NCT06675045: HYPOXEVARIA

Respiratory Variability in Patients With Acute Hypoxemic Respiratory Failure and Placed on High Flow Oxygen Therapy

Not yet recruiting NA Last updated 19 November 2025

What this trial tests

NA trial testing Respiratory variability monitoring in Acute Respiratory Insufficiency in 60 participants. Not yet recruiting.

Timeline

1 December 2025

Primary endpoint
30 June 2026

30 June 2026

Quick facts

Lead sponsor	GCS Ramsay Santé pour l'Enseignement et la Recherche
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	60
Start date	1 December 2025
Primary completion	30 June 2026
Estimated completion	30 June 2026

Drugs / interventions tested

• Respiratory variability monitoring

Conditions studied

• Acute Respiratory Insufficiency — all drugs for Acute Respiratory Insufficiency →

Sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche — full company profile →

Who can join

18 and older, any sex, with Acute Respiratory Insufficiency. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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.

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.