INSPIRatory Efforts Estimation Under High-flow Nasal Oxygen

NCT07228676 | Completed

• 1 other identifier: 2025-A01663-46
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Oxygen; Respiratory Insufficiency; Work of Breathing; Dyspnea

Keywords

high-flow nasal oxygen; respiratory failure; inspiratory efforts; dyspnea

Outcome Measures

Primary Outcomes (1)

• The detection of estimated inspiratory efforts under HFNO in patients breathing through the nose at a flow rate of 30 L/min in at least 16 of the 20 (≥ 80%) patients included.

  Inspiratory efforts will be calculated a posteriori using the algorithm developed on the bench, based on the pressure and flow signals delivered by the HFNO device collected during the first recording.

  Day 1

Secondary Outcomes (5)

• Inspiratory efforts estimated under HFNO in patients breathing through the nose at a flow rate of 30 L/min between HFNO success and failure in the overall population and in each subgroup (prevention of intubation and of reintubation)

  Day 7

• Inspiratory efforts estimated under HFNO in patients breathing through the nose at a flow rate of 30 L/min between survivors and non survivors at day 28 in the overall population and in each subgroup (prevention of intubation and of reintubation)

  Day 28

• The change in inspiratory efforts between the 2 visits between HFNO success and failure in the overall population and in each subgroup (prevention of intubation and of reintubation)

  Day 7

• The change in inspiratory efforts between the 2 visits between survivors and non survivors at day 28 in the overall population and in each subgroup (prevention of intubation and of reintubation)

  Day 28

• Inspiratory efforts estimated under HFNO according to dyspnea at each visit

  Day 1

Study Arms (1)

Critically ill patients treated with HFNO

EXPERIMENTAL

Patients treated with HFNO for less than 24 hours in ICU

Other: Non-invasive estimation of inspiratory effort

Interventions

Non-invasive estimation of inspiratory effort OTHER

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.

Critically ill patients treated with HFNO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient ≥ 18 yo admitted to the intensive care unit
• Treated with HFNO for less than 24h to prevent intubation of reintubation
• Affiliated to social insurance
• Consent to participate in the study

You may not qualify if:

• Already included in the study
• Under legal protection

Sponsors & Collaborators

• Poitiers University Hospital: lead

Study Sites (1)

Poitiers University Hospital

Poitiers, France

Location

MeSH Terms

Conditions

Respiratory Insufficiency; Dyspnea

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Céline ABONNEAU

  Poitiers University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: November 14, 2025
• Study Start: November 29, 2025
• Primary Completion: March 13, 2026
• Study Completion: April 9, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)