Back to results

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

Primary Purpose

Dyspnea, Lung Diseases, Pulmonary Hypertension

Status

Terminated

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Automated nasal O2 titration with FreeO2

About this trial

This is an interventional supportive care trial for Dyspnea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Institut Universitaire de Cardiologie et de Pneumologie de Québec

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

automated nasal oxygen titration with FreeO2 alone

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

Fixed-flow oxygen therapy

Arm 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.

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.

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 .

Outcomes

Primary Outcome Measures

Dyspnea score

Dyspnea score on the modified Borg scale (0 to 10, with higher score indicating worse dyspnea)

Secondary Outcome Measures

Endurance time duration of the Endurance Shuttle Walking Test (EWST)

Total duration of Endurance Shuttle Walking Test

Mean pulsed O2 saturation (SpO2) during Endurance Shuttle Walking Test (EWST)

Mean % pulsed O2 saturation (SpO2) during the Endurance Shuttle Walking Test (ESWT)

Full Information

NCT ID

NCT05267418

First Posted

January 31, 2022

Last Updated

March 2, 2022

Sponsor

Laval University

1. Study Identification

Unique Protocol Identification Number

NCT05267418

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Terminated

Why Stopped

COVID19 pandemia

Study Start Date

February 26, 2019 (Actual)

Primary Completion Date

March 30, 2021 (Actual)

Study Completion Date

March 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Laval University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Participant

Masking Description

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

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

automated nasal oxygen titration with FreeO2 alone

Arm Type

Active Comparator

Arm Description

Arm Title

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

Arm Type

Active Comparator

Arm Description

Arm Title

Fixed-flow oxygen therapy

Arm Type

Active Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Automated nasal O2 titration with FreeO2

Other Intervention Name(s)

High O2 nasal flow with Airvo2, Fixed O2 flow

Intervention Description

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)

Primary Outcome Measure Information:

Title

Dyspnea score

Description

Dyspnea score on the modified Borg scale (0 to 10, with higher score indicating worse dyspnea)

Time Frame

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 Outcome Measure Information:

Title

Endurance time duration of the Endurance Shuttle Walking Test (EWST)

Description

Total duration of Endurance Shuttle Walking Test

Time Frame

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)

Title

Mean pulsed O2 saturation (SpO2) during Endurance Shuttle Walking Test (EWST)

Description

Mean % pulsed O2 saturation (SpO2) during the Endurance Shuttle Walking Test (ESWT)

Time Frame

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 Pre-specified Outcome Measures:

Title

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

Description

The mean % pulsed O2 saturation (SpO2) during the test duration time

Time Frame

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)

Title

Capillary blood gases

Description

Carbon dioxide partial pressure (PCO2), lactate

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Institut Universitaire de Cardiologie et de Pneumologie de Québec

City

Québec

State/Province

Quebec

ZIP/Postal Code

G1V4G5

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

30655277

Citation

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.

Results Reference

background

PubMed Identifier

32663102

Citation

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.

Results Reference

background

PubMed Identifier

19863362

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. doi: 10.1080/15412550903156317.

Results Reference

background

Learn more about this trial

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

We'll reach out to this number within 24 hrs