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Completed

NCT Number: NCT03632577

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

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.

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Key information

Conditions

Respiratory Disease Respiration Disorders Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Larrey

Toulouse, 31049, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Primary outcome: Tolerance of each dispositive

    Time frame: Hours 0

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

  2. Primary outcome: Tolerance of each dispositive

    Time frame: Hours 6

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

  3. Primary outcome: Tolerance of each dispositive

    Time frame: Hours 24

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

  4. Primary outcome: Tolerance of each dispositive

    Time frame: Hours 48

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

Secondary outcomes

  1. Dyspnea scale of Borg

    Time frame: Hours 6

    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).

  2. Dyspnea scale of Borg

    Time frame: Hours 24

    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).

  3. Dyspnea scale of Borg

    Time frame: 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).

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

    Time frame: Month 3

    defined by reintubation or exchange of treatment or premature discontinuation of treatment

  5. Hematosis : PaO2, PaCO2, pH

    Time frame: hours 6

    Measurement of PaO2, PaCO2 and pH

  6. Hematosis : PaO2, PaCO2, pH

    Time frame: hours 24

    Measurement of PaO2, PaCO2 and pH

  7. Hematosis : PaO2, PaCO2, pH

    Time frame: hours 48

    Measurement of PaO2, PaCO2 and pH

  8. Duration of hospitalization in intensive care units, reanimation, hospital after extubation.

    Time frame: Month 3

    Measurement of hospitalization in intensive care units in days

  9. Mortality in ICU (continuous monitoring unit)

    Time frame: Month 3

    Measurement of mortality

  10. Mortality in hospital

    Time frame: Month 3

    Measurement of mortality

  11. Mortality at M1 and M3

    Time frame: Month 1

    Measurement of mortality

  12. Mortality at M1 and M3

    Time frame: Month 3

    Measurement of mortality

  13. Use of another technic (HFO or NVI) in time

    Time frame: hours 72

    Duration of use of the device (VNI, OHD) at H72

  14. Respiratory congestion (number of fibroscopy for airway's desobstruction, number of respiratory kinesitherapy consults, radiological atelectasis)

    Time frame: month 3

    Measurement of respiratory congestion by : number of fibroscopy for airway's desobstruction, number of respiratory kinesitherapy consults and radiological atelectasis

  15. New intubation rate at H48

    Time frame: Hours 48

    New intubation rate at H48

  16. New intubation rate at H72

    Time frame: Hours 72

    New intubation rate at H72

  17. SpO2 stability

    Time frame: hours 48

    Percentage of time spent below 88% and above 92% of SpO2

  18. SpO2 stability

    Time frame: hours 72

    Percentage of time spent below 88% and above 92% of SpO2

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study 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

Acronym: RespiFLOW

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 15, 2018
Registry last updated
Nov 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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