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

Hypoxemic Respiratory Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04022603
• Other study ID #: CHUB-BPCO
• Status: Completed
• Phase: N/A
• Start date: August 18, 2017
• Est. completion date: August 3, 2020

Study information

• Verified date: March 2022
• Source: Brugmann University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 3, 2020
• Est. primary completion date: August 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypoxemic Respiratory Failure
• Pulmonary Valve Insufficiency
• Respiratory Insufficiency

Intervention

Device:
• Cyclometer 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.

Locations

Country	Name	City	State
Belgium	CHU Brugmann	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Dr David DE BELS

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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)
Primary	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
Primary	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)
Primary	Blood gasometry	Arterial blood analysis	Baseline
Primary	Blood gasometry	Arterial blood analysis	12 minutes (maximal effort)
Primary	Heart rate	The heart rate is the number of heartbeats per unit minute.	Baseline
Primary	Heart rate	The heart rate is the number of heartbeats per minute.	12 minutes (maximal effort)
Primary	Respiratory rate	Number of breath cycles (inspiration and expiration) per minute.	Baseline
Primary	Respiratory rate	Number of breath cycles (inspiration and expiration) per minute.	12 minutes (maximal effort)
Primary	Mean arterial pressure	Mean arterial pressure	Baseline
Primary	Mean arterial pressure	Mean arterial pressure	12 minutes (maximal effort)
Primary	Systolic blood pressure	Systolic blood pressure (pressure in the artery as the heart contracts)	Baseline
Primary	Systolic blood pressure	Systolic blood pressure (pressure in the artery as the heart contracts)	12 minutes (maximal effort)
Primary	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)
Primary	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
Primary	Functional residual capacity (CFR)	Volume of air remaining in the airways after a spontaneous expiration (not forced)	Baseline
Secondary	Age	Age	Baseline
Secondary	Weight	Weight	Baseline
Secondary	Sex	Sex	Baseline