Automated Oxygen Titration During Walking in Patients With COPD

NCT04123730 | Completed DMC

• 1 other identifier: H-19044780
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose: to evaluate the immediate effect of automated oxygen titration compared to usual fixed-dose oxygen treatment during exercise in patients with COPD on long-term oxygen treatment. Methods: The study will be conducted as a double blinded randomized crossover trial with two arms. 40 ambulatory patients with COPD and home oxygen treatment will be included from AHH Hospital's catchment area. The patients will conduct two Endurance Shuttle Walk Tests (ESWT) in a crossover design using an O2matic device to deliver a variable oxygen dosage set at an SpO2-target of 90-94% and an O2-flow of 0 - 15 liters/min and using the patients´ usual fixed-dose oxygen delivery, in a randomized order. In both arms O2matic will monitor pulse rate and SpO2 continuously during the test, but only in the automated oxygen titration arm will O2matic adjust oxygen flow. The patient and the physiotherapist supervising the tests will be blinded to the oxygen dose. Primary outcome is the changes in perceived dyspnea intensity using Borg CR10 scale between walking with automated titration compared to fixed-dose treatment. Secondary outcomes are differences in walking time, the average oxygen consumption between automated oxygen titration and fixed-dose treatment and difference in time spent within acceptable SpO2-interval.

Conditions

Chronic Obstructive Pulmonary Disease; Respiratory Failure

Keywords

Long Term Oxygen Treatment; Dyspnea; Physiotherapy

Outcome Measures

Primary Outcomes (1)

• Perceived dyspnea intensity using Borg CR10 dyspnea scale

  Difference in Dyspnea Borg CR10 (from 0-10) scores in the ESWT at isotimes (every minute) in both tests walking with automated titration compared to fixed-dose treatment. The Borg scale starts at number 0 where your breathing is causing the patient no difficulty at all and progresses through to number 10 where the breathing difficulty is maximal

  Twenty minutes

Secondary Outcomes (4)

• Walking time

  Twenty minutes

• Time with Hypoxemia

  Twenty minutes

• Average numbers of liter oxygen per minutes

  Twenty minutes

• Walking distance in meters

  six minutes

Study Arms (2)

Fixed dose oxygen

ACTIVE COMPARATOR

O2Matic deliver the usual fixed-dose oxygen treatment during walking.

Other: Fixed-dose compared to variable oxygen flow supplementation during walking

Automated oxygen titration

EXPERIMENTAL

O2Matic deliver a variable oxygen dosage set at an SpO2-target of 90 to 94 % and a O2-flow of 0 - 15 liters/min during walking.

Other: Fixed-dose compared to variable oxygen flow supplementation during walking

Interventions

Fixed-dose compared to variable oxygen flow supplementation during walking OTHER

At day 1 the patients will perform Walk A and Walk B in a random order: Walk A: The patients will perform a Endurance Shuttle Walk Tests (ESWT) with the fixed-dose (FOT). O2matic will monitor pulse rate and saturation continuously during the test. Walk B: The patients will perform a Endurance Shuttle Walk Tests (ESWT) with a variable oxygen flow (AOT) depending on the saturation. O2matic will monitor pulse rate and saturation continuously during the test, and adjust oxygen flow depending on the saturation. At day 2 the patients will perform two 6 minutes walking (MWT) test in random order: Walk C: A 6 MWT with FOT Walk D; A 6 MWT with AOT

Automated oxygen titration; Fixed dose oxygen

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Verified history of COPD with FEV1/FVC \< 0,70
• Hypoxemic at rest (SpO2 ≤ 90 %) and fulfilment of criteria for LTOT
• Able to walk at least 70 meters
• Cognitively able to participate in the study and willing to give informed consent

You may not qualify if:

• Pulmonary or cardiac condition other than COPD limiting exercise performance
• Unstable heart condition or stenotic aortic valve disease
• A physical condition including paralysis, lower extremity pain, or back problem limiting exercise performance
• Exacerbation in COPD treated with either antibiotics or prednisolone within the last 3 weeks

Sponsors & Collaborators

• Hvidovre University Hospital: lead
• Region Örebro County: collaborator
• Aalborg University Hospital: collaborator
• Danmarks Lungeforening: collaborator

Study Sites (1)

Copenhagen University Hospital, Hvidovre

Hvidovre, 2650, Denmark

Location

Related Publications (2)

• O'Driscoll BR, Howard LS, Earis J, Mak V; British Thoracic Society Emergency Oxygen Guideline Group; BTS Emergency Oxygen Guideline Development Group. BTS guideline for oxygen use in adults in healthcare and emergency settings. Thorax. 2017 Jun;72(Suppl 1):ii1-ii90. doi: 10.1136/thoraxjnl-2016-209729. No abstract available.

  PMID: 28507176 BACKGROUND

• Hansen EF, Hove JD, Bech CS, Jensen JS, Kallemose T, Vestbo J. Automated oxygen control with O2matic(R) during admission with exacerbation of COPD. Int J Chron Obstruct Pulmon Dis. 2018 Dec 14;13:3997-4003. doi: 10.2147/COPD.S183762. eCollection 2018.

  PMID: 30587955 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Respiratory Insufficiency; Dyspnea

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• Linette Marie Kofod, PT

  Hvidovre University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The patient will be blinded for the oxygen supply. An independent person will prepare the oxygen setup with O2matic in manual mode for fixed dose oxygen and in automatic mode for automated oxygen titration. The assessor conducting the walking test is blinded.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Model Details: randomised crossover trial

Study Record Dates

• First Submitted: October 9, 2019
• First Posted: October 11, 2019
• Study Start: October 28, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: June 30, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 01.01.2023
• Access Criteria: Se Plan Description

Locations

DK (1)