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

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.

Study Overview

• Status: Completed
• Conditions: Hypoxemic Respiratory Failure
• Intervention / Treatment: Device: Cyclometer Ergometer

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1020
    • CHU Brugmann

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Optiflow nasal googles; Oxygen provided by means of high throughput nasal googles (Optiflow, Fisher&Paykel- New Zealand).	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.
Active Comparator: Venturi mask; Oxygen provided by means of a Venturi mask.	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.

What is the study measuring?

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
Sex	Sex	Baseline
Weight	Weight	Baseline

Collaborators and Investigators

• Sponsor: Dr David DE BELS
• Investigators: Principal Investigator: Sébastien Redant, CHU Brugmann

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2017
• Primary Completion (Actual): August 3, 2020
• Study Completion (Actual): August 3, 2020

Study Registration Dates

• First Submitted: July 15, 2019
• First Submitted That Met QC Criteria: July 16, 2019
• First Posted (Actual): July 17, 2019

Study Record Updates

• Last Update Posted (Actual): March 4, 2022
• Last Update Submitted That Met QC Criteria: March 3, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: CHUB-BPCO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No