NCT04022603

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 18, 2017

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

July 15, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 17, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 3, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 3, 2020

Completed
Last Updated

March 4, 2022

Status Verified

March 1, 2022

Enrollment Period

3 years

First QC Date

July 15, 2019

Last Update Submit

March 3, 2022

Conditions

Hypoxemic Respiratory Failure

Outcome Measures

Primary Outcomes (17)

  • 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 Outcomes (3)

  • Age

    Baseline

  • Weight

    Baseline

  • Sex

    Baseline

Study Arms (2)

Optiflow nasal googles

EXPERIMENTAL

Oxygen provided by means of high throughput nasal googles (Optiflow, Fisher\&Paykel- New Zealand).

Device: Cyclometer Ergometer

Venturi mask

ACTIVE COMPARATOR

Oxygen provided by means of a Venturi mask.

Device: Cyclometer Ergometer

Interventions

Cyclometer ErgometerDEVICE

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.

Optiflow nasal googlesVenturi mask

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Acute respiratory insufficiency type I, oxygen partial pressure (PaO2) \<60 mmHg under oxygen without hypercapnia.
  • Invasive arterial pressure measure

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Brugmann

Brussels, 1020, Belgium

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Officials

  • Sébastien Redant

    CHU Brugmann

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of intensive care unit

Study Record Dates

First Submitted

July 15, 2019

First Posted

July 17, 2019

Study Start

August 18, 2017

Primary Completion

August 3, 2020

Study Completion

August 3, 2020

Last Updated

March 4, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)