Effects of Automated Oxygen Titration Alone or With High Flow Nasal Therapy on Dyspnea and Exercise Tolerance

Laval University

Status: Terminated

Conditions: Dyspnea; Lung Diseases; Chronic Obstructive Pulmonary Disease; Cystic Fibrosis; Pulmonary Hypertension; Interstitial Lung Disease

Treatments: Device: Automated nasal O2 titration with FreeO2

Study type: Interventional

Funder types: Other

Identifiers

NCT05267418

21726

Details and patient eligibility

About

The main purpose of this study is to evaluate the effects of automated oxygen administration (FreeO2 system) alone or with high-flow oxygen on dyspnea and exercise tolerance in people with desaturating chronic lung disease compared to fixed oxygen therapy.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

One of them

• Moderate to severe COPD (forced expiratory volume in 1 second (FEV1) < 80% predicted and FEV1/forced vital capacity (FVC) ratio < 0.7)
• Chronic interstitial lung disease such as usual interstitial pneumonitis (UIP), non-specific interstitial pneumonitis (NSIP) or hypersensitivity pneumonitis on high-resolution computed tomography
• Pulmonary arterial hypertension type 1 or 4, excluding involvement secondary to collagenosis as well as secondary to congenital heart disease, as diagnosed with mean pulmonary artery pressure > 25 mm Hg at right heart catheterization
• Cystic fibrosis, as diagnosed by a positive sweat test (>60 mmol/L) or having 2 genetic mutations known to cause cystic fibrosis.

AND having a 6-minute walking test with significant desaturation defined as a decrease in O2 saturation greater or equal to 5% with O2 saturation at the end of the walking test < 88%

Exclusion criteria

• Exacerbation of the primary lung disease in the past 8 weeks
• Exercise limiting diseases other than the primary lung disease.
• Not reaching the target dyspnea score during the walking tests.
• Stage 1 pulmonary sarcoidosis
• History of syncope on exertion
• SpO2 with effort less than 90% despite the use of 6 L of O2 per minute
• Cardiac condition deemed unstable or severe (e.g. severe aortic stenosis)
• Disabling or severe rheumatological or neurological condition
• Participation in a pulmonary rehabilitation program within the last year
• Patients with multi-resistant bacteria

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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30 participants in 3 patient groups

automated nasal oxygen titration with FreeO2 alone

Active Comparator group

Description:

The participant received automated nasal oxygen titration administered by a closed loop system (FreeO2) during the 3-min constant speed shuttle test (3-min CSST) and endurance shuttle walking test (ESWT). The objective of this system is maintain SpO2 a the pre-specified target level (94% in this study) with an automatic adjustment of oxygen flow second by second.

Treatment:

Device: Automated nasal O2 titration with FreeO2

automated nasal oxygen titration with FreeO2 with high-flow nasal O2 therapy

Active Comparator group

Description:

In addition to nasal oxygen titration administered by a closed loop system (FreeO2), the participant received high flow nasal therapy (Airvo2) set at 60 liters per minute with nasal canula during the 3-min CSST and endurance shuttle walking test.

Treatment:

Device: Automated nasal O2 titration with FreeO2

Fixed-flow oxygen therapy

Active Comparator group

Description:

The participant received oxygen by nasal canula at a fixed flow of 2 liters per minute during the 3-min constant speed shuttle test (3-min CSST) and endurance shuttle walking test (ESWT). In patients already on home oxygen, the O2 flow during exercise was set at 1 L/min above the usual flow used at home .

Treatment:

Device: Automated nasal O2 titration with FreeO2