OxygenINSPIRE-PilotNCT07228676
INSPIRatory Efforts Estimation Under High-flow Nasal Oxygen
A study testing Non-invasive estimation of inspiratory effort in people with Oxygen and Respiratory Insufficiency, run by Poitiers University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oxygen, Respiratory Insufficiency, Work of Breathing
- What is being tested?
- Non-invasive estimation of inspiratory effort
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 29 Nov 2025to 9 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Do-not-intubate order at inclusion
- Already included in the study
- Under legal protection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: INSPIRatory Efforts Estimation Under High-flow Nasal Oxygen: a Pilot Study
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.
Read the 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
- Being tested
- Non-invasive estimation of inspiratory effort
- Keywords
- high-flow nasal oxygen, respiratory failure, inspiratory efforts, dyspnea
- Medical subject headings
- Respiratory Insufficiency, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive estimation of inspiratory effortOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Critically ill patients treated with HFNO | Experimental | Patients treated with HFNO for less than 24 hours in ICU Receives: Other: Non-invasive estimation of inspiratory effort |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Inspiratory efforts estimated under HFNO in patients breathing through the nose at a flow rate of 30 L/min 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.
HFNO failure is defined as intubation or reintubation or death at day 7 after inclusion.
Measured: 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)
Inspiratory efforts estimated under HFNO in patients breathing through the nose at a flow rate of 30 L/min 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.
Measured: 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)
The change in inspiratory efforts is defined as the decrease in estimated inspiratory efforts under HFNO in patients breathing through the nose at a flow rate of 30 L/min calculated a posteriori using the algorithm developed on the bench based on the pressure and flow signals delivered by the HFNO device between the first and second recording.
HFNO failure is defined as intubation or reintubation or death at day 7 after inclusion.
Measured: 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)
The change in inspiratory efforts is defined as the decrease in estimated inspiratory efforts under HFNO in patients breathing through the nose at a flow rate of 30 L/min calculated a posteriori using the algorithm developed on the bench based on the pressure and flow signals delivered by the HFNO device between the first and second recording.
Measured: Day 28
Inspiratory efforts estimated under HFNO according to dyspnea at each visit
Inspiratory effort estimated under HFNO in patients breathing through the nose at a flow rate of 30 L/min at each recording, and dyspnea score.
Dyspnea is defined as a value ≥ 4/10 on a numerical rating scale.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2025
- Study start29 Nov 2025
- Primary completion13 Mar 2026
- Study completion9 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OxygenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Céline ABONNEAU, Study chair, Poitiers University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07228676
- Sponsor's protocol ID
- 2025-A01663-46
- Acronym
- INSPIRE-Pilot
- Status last verified
- May 2026
- First submitted
- 17 Sep 2025
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This pilot study will be followed by a larger prospective observational study.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INSPIRatory Efforts Estimation Under High-flow Nasal Oxygen: a Pilot Study
- ClinicalTrials.gov ID
- NCT07228676
- Acronym / sponsor ID
- INSPIRE-Pilot / 2025-A01663-46
- Conditions
- Oxygen, Respiratory Insufficiency, Work of Breathing, Dyspnea
- Keywords
- high-flow nasal oxygen, respiratory failure, inspiratory efforts, dyspnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 29 Nov 2025 (actual)
- Primary completion
- 13 Mar 2026 (actual)
- Study completion
- 9 Apr 2026 (actual)
- First posted
- 14 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Critically ill patients treated with HFNO | Experimental | Other: Non-invasive estimation of inspiratory effortPatients treated with HFNO for less than 24 hours in ICU |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Do-not-intubate order at inclusion
- Already included in the study
- Under legal protection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-invasive estimation of inspiratory effortAs 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. | Other | Critically ill patients treated with HFNO |
Primary outcome
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.
Time frame: Day 1
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.
5 secondary outcomes
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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Day 28
Inspiratory efforts estimated under HFNO according to dyspnea at each visit
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No. This pilot study will be followed by a larger prospective observational study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Céline ABONNEAU study chair
Poitiers University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive estimation of inspiratory effort in people with Oxygen and Respiratory Insufficiency, run by Poitiers University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.