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

Not Applicable

Completed

• Conditions: Hypoxemic Respiratory Failure
• Interventions: Device: Cyclometer Ergometer

• Registration Number: NCT04022603
• Lead Sponsor: Dr David DE BELS

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-18
• Study First Submitted: 2019-07-15
• Study First Submitted QC: 2019-07-16
• Study First Posted: 2019-07-17
• Primary Completion: 2020-08-03
• Study Completion: 2020-08-03
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-03
• Last Update Posted: 2022-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Optiflow nasal googles	Cyclometer Ergometer	Oxygen provided by means of high throughput nasal googles (Optiflow, Fisher\&Paykel- New Zealand).
Venturi mask	Cyclometer Ergometer	Oxygen provided by means of a Venturi mask.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Age	Baseline	Age
Weight	Baseline	Weight
Sex	Baseline	Sex

Trial Locations

Locations (1)

CHU Brugmann; 🇧🇪 Brussels, Belgium