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

Effects of High-flow Oxygen Therapy and Non-invasive Ventilation on Lung Volumes and on Upper Airway in Hypoxemic Critical Care Patients: a Physiological Randomized Controlled Trial

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05643911
Acronym
HONIVAH
Enrollment
56
Registered
2022-12-09
Start date
2023-01-27
Completion date
2025-01-31
Last updated
2024-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Failure

Keywords

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

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.

Interventions

PROCEDUREHFNC

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

PROCEDURENIV

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

Sponsors

University Hospital, Montpellier
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Variation in poorly aerated lung volumethe day of inclusionThe poorly aerated volume will be measured by CT scan
Variation in non-aereted lung volumethe day of inclusionThe non-aereted volume will be measured by CT scan

Secondary

MeasureTime frameDescription
Variation in normally aerated lung volumethe day of inclusionThe normally aerated lung volume will be measured by CT scan
Variation in Positive End Expiratory Pressure (PEEP)the day of inclusion
Variation in Total lung volumethe day of inclusionThe total lung volume will be measured by CT-scan
Variation in CO2 gas exchangethe day of inclusionChange in PaO2 in mmHg
Variation in respiratory ratethe day of inclusionRespiratory rate is the number of cycles per minute
Variation in cardiac output (Qc)the day of inclusionthe cardiac output is in L/min
Variation in patient comfortthe day of inclusionPatient comfort through a numeric rating scale (NRS) from 0 (no discomfort) to 10 (maximum imaginable discomfort)
Variation in O2 gas exchangethe day of inclusionChange in PaO2 in mmHg
Variation in cross-sectional upper airway areathe day of inclusionThe variation will be measured by CT-scan in mm

Countries

France

Contacts

Primary ContactSamir JABER
s-jaber@chu-montpellier.fr0033467337271

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026