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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hypoxemic Respiratory Failure

Intervention / Treatment
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* Device: Cyclometer Ergometer


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Optiflow nasal googles<br>Oxygen provided by means of high throughput nasal googles (Optiflow, Fisher&Paykel- New Zealand). | Device: Cyclometer Ergometer<br>* 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.<br>|
| Active Comparator: Venturi mask<br>Oxygen provided by means of a Venturi mask. | Device: Cyclometer Ergometer<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulsated oxygen saturation (Sp02) | SpO2 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). | Baseline | 
| Pulsated oxygen saturation (Sp02) | SpO2 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). | 12 minutes (maximal effort) | 
| Oxygen inspired fraction (FiO2) | Oxygen inspired fraction (FiO2) is the fraction or percentage of oxygen present in the gas mixture that a person breathes. | Baseline | 
| Oxygen inspired fraction (FiO2) | Oxygen inspired fraction (FiO2) is the fraction or percentage of oxygen present in the gas mixture that a person breathes. | 12 minutes (maximal effort) | 
| Blood gasometry | Arterial blood analysis | Baseline | 
| Blood gasometry | Arterial blood analysis | 12 minutes (maximal effort) | 
| Heart rate | The heart rate is the number of heartbeats per unit minute. | Baseline | 
| Heart rate | The heart rate is the number of heartbeats per minute. | 12 minutes (maximal effort) | 
| Respiratory rate | Number of breath cycles (inspiration and expiration) per minute. | Baseline | 
| Respiratory rate | Number of breath cycles (inspiration and expiration) per minute. | 12 minutes (maximal effort) | 
| Mean arterial pressure | Mean arterial pressure | Baseline | 
| Mean arterial pressure | Mean arterial pressure | 12 minutes (maximal effort) | 
| Systolic blood pressure | Systolic blood pressure (pressure in the artery as the heart contracts) | Baseline | 
| Systolic blood pressure | Systolic blood pressure (pressure in the artery as the heart contracts) | 12 minutes (maximal effort) | 
| Borg score | 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). | 12 minutes (maximal effort) | 
| Forced expiratory volume per second (FEV1) | The 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. | Baseline | 
| Functional residual capacity (CFR) | Volume of air remaining in the airways after a spontaneous expiration (not forced) | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Age | Age | Baseline | 
| Weight | Weight | Baseline | 
| Sex | Sex | Baseline |