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

NCT ID: NCT04022603

Last Updated: 2022-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-18

Study Completion Date

2020-08-03

Brief Summary

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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.

Detailed Description

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Conditions

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Hypoxemic Respiratory Failure

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Optiflow nasal googles

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

Group Type EXPERIMENTAL

Cyclometer Ergometer

Intervention Type 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.

Venturi mask

Oxygen provided by means of a Venturi mask.

Group Type ACTIVE_COMPARATOR

Cyclometer Ergometer

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dr David DE BELS

OTHER

Sponsor Role lead

Responsible Party

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Dr David DE BELS

Head of intensive care unit

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Sébastien Redant

Role: PRINCIPAL_INVESTIGATOR

CHU Brugmann

Locations

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CHU Brugmann

Brussels, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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CHUB-BPCO

Identifier Type: -

Identifier Source: org_study_id

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