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NCT Number: NCT06675045

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this 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. 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient, male or female, aged ≥ 18 years
  • Patient admitted to intensive care with acute hypoxaemic respiratory failure
  • Patient treated with high-flow oxygen therapy

Exclusion criteria

  • Patient admitted to intensive care with invasive ventilation
  • Patient with therapeutic abstention for intubation
  • Pregnant or breast-feeding women

Treatment and study plan

Respiratory variability monitoring

Other

Respiratory variability will be measured using a belt equipped with an external sensor allowing automatic and continuous analysis of thoracic movement by frequency analysis

Primary outcomes

  1. Coefficient of variation

    Time frame: Day 1 and Day 2

    Each respiratory cycle is defined by an inspiratory time followed by an expiratory time.

Study contacts

Contact information is provided by the study sponsor or research team.

Kais BEN HASSEN, MD

CONTACT

[email protected]

+33491171421

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Registry information

Official study title

Description of Respiratory Variability in Patients With Acute Hypoxemic Respiratory Failure and Placed on High Flow Oxygen Therapy - Exploratory Study

Acronym: HYPOXEVARIA

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 5, 2024
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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