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

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

TERMINATED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-26

Study Completion Date

2021-03-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Dyspnea Lung Diseases Pulmonary Hypertension Chronic Obstructive Pulmonary Disease Cystic Fibrosis Interstitial Lung Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

The participant was not inform about what kind of oxygen support was provided during exercise

Study Groups

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automated nasal oxygen titration with FreeO2 alone

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.

Group Type ACTIVE_COMPARATOR

Automated nasal O2 titration with FreeO2

Intervention Type DEVICE

The participant received, in a randomized, cross-over study design: 1) automated nasal oxygen titration administered by a closed loop system (FreeO2) alone, 2) or with high flow nasal therapy (Airvo2) set at 60 liters per minute with nasal canula, or 3) 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)

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

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.

Group Type ACTIVE_COMPARATOR

Automated nasal O2 titration with FreeO2

Intervention Type DEVICE

The participant received, in a randomized, cross-over study design: 1) automated nasal oxygen titration administered by a closed loop system (FreeO2) alone, 2) or with high flow nasal therapy (Airvo2) set at 60 liters per minute with nasal canula, or 3) 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)

Fixed-flow oxygen therapy

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 .

Group Type ACTIVE_COMPARATOR

Automated nasal O2 titration with FreeO2

Intervention Type DEVICE

The participant received, in a randomized, cross-over study design: 1) automated nasal oxygen titration administered by a closed loop system (FreeO2) alone, 2) or with high flow nasal therapy (Airvo2) set at 60 liters per minute with nasal canula, or 3) 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)

Interventions

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Automated nasal O2 titration with FreeO2

The participant received, in a randomized, cross-over study design: 1) automated nasal oxygen titration administered by a closed loop system (FreeO2) alone, 2) or with high flow nasal therapy (Airvo2) set at 60 liters per minute with nasal canula, or 3) 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)

Intervention Type DEVICE

Other Intervention Names

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High O2 nasal flow with Airvo2 Fixed O2 flow

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No