Clinical trial NCT04022603: Impact of High-level Oxygen Therapy on the Reconditioning of Type I Hypoxemic Respiratory Insufficiency Patients in Intensive Care
Official title: Impact of High-level Oxygen Therapy on the Reconditioning of Type I Hypoxemic Respiratory Insufficiency Patients in Intensive Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoxemic Respiratory Failure
Lead sponsor: Brugmann University Hospital
Sponsor class: OTHER
First posted: 2019-07-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: High-throughput oxygen therapy is known as an alternative to non-invasive ventilation, with a benefit in terms of survival in non-hypercapnic respiratory failure patients.

The use of high-throughput oxygen therapy is well studied in stable chronic obstructive pulmonary disease (COPD) patients and has as known effects the decrease of transcutaneous CO2 and respiratory rate, and the increase in the inspiratory/expiratory time report, in the tidal volume and in the forced expiratory volume per second.

In the event of an exacerbation, high-flow oxygen therapy has shown to be beneficial in terms of increased mean airway pressure, tidal volume with a decrease in hypercapnia, and respiratory rate.

The net effect on the CO2 pressure is linked to the CO2 clearance of the dead anatomical space by the high throughput. The effect can be compared with the one of non invasive ventilation in a stable COPD patient.

Oxygen therapy, even in patients with non-hypoxic COPD at rest, has benefits in terms of performance and improvement of quality of life. High-throughput oxygen therapy has also shown a benefit in COPD patients in revalidation units, in terms of exercise performance and oxygenation.

However, the reconditioning of critical patients in acute situations, by means of nasal goggles, has never been studied.


Eligibility criteria: Inclusion Criteria:

* Acute respiratory insufficiency type I, oxygen partial pressure (PaO2) \<60 mmHg under oxygen without hypercapnia.
* Invasive arterial pressure measure

Exclusion Criteria:

* Hemodynamic instability
* Patient under continuous high throughput oxygen therapy
* Left cardiac insufficiency
* Arteritis of the lower limbs
* Neuromuscular pathology
* Osteo-articular limitations
* Hemoglobin inferior to 8g/dl

Primary outcomes:
measure: Pulsated oxygen saturation (Sp02)
timeFrame: Baseline
measure: Pulsated oxygen saturation (Sp02)
timeFrame: 12 minutes (maximal effort)
measure: Oxygen inspired fraction (FiO2)
timeFrame: Baseline
measure: Oxygen inspired fraction (FiO2)
timeFrame: 12 minutes (maximal effort)
measure: Blood gasometry
timeFrame: Baseline
measure: Blood gasometry
timeFrame: 12 minutes (maximal effort)
measure: Heart rate
timeFrame: Baseline
measure: Heart rate
timeFrame: 12 minutes (maximal effort)
measure: Respiratory rate
timeFrame: Baseline
measure: Respiratory rate
timeFrame: 12 minutes (maximal effort)
measure: Mean arterial pressure
timeFrame: Baseline
measure: Mean arterial pressure
timeFrame: 12 minutes (maximal effort)
measure: Systolic blood pressure
timeFrame: Baseline
measure: Systolic blood pressure
timeFrame: 12 minutes (maximal effort)
measure: Borg score
timeFrame: 12 minutes (maximal effort)
measure: Forced expiratory volume per second (FEV1)
timeFrame: Baseline
measure: Functional residual capacity (CFR)
timeFrame: Baseline
Secondary outcomes:
measure: Age
timeFrame: Baseline
measure: Weight
timeFrame: Baseline
measure: Sex
timeFrame: Baseline
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHU Brugmann
Study officials:
affiliation: CHU Brugmann
name: Sébastien Redant
role: PRINCIPAL_INVESTIGATOR
References: