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NCT Number: NCT04022603

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.

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Key information

Conditions

Hypoxemic Respiratory Failure Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Brugmann

Brussels, 1020, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cyclometer Ergometer

Device

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.

Primary outcomes

  1. Pulsated oxygen saturation (Sp02)

    Time frame: Baseline

    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).

  2. Pulsated oxygen saturation (Sp02)

    Time frame: 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).

  3. Oxygen inspired fraction (FiO2)

    Time frame: Baseline

    Oxygen inspired fraction (FiO2) is the fraction or percentage of oxygen present in the gas mixture that a person breathes.

  4. Oxygen inspired fraction (FiO2)

    Time frame: 12 minutes (maximal effort)

    Oxygen inspired fraction (FiO2) is the fraction or percentage of oxygen present in the gas mixture that a person breathes.

  5. Blood gasometry

    Time frame: Baseline

    Arterial blood analysis

  6. Blood gasometry

    Time frame: 12 minutes (maximal effort)

    Arterial blood analysis

  7. Heart rate

    Time frame: Baseline

    The heart rate is the number of heartbeats per unit minute.

  8. Heart rate

    Time frame: 12 minutes (maximal effort)

    The heart rate is the number of heartbeats per minute.

  9. Respiratory rate

    Time frame: Baseline

    Number of breath cycles (inspiration and expiration) per minute.

  10. Respiratory rate

    Time frame: 12 minutes (maximal effort)

    Number of breath cycles (inspiration and expiration) per minute.

  11. Mean arterial pressure

    Time frame: Baseline

    Mean arterial pressure

  12. Mean arterial pressure

    Time frame: 12 minutes (maximal effort)

    Mean arterial pressure

  13. Systolic blood pressure

    Time frame: Baseline

    Systolic blood pressure (pressure in the artery as the heart contracts)

  14. Systolic blood pressure

    Time frame: 12 minutes (maximal effort)

    Systolic blood pressure (pressure in the artery as the heart contracts)

  15. Borg score

    Time frame: 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).

  16. Forced expiratory volume per second (FEV1)

    Time frame: 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.

  17. Functional residual capacity (CFR)

    Time frame: Baseline

    Volume of air remaining in the airways after a spontaneous expiration (not forced)

Secondary outcomes

  1. Age

    Time frame: Baseline

    Age

  2. Weight

    Time frame: Baseline

    Weight

  3. Sex

    Time frame: Baseline

    Sex

Sponsors and collaborators

Lead sponsor

Dr David DE BELS

Other

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jul 17, 2019
Registry last updated
Mar 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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