Skip to main content
Clinical Trials/NCT04022603
NCT04022603
Completed
Not Applicable

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

Dr David DE BELS1 site in 1 country30 target enrollmentAugust 18, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypoxemic Respiratory Failure
Sponsor
Dr David DE BELS
Enrollment
30
Locations
1
Primary Endpoint
Pulsated oxygen saturation (Sp02)
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 18, 2017
End Date
August 3, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Dr David DE BELS
Responsible Party
Sponsor Investigator
Principal Investigator

Dr David DE BELS

Head of intensive care unit

Brugmann University Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

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).

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.

Blood gasometry

Time Frame: 12 minutes (maximal effort)

Arterial blood analysis

Heart rate

Time Frame: 12 minutes (maximal effort)

The heart rate is the number of heartbeats per minute.

Respiratory rate

Time Frame: 12 minutes (maximal effort)

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

Mean arterial pressure

Time Frame: 12 minutes (maximal effort)

Mean arterial pressure

Systolic blood pressure

Time Frame: 12 minutes (maximal effort)

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

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).

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.

Functional residual capacity (CFR)

Time Frame: Baseline

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

Secondary Outcomes

  • Sex(Baseline)
  • Weight(Baseline)
  • Age(Baseline)

Study Sites (1)

Loading locations...

Similar Trials