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

NCT06675045 | Not Yet Recruiting

• 1 other identifier: 2024-A01080-47
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Acute Respiratory Insufficiency

Outcome Measures

Primary Outcomes (1)

• Coefficient of variation

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

  Day 1 and Day 2

Study Arms (1)

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

Other: Respiratory variability monitoring

Interventions

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

Respiratory Variability Monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead

Study Officials

• Kais BEN HASSEN, MD

  Hôpital privé de Clairval

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kais BEN HASSEN, MD

CONTACT

+33491171421; kais.benhassen@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: November 5, 2024
• Study Start: December 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share