Acute Respiratory InsufficiencyHYPOXEVARIANCT06675045
Respiratory Variability in Patients With Acute Hypoxemic Respiratory Failure and Placed on High Flow Oxygen Therapy
A study testing Respiratory variability monitoring in people with Acute Respiratory Insufficiency, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
Recommendations from the European Respiratory Society are to use high-flow oxygen therapy rather than conventional oxygen therapy and non-invasive ventilation (NIV) in cases of acute hypoxaemic respiratory failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Insufficiency
- What is being tested?
- Respiratory variability monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 2 Feb 2026to 31 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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, male or female, aged ≥ 18 years
- Patient admitted to intensive care with acute hypoxaemic respiratory failure
- Patient treated with high-flow oxygen therapy
Who cannot join
- Patient admitted to intensive care with invasive ventilation
- Patient with therapeutic abstention for intubation
- Pregnant or breast-feeding women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Privé Clairval
Marseille, 13009
KAIS BEN HASSEN, MD, + 33 6 38 12 22 86, kais.benhassen@gmail.com
About this study
Official title: Description of Respiratory Variability in Patients With Acute Hypoxemic Respiratory Failure and Placed on High Flow Oxygen Therapy - Exploratory Study
Recommendations from the European Respiratory Society are to use high-flow oxygen therapy rather than conventional oxygen therapy and non-invasive ventilation (NIV) in cases of acute hypoxaemic respiratory failure.
Studies have shown that high-flow oxygen therapy can reduce the need for intubation and the initiation of NIV without reducing mortality. In addition, by improving oxygenation, high-flow oxygen therapy can create a feeling of security which may delay endotracheal intubation.
Read more
Two studies have suggested that mortality is higher in patients receiving delayed intubation (≥ 48 hours) after failure of high flow oxygen therapy. Another study suggests that delayed endotracheal intubation after high-flow oxygen therapy ≥ 48 hours increases the risk of patient mortality independently of comorbidities and severity of illness on admission. Finally, other results suggest that the increased risk of mortality may be significant after 36 hours of high-flow oxygen therapy. It is therefore difficult to determine the right time for intubation and invasive ventilation.
A diagnostic decision aid could be of great use to the attending physician in optimising the patient's respiratory assistance strategy, whether invasive or non-invasive. Consequently, any clinical marker that can provide early detection of altered respiratory status on high-flow oxygen therapy deserves to be evaluated.
Respiratory variability is synonymous with respiratory 'good health'. A decrease in this same variabilitý is pathological and indicates an increase in the level of loads imposed on the respiratory system. It means that the measurement of respiratory variability indices may be one of these markers
There are devices for non-invasive, continuous monitoring of respiratory variability, with automated frequency analysis of thoracic movement. In this study, respiratory variability indices will be measured in patients admitted to intensive care under high-flow oxygen therapy using an external sensor called REVAMODE.
Read the detailed description
Recommendations from the European Respiratory Society are to use high-flow oxygen therapy rather than conventional oxygen therapy and non-invasive ventilation (NIV) in cases of acute hypoxaemic respiratory failure.
Studies have shown that high-flow oxygen therapy can reduce the need for intubation and the initiation of NIV without reducing mortality. In addition, by improving oxygenation, high-flow oxygen therapy can create a feeling of security which may delay endotracheal intubation. Delaying intubation would expose the patient to respiratory effort, leading to self-inflicted lung injury by a mechanism similar to ventilation-induced lung injury. Self-inflicted lung injury may increase mortality in acute respiratory distress syndrome (ARDS).
Two studies have suggested that mortality is higher in patients receiving delayed intubation (≥ 48 hours) after failure of high flow oxygen therapy. Another study suggests that delayed endotracheal intubation after high-flow oxygen therapy ≥ 48 hours increases the risk of patient mortality independently of comorbidities and severity of illness on admission. Finally, other results suggest that the increased risk of mortality may be significant after 36 hours of high-flow oxygen therapy. It is therefore difficult to determine the right time for intubation and invasive ventilation.
A diagnostic decision aid could be of great use to the attending physician in optimising the patient's respiratory assistance strategy, whether invasive or non-invasive. Consequently, any clinical marker that can provide early detection of altered respiratory status on high-flow oxygen therapy deserves to be evaluated.
Respiratory variability is synonymous with respiratory 'good health'. A decrease in this same variabilitý is pathological and indicates an increase in the level of loads imposed on the respiratory system. For this reason, this study is based on the hypothesis that the measurement of respiratory variability indices may be one of these markers.
There are devices for non-invasive, continuous monitoring of respiratory variability, with automated frequency analysis of thoracic movement. In this study, respiratory variability indices will be measured in patients admitted to intensive care under high-flow oxygen therapy using an external sensor called REVAMODE.
- Conditions
- Acute Respiratory Insufficiency
- Being tested
- Respiratory variability monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory variability monitoringOther
Respiratory variability will be measured using a belt equipped with an external sensor allowing automatic and continuous analysis of thoracic movement by frequency analysis
| Study group | Role | What they receive |
|---|---|---|
| Respiratory Variability Monitoring | Experimental | Respiratory variability will be measured using a belt equipped with an external sensor allowing automatic and continuous analysis of thoracic movement by frequency analysis Receives: Other: Respiratory variability monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coefficient of variation
Each respiratory cycle is defined by an inspiratory time followed by an expiratory time.
Measured: Day 1 and Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start2 Feb 2026
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory InsufficiencyStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kais BEN HASSEN, MD, Principal investigator, Hôpital privé de Clairval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06675045
- Sponsor's protocol ID
- 2024-A01080-47
- Acronym
- HYPOXEVARIA
- Status last verified
- Aug 2026
- First submitted
- 4 Nov 2024
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Description of Respiratory Variability in Patients With Acute Hypoxemic Respiratory Failure and Placed on High Flow Oxygen Therapy - Exploratory Study
- ClinicalTrials.gov ID
- NCT06675045
- Acronym / sponsor ID
- HYPOXEVARIA / 2024-A01080-47
- Conditions
- Acute Respiratory Insufficiency
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 2 Feb 2026 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 5 Nov 2024 (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.
Recommendations from the European Respiratory Society are to use high-flow oxygen therapy rather than conventional oxygen therapy and non-invasive ventilation (NIV) in cases of acute hypoxaemic respiratory failure.
Studies have shown that high-flow oxygen therapy can reduce the need for intubation and the initiation of NIV without reducing mortality. In addition, by improving oxygenation, high-flow oxygen therapy can create a feeling of security which may delay endotracheal intubation.
Two studies have suggested that mortality is higher in patients receiving delayed intubation (≥ 48 hours) after failure of high flow oxygen therapy. Another study suggests that delayed endotracheal intubation after high-flow oxygen therapy ≥ 48 hours increases the risk of patient mortality independently of comorbidities and severity of illness on admission. Finally, other results suggest that the increased risk of mortality may be significant after 36 hours of high-flow oxygen therapy. It is therefore difficult to determine the right time for intubation and invasive ventilation.
A diagnostic decision aid could be of great use to the attending physician in optimising the patient's respiratory assistance strategy, whether invasive or non-invasive. Consequently, any clinical marker that can provide early detection of altered respiratory status on high-flow oxygen therapy deserves to be evaluated.
Respiratory variability is synonymous with respiratory 'good health'. A decrease in this same variabilitý is pathological and indicates an increase in the level of loads imposed on the respiratory system. It means that the measurement of respiratory variability indices may be one of these markers
There are devices for non-invasive, continuous monitoring of respiratory variability, with automated frequency analysis of thoracic movement. In this study, respiratory variability indices will be measured in patients admitted to intensive care under high-flow oxygen therapy using an external sensor called REVAMODE.
Detailed description
Recommendations from the European Respiratory Society are to use high-flow oxygen therapy rather than conventional oxygen therapy and non-invasive ventilation (NIV) in cases of acute hypoxaemic respiratory failure.
Studies have shown that high-flow oxygen therapy can reduce the need for intubation and the initiation of NIV without reducing mortality. In addition, by improving oxygenation, high-flow oxygen therapy can create a feeling of security which may delay endotracheal intubation. Delaying intubation would expose the patient to respiratory effort, leading to self-inflicted lung injury by a mechanism similar to ventilation-induced lung injury. Self-inflicted lung injury may increase mortality in acute respiratory distress syndrome (ARDS).
Two studies have suggested that mortality is higher in patients receiving delayed intubation (≥ 48 hours) after failure of high flow oxygen therapy. Another study suggests that delayed endotracheal intubation after high-flow oxygen therapy ≥ 48 hours increases the risk of patient mortality independently of comorbidities and severity of illness on admission. Finally, other results suggest that the increased risk of mortality may be significant after 36 hours of high-flow oxygen therapy. It is therefore difficult to determine the right time for intubation and invasive ventilation.
A diagnostic decision aid could be of great use to the attending physician in optimising the patient's respiratory assistance strategy, whether invasive or non-invasive. Consequently, any clinical marker that can provide early detection of altered respiratory status on high-flow oxygen therapy deserves to be evaluated.
Respiratory variability is synonymous with respiratory 'good health'. A decrease in this same variabilitý is pathological and indicates an increase in the level of loads imposed on the respiratory system. For this reason, this study is based on the hypothesis that the measurement of respiratory variability indices may be one of these markers.
There are devices for non-invasive, continuous monitoring of respiratory variability, with automated frequency analysis of thoracic movement. In this study, respiratory variability indices will be measured in patients admitted to intensive care under high-flow oxygen therapy using an external sensor called REVAMODE.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Respiratory Variability Monitoring | Experimental | Other: Respiratory variability monitoringRespiratory variability will be measured using a belt equipped with an external sensor allowing automatic and continuous analysis of thoracic movement by frequency analysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient, male or female, aged ≥ 18 years
- Patient admitted to intensive care with acute hypoxaemic respiratory failure
- Patient treated with high-flow oxygen therapy
Key exclusion criteria (3 listed)
- Patient admitted to intensive care with invasive ventilation
- Patient with therapeutic abstention for intubation
- Pregnant or breast-feeding women
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 |
|---|---|---|
| Respiratory variability monitoringRespiratory variability will be measured using a belt equipped with an external sensor allowing automatic and continuous analysis of thoracic movement by frequency analysis | Other | Respiratory Variability Monitoring |
Primary outcome
Coefficient of variation
Time frame: Day 1 and Day 2
Each respiratory cycle is defined by an inspiratory time followed by an expiratory time.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No
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Influence of Patient Positioning During Nasal Lavage
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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.
Kais BEN HASSEN, MD principal investigator
Hôpital privé de Clairval
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Respiratory variability monitoring in people with Acute Respiratory Insufficiency, run by GCS Ramsay Santé pour l'Enseignement et la Recherche 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 3 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: looking for participants now, as of the sponsor's last update on 20 Aug 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kais BEN HASSEN, MD (+33491171421, kais.benhassen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coefficient of variation (time frame: Day 1 and Day 2). 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 20 Aug 2026.