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

NCT ID: NCT05643911

Last Updated: 2024-05-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-27
• Study Completion Date: 2025-01-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

HFNC (Hight-flow oxygen therapy)

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%.

Group Type: EXPERIMENTAL

HFNC

Intervention Type: PROCEDURE

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

Non-invasive ventilation (NIV)

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%.

Group Type: ACTIVE_COMPARATOR

NIV

Intervention Type: PROCEDURE

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

Interventions

HFNC

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

Intervention Type: PROCEDURE

NIV

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre Hospitalier Universitaire Montpellier, Saint Eloi

Montpellier, Languedoc-Roussillon, France

Site Status: RECRUITING

Countries

France

Central Contacts

Samir JABER

Role: CONTACT

s-jaber@chu-montpellier.fr

0033467337271

Facility Contacts

Samir JABER, MD, PhD

Role: primary

s-jaber@chu-montpellier.fr

+33467337271

References

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.

Reference Type: DERIVED

PMID: 40962342 (View on PubMed)

Other Identifiers

RECHMPL22_0510

Identifier Type: -

Identifier Source: org_study_id