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Impact of High-level Oxygen Therapy on the Reconditioning of Type I Hypoxemic Respiratory Insufficiency Patients in Intensive Care

Impact of High-level Oxygen Therapy on the Reconditioning of Type I Hypoxemic Respiratory Insufficiency Patients in Intensive Care

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04022603
Enrollment
30
Registered
2019-07-17
Start date
2017-08-18
Completion date
2020-08-03
Last updated
2022-03-04

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

Conditions

Hypoxemic Respiratory Failure

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.

Interventions

DEVICECyclometer Ergometer

The measurements are carried out on a max effort of 12 minutes on a cyclometer ergometer with a constant load (Motomed viva2 light). A first effort is made with a Venturi type mask whose Inspired Fraction in Oxygen (FiO2) is set for a pulsated oxygen saturation (SpO2) greater than or equal to 85%, and then a second at 2h interval with high-throughput googles (Optiflow) with the corresponding FiO2.

Sponsors

Dr David DE BELS
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

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

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

Design outcomes

Primary

MeasureTime frameDescription
Functional residual capacity (CFR)BaselineVolume of air remaining in the airways after a spontaneous expiration (not forced)
Systolic blood pressureBaselineSystolic blood pressure (pressure in the artery as the heart contracts)
Borg score12 minutes (maximal effort)The Borg scale is a quantitative measure of the perception of effort during exercise. The scale between 0 and 10 was designed to approximate the heart rate of a healthy young adult (effort 8 represents 80% of the cardiac frequency).
Forced expiratory volume per second (FEV1)BaselineThe Forced Expiratory Volume Per Second (FEV1) is the volume of air exhaled during the first second of a so-called forced exhalation, following deep inspiration. It is measured by spirometry.
Pulsated oxygen saturation (Sp02)BaselineSpO2 is an estimate of the amount of oxygen in the blood. More precisely, it represents the percentage of oxygenated hemoglobin (containing oxygen) relative to the total amount of hemoglobin in the blood (oxygenated hemoglobin and non-oxygenated hemoglobin).
Oxygen inspired fraction (FiO2)BaselineOxygen inspired fraction (FiO2) is the fraction or percentage of oxygen present in the gas mixture that a person breathes.
Blood gasometryBaselineArterial blood analysis
Heart rateBaselineThe heart rate is the number of heartbeats per unit minute.
Respiratory rateBaselineNumber of breath cycles (inspiration and expiration) per minute.
Mean arterial pressureBaselineMean arterial pressure

Secondary

MeasureTime frameDescription
WeightBaselineWeight
SexBaselineSex
AgeBaselineAge

Countries

Belgium

Outcome results

None listed

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