NCT03632577: RespiFLOW

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

Completed NA Last updated 10 November 2020

What this trial tests

NA trial testing High Flow Oxygen (HFO) in Respiratory Disease in 55 participants. Completed in 15 October 2019.

Timeline

19 December 2017

Primary endpoint
26 June 2019

15 October 2019

Quick facts

Lead sponsor	University Hospital, Toulouse
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	55
Start date	19 December 2017
Primary completion	26 June 2019
Estimated completion	15 October 2019
Sites	1 location across France

Drugs / interventions tested

• High Flow Oxygen (HFO)
• Non Invasive Ventilation (NIV)

Conditions studied

• Respiratory Disease — all drugs for Respiratory Disease →

Sponsor

University Hospital, Toulouse

Who can join

18 and older, any sex, with Respiratory Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. High-flow nasal cannulae for respiratory support in adult intensive care patients.
   Corley A, Rickard CM, Aitken LM, Johnston A, et al · · 2017 · cited 44× · PMID 28555461 · DOI 10.1002/14651858.cd010172.pub2
2. High-flow nasal cannulae for respiratory support in adult intensive care patients.
   Lewis SR, Baker PE, Parker R, Smith AF. · · 2021 · cited 43× · PMID 33661521 · DOI 10.1002/14651858.cd010172.pub3