INSPIRatory Efforts Estimation Under High-flow Nasal Oxygen (INSPIRE-Pilot)

Poitiers University Hospital

Status: Enrolling

Conditions: Work of Breathing; Dyspnea; Respiratory Insufficiency; Oxygen

Treatments: Other: Non-invasive estimation of inspiratory effort

Study type: Interventional

Funder types: Other

Identifiers

NCT07228676

2025-A01663-46

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Do-not-intubate order at inclusion
• Already included in the study
• Under legal protection

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Critically ill patients treated with HFNO

Experimental group

Description:

Patients treated with HFNO for less than 24 hours in ICU

Treatment:

Other: Non-invasive estimation of inspiratory effort