NCT07228676

INSPIRatory Efforts Estimation Under High-flow Nasal Oxygen

INSPIRatory Efforts Estimation Under High-flow Nasal Oxygen: a Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Poitiers University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

High-flow nasal oxygen (HFNO) is recommended as first-line treatment to prevent intubation in acute hypoxemic respiratory failure and to prevent reintubation after extubation. Accumulating data suggest that strong inspiratory efforts and their persistence are associated with HFNO failure. However, tools to monitor continuously and noninvasively inspiratory efforts are lacking. The investigators have developed an algorithm estimating noninvasively inspiratory efforts under HFNO. This pilot study aims at testing the feasibility of estimating inspiratory efforts in patients treated with HNFO.

Detailed description

High-flow nasal oxygen (HFNO) is recommended as first-line treatment to prevent intubation in acute hypoxemic respiratory failure and to prevent reintubation after extubation (alone in patients at low-risk of extubation failure, alternating with noninvasive ventilation in patients at high-risk of extubation failure). It consists in delivering high flow of heated and humidified gas enriched with oxygen through nasal cannulas. However, HFNO failure occurs in 30 to 50% of cases in acute hypoxemic respiratory failure and 10 to 20% of cases after extubation. Accumulating data suggest that strong inspiratory efforts and their persistence are associated with HFNO failure. However, the monitoring of inspiratory efforts is challenging, especially in patients breathing spontaneously through the nose under HFNO. On a bench study, the investigators have developed an algorithm estimating noninvasively inspiratory efforts under HFNO based on the analysis of tracings of pressure and flow delivered by the HFNO device using an extracorporeal sensor. The coefficient of determination of the algorithm was high (R2=0.92). This pilot study aims at testing the feasibility of estimating inspiratory efforts in patients treated with HNFO.

Conditions

• Oxygen
• Respiratory Insufficiency
• Work of Breathing
• Dyspnea

Interventions

Type	Name	Description
OTHER	Non-invasive estimation of inspiratory effort	As soon as possible after inclusion and 2 hours later, tracings of pressure and flow delivered by the HFNO device will be collected using a noninvasive extracorporeal sensor placed between the nasal cannulas and the HFNO device, as well as vital signs and dyspnea. At each visit, tracings will be collected for 10 minutes using the HFNO flow set by the clinician and for 10 minutes using an HFNO flow of 30 L/min allowing the patient breathing mouth closed. During the recordings, patients will be monitored closely at the bedside by the investigator. Estimated inspiratory efforts under HFNO will be calculated a posteriori. HFNO failure (intubation or reintubation) will be assessed at day 7 of inclusion. Vital status will be assessed at day 28 of inclusion.

Timeline

• Start date: 2025-11-29
• Primary completion: 2026-03-13
• Completion: 2026-04-09
• First posted: 2025-11-14
• Last updated: 2026-04-14

Locations

1 site across 1 country: France