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

Toulouse University Hospital

Status: Completed

Conditions: Respiratory Disease

Treatments: Device: High Flow Oxygen (HFO); Device: Non Invasive Ventilation (NIV)

Study type: Interventional

Funder types: Other

Identifiers

NCT03632577

RC31/16/8769

Details and patient eligibility

About

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.

Full 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.

Enrollment: 55 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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55 participants in 2 patient groups

High Flow Oxygen (HFO)

Experimental group

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.

Treatment:

Device: High Flow Oxygen (HFO)

Non Invasive Ventilation (NIV)

Active Comparator group

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

Treatment:

Device: Non Invasive Ventilation (NIV)