Clinical trial NCT05643911: Effects of High-flow Oxygen Therapy and Non-invasive Ventilation on Lung Volumes and on Upper Airway
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Respiratory Failure
Keywords: intensive care
non-invasive ventilation
high-flow nasal oxygen therapy
hypoxemic respiratory failure
upper airway
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2022-12-09
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Variation in poorly aerated lung volume
timeFrame: the day of inclusion
measure: Variation in non-aereted lung volume
timeFrame: the day of inclusion
Secondary outcomes:
measure: Variation in cross-sectional upper airway area
timeFrame: the day of inclusion
measure: Variation in normally aerated lung volume
timeFrame: the day of inclusion
measure: Variation in Positive End Expiratory Pressure (PEEP)
timeFrame: the day of inclusion
measure: Variation in Total lung volume
timeFrame: the day of inclusion
measure: Variation in O2 gas exchange
timeFrame: the day of inclusion
measure: Variation in CO2 gas exchange
timeFrame: the day of inclusion
measure: Variation in respiratory rate
timeFrame: the day of inclusion
measure: Variation in cardiac output (Qc)
timeFrame: the day of inclusion
measure: Variation in patient comfort
timeFrame: the day of inclusion
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Centre Hospitalier Universitaire Montpellier, Saint Eloi
state: Languedoc-Roussillon
Study officials:
References: