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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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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

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.

Kais BEN HASSEN, MD contact

+33491171421

kais.benhassen@gmail.com

France1 site, 1 recruiting
  • Hôpital Privé Clairval

    Marseille, 13009

    KAIS BEN HASSEN, MD, + 33 6 38 12 22 86, kais.benhassen@gmail.com

    Recruiting

Other trials in France

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.

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 groups in NCT06675045
Study groupRoleWhat they receive
Respiratory Variability MonitoringExperimentalRespiratory 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.

  1. 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.

  1. First posted5 Nov 2024
  2. Study start2 Feb 2026
  3. Primary completion31 Oct 2027 (estimated)
  4. Study completion31 Oct 2027 (estimated)

Resources

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)
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

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