Measure Time Frame
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
Hematosis : PaO2, PaCO2, pH hours 24
Hematosis : PaO2, PaCO2, pH hours 48
Duration of hospitalization in intensive care units, reanimation, hospital after extubation. Month 3
Mortality in ICU (continuous monitoring unit) Month 3
Mortality in hospital Month 3
Mortality at M1 and M3 Month 1
Mortality at M1 and M3 Month 3
Use of another technic (HFO or NVI) in time hours 72
Respiratory congestion (number of fibroscopy for airway's desobstruction, number of respiratory kinesitherapy consults, radiological atelectasis) month 3
New intubation rate at H48 Hours 48
New intubation rate at H72 Hours 72
SpO2 stability hours 48
SpO2 stability hours 72
Enrollment 60
Condition
Intervention

Intervention Type: Device

Intervention Name: High Flow Oxygen (HFO)

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 Group Label: High Flow Oxygen (HFO)

Intervention Type: Device

Intervention Name: Non Invasive Ventilation (NIV)

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.

Arm Group Label: Non Invasive Ventilation (NIV)

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Elise Noel-Savina, MD Principal Investigator University Hospital, Toulouse
Overall Contact

Last Name: Elise Noel-Savina, MD

Phone: 5 67 77 16 90

Phone Ext.: 33

Email: [email protected]

Location
Facility: Status: Contact: Investigator: CHU Larrey Elise Noel-Savina, MD Elise Noel-Savina, MD Principal Investigator Sandrine Pontier-Marchandise, MD Sub-Investigator Alain Didier, MD Sub-Investigator
Location Countries

France

Verification Date

August 2018

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: High Flow Oxygen (HFO)

Type: Experimental

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.

Label: Non Invasive Ventilation (NIV)

Type: Active Comparator

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

Acronym RespiFLOW
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov