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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Effects of Automated Oxygen Titration Alone or With High Flow Nasal Therapy on Dyspnea and Exercise Tolerance in Patients With Desaturating Chronic Lung Disease: a Randomized Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05267418
• Other study ID #: 21726
• Status: Terminated
• Phase: N/A
• Start date: February 26, 2019
• Est. completion date: March 30, 2021

Study information

• Verified date: March 2022
• Source: Laval University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: March 30, 2021
• Est. primary completion date: March 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• 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)

Locations

Country	Name	City	State
Canada	Institut Universitaire de Cardiologie et de Pneumologie de Québec	Québec	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Laval University

Country where clinical trial is conducted

Canada, 

References & Publications (3)

Beaulieu J, Jensen D, O'Donnell DE, Brouillard C, Tracey L, Vincent S, Nadreau É, Bernard E, Bernard S, Maltais F. Relieving exertional dyspnea during the 3-min constant speed shuttle test in patients with COPD with indacaterol/glycopyrronium versus tiotropium: the RED trial. Ther Adv Respir Dis. 2020 Jan-Dec;14:1753466620939507. doi: 10.1177/1753466620939507. — View Citation

Maltais F, Aumann JL, Kirsten AM, Nadreau É, Macesic H, Jin X, Hamilton A, O'Donnell DE. Dual bronchodilation with tiotropium/olodaterol further reduces activity-related breathlessness versus tiotropium alone in COPD. Eur Respir J. 2019 Mar 28;53(3). pii: 1802049. doi: 10.1183/13993003.02049-2018. Print 2019 Mar. — View Citation

Perrault H, Baril J, Henophy S, Rycroft A, Bourbeau J, Maltais F. Paced-walk and step tests to assess exertional dyspnea in COPD. COPD. 2009 Oct;6(5):330-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mean pulsed O2 saturation (SpO2) during 3min-CSST	The mean % pulsed O2 saturation (SpO2) during the test duration time	From the beginning to the end of the 3 minute-constant speed shuttle test which will be done on 3 testing days with either fixed O2, automatic O2 adjustment alone, or automatic O2 adjustment + high nasal flow)
Other	Capillary blood gases	Carbon dioxide partial pressure (PCO2), lactate	Difference the baseline capillary PCO2 from the resting values (before Endurance Shuttle Walking Test - ESWT) to the end of exercise values (after the Endurance Shuttle Walking Test - ESWT) immediately after the intervention
Primary	Dyspnea score	Dyspnea score on the modified Borg scale (0 to 10, with higher score indicating worse dyspnea)	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)
Secondary	Endurance time duration of the Endurance Shuttle Walking Test (EWST)	Total duration of Endurance Shuttle Walking Test	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)
Secondary	Mean pulsed O2 saturation (SpO2) during Endurance Shuttle Walking Test (EWST)	Mean % pulsed O2 saturation (SpO2) during the Endurance Shuttle Walking Test (ESWT)	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