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

Not Applicable

Terminated

• Conditions: Dyspnea; Lung Diseases; Pulmonary Hypertension; Chronic Obstructive Pulmonary Disease; Cystic Fibrosis; Interstitial Lung Disease
• Interventions: Device: Automated nasal O2 titration with FreeO2

• Registration Number: NCT05267418
• Lead Sponsor: Laval University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-26
• Primary Completion: 2021-03-30
• Study Completion: 2021-03-30
• Study First Submitted: 2022-01-31
• Status Verified: 2022-03
• Study First Submitted QC: 2022-03-02
• Last Update Submitted: 2022-03-02
• Study First Posted: 2022-03-04
• Last Update Posted: 2022-03-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Fixed-flow oxygen therapy	Automated nasal O2 titration with FreeO2	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 .
automated nasal oxygen titration with FreeO2 alone	Automated nasal O2 titration with FreeO2	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.
automated nasal oxygen titration with FreeO2 with high-flow nasal O2 therapy	Automated nasal O2 titration with FreeO2	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.

Primary Outcome Measures

Name	Time	Method
Dyspnea score	At the end of the 3 minute-constant speed shuttle test (CSST) (3 minutes), immediately after the intervention (either fixed-O2, automated nasal O2 adjustment alone, or automated nasal O2 adjustment + high nasal flow)	Dyspnea score on the modified Borg scale (0 to 10, with higher score indicating worse dyspnea)

Secondary Outcome Measures

Name	Time	Method
Endurance time duration of the Endurance Shuttle Walking Test (EWST)	Duration in (mm:ss) of Endurance Shuttle Walking Test (ESWT), immediately after the intervention (either fixed-O2, automated nasal O2 adjustment alone, or automated nasal O2 adjustment + high nasal flow)	Total duration of Endurance Shuttle Walking Test
Mean pulsed O2 saturation (SpO2) during Endurance Shuttle Walking Test (EWST)	From the beginning to the end of the Endurance Shuttle Walking Test (ESWT) which will be done on 3 testing days, with either fixed O2, automatic O2 adjustment alone, or automatic O2 adjustment + high nasal flow	Mean % pulsed O2 saturation (SpO2) during the Endurance Shuttle Walking Test (ESWT)

Trial Locations

Locations (1)

Institut Universitaire de Cardiologie et de Pneumologie de Québec; 🇨🇦 Québec, Quebec, Canada