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

NCT05267418 | Terminated

• 1 other identifier: 21726
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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)

• 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

Other Outcomes (2)

• Mean pulsed O2 saturation (SpO2) during 3min-CSST

  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)

• Capillary blood gases

  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

Study Arms (3)

automated nasal oxygen titration with FreeO2 alone

ACTIVE COMPARATOR

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.

Device: Automated nasal O2 titration with FreeO2

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

ACTIVE COMPARATOR

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.

Device: Automated nasal O2 titration with FreeO2

Fixed-flow oxygen therapy

ACTIVE COMPARATOR

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 .

Device: Automated nasal O2 titration with FreeO2

Interventions

Automated nasal O2 titration with FreeO2 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)

Also known as: High O2 nasal flow with Airvo2, Fixed O2 flow

Fixed-flow oxygen therapy; automated nasal oxygen titration with FreeO2 alone; automated nasal oxygen titration with FreeO2 with high-flow nasal O2 therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Laval University: lead

Study Sites (1)

Institut Universitaire de Cardiologie et de Pneumologie de Québec

Québec, Quebec, G1V4G5, Canada

Location

Related Publications (3)

• Maltais F, Aumann JL, Kirsten AM, Nadreau E, 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):1802049. doi: 10.1183/13993003.02049-2018. Print 2019 Mar.

  PMID: 30655277 BACKGROUND

• Beaulieu J, Jensen D, O'Donnell DE, Brouillard C, Tracey L, Vincent S, Nadreau E, 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.

  PMID: 32663102 BACKGROUND

• 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. doi: 10.1080/15412550903156317.

  PMID: 19863362 BACKGROUND

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hypertension; Vascular Diseases; Cardiovascular Diseases; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pancreatic Diseases; Digestive System Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participant was not inform about what kind of oxygen support was provided during exercise
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 31, 2022
• First Posted: March 4, 2022
• Study Start: February 26, 2019
• Primary Completion: March 30, 2021
• Study Completion: March 30, 2021
• Last Updated: March 4, 2022

Record last verified: 2022-03

Locations

CA (1)