Effects of High-flow Oxygen Therapy and Non-invasive Ventilation on Lung Volumes and on Upper Airway

NCT05643911 | Recruiting

• 1 other identifier: RECHMPL22_0510
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

Respiratory failure is the most frequent organ failure and cause for admission in the Intensive Care Unit (ICU) . It is a severe complication with an ICU mortality ranged from 31% to 33%. Symptomatic treatment of hypoxemic respiratory failure is a controversial topic with different options: 1) standard oxygen therapy, 2) high flow nasal cannula oxygen therapy (HFNC) and 3) non-invasive ventilation (NIV). The aim of the study is to compare HFNC versus NIV ventilation using CT scan. The hypothesis of this study is that in hypoxemic critically ill patients, the increase of lung volumes with NIV would be significantly higher than the increase of lung volumes with HFNC.

Conditions

Respiratory Failure

Keywords

intensive care; non-invasive ventilation; high-flow nasal oxygen therapy; hypoxemic respiratory failure; upper airway

Outcome Measures

Primary Outcomes (2)

• Variation in poorly aerated lung volume

  The poorly aerated volume will be measured by CT scan

  the day of inclusion

• Variation in non-aereted lung volume

  The non-aereted volume will be measured by CT scan

  the day of inclusion

Secondary Outcomes (9)

• Variation in cross-sectional upper airway area

  the day of inclusion

• Variation in normally aerated lung volume

  the day of inclusion

• Variation in Positive End Expiratory Pressure (PEEP)

  the day of inclusion

• Variation in Total lung volume

  the day of inclusion

• Variation in O2 gas exchange

  the day of inclusion

Study Arms (2)

HFNC (Hight-flow oxygen therapy)

EXPERIMENTAL

In the HFNC group, patients will receive HFNC oxygen therapy for 20 minutes. Oxygen will be passed through a heated humidifier and continuously delivered through medium or large nasal cannulas (OptiflowTM, Fisher and Paykel Healthcare) depending on patient anatomy, with a gas flow of 50 litres per minute and the FiO2 will be adjusted to maintain a SpO2 between 95% and 98%.

Procedure: HFNC

Non-invasive ventilation (NIV)

ACTIVE COMPARATOR

In the NIV Group, patients will receive NIV for 20 minutes delivered with a naso-buccal or face mask according to the patient's tolerance. The pressure-support level will be adjusted with the aim of an expired tidal volume of 6 to 8 ml per kilogram of predicted body weight, with a positive end-expiratory pressure (PEEP) of 5 cmH2O. The FiO2 will be adjusted to maintain a SpO2 between 95% and 98%.

Procedure: NIV

Interventions

HFNC PROCEDURE

In the HFNC group, patients will receive HFNC oxygen therapy for 20 minutes.

HFNC (Hight-flow oxygen therapy)

NIV PROCEDURE

Patients will receive NIV for 20 minutes delivered with a naso-buccal or face mask according to the patient's tolerance.

Non-invasive ventilation (NIV)

Eligibility Criteria

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

You may qualify if:

• Patient with hypoxemia at any time of ICU stay defined as follow: standard oxygen therapy flow ≥ 3L/min to maintain a pulsed oxygen saturation ≥ 95%
• Adult (age ≥ 18 years)
• (2) A CT scan prescribed by the physician in charge of the patient as part of the exploration of the patient's pathology and not as part of a "dedicated" prescription for the study.

You may not qualify if:

• NIV contraindication (need for immediate endotracheal intubation and mechanical ventilation; hemodynamic instability defined by systolic blood pressure \< 90 mmHg or mean blood pressure \< 65 mmHg, use of vasopressors; Glasgow Coma Scale score of 12 points or less)
• History of recent facial trauma not compatible with the use of nasal cannulas
• Pregnancy
• Refusal of study participation
• protected person
• Patient not affiliated to the social security system or not benefiting from such a system
• Lack of signed informed consent

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Centre Hospitalier Universitaire Montpellier, Saint Eloi

Montpellier, Languedoc-Roussillon, 34295, France

RECRUITING

Related Publications (1)

• Monet C, Piron L, Pressac M, Molinari N, De Jong A, Guiu B, Jaber S. Study protocol for the HONIVAH trial: a single-centre randomised study assessing high-flow oxygen therapy versus non-invasive ventilation on lung volumes and the upper airway in hypoxemic critically ill patients. BMJ Open. 2025 Sep 16;15(9):e106340. doi: 10.1136/bmjopen-2025-106340.

  PMID: 40962342 DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Central Study Contacts

Samir JABER

CONTACT

0033467337271; s-jaber@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2022
• First Posted: December 9, 2022
• Study Start: January 27, 2023
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: May 29, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 12 months after the main publication
• Access Criteria: Data are provided to qualified investigators free of charge. Required documents to request data include a summary of the research plan, request form, and institutional review board (IRB) review. Dataset will be shared after careful examination by the study board of investigators.

Locations

FR (1)