High concentration oxygen in Chronic Obstructive Pulmonary Disease (COPD)

Response of Patients with COPD to Hyperoxia and Normoxia, as Measured by Carbon Dioxide Levels.

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000361606

Enrollment

Registered

2014-04-07

Start date

2014-06-10

Completion date

2015-01-21

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Oxygen may have the side effect of increasing the concentration of carbon dioxide in the blood. Carbon dioxide is a waste product that is removed from the body through the lungs. This side effect is known to occur in patients with COPD. To help understand how to best administer oxygen to patients we are interested in understanding how this effect occurs. We are also interested in whether patients with COPD have a different response to oxygen therapy compared with patients with other respiratory diseases (including bronchiectasis). To investigate this we will measure carbon dioxide levels in people with COPD while breathing room air and compare them to carbon dioxide levels after they have breathed oxygen. Following consent and assessment for eligibility, participants will be asked to breathe in random order treatment A (oxygen for 30 minutes) and treatment B (normal room air for 30 minutes) through a mask. Participants will be randomly assigned to either receive treatment A then treatment B, or treatment B then treatment A. Carbon dioxide is easily measured during the interventions using a small device clipped painlessly to the earlobe. This will allow for continuous monitoring of carbon dioxide levels by a study doctor The results of this study will then be compared with those from our recently completed study of oxygen in patients with bronchiectasis.

Interventions

50% oxygen administration for 30 minutes via a full-face continuous positive airway pressure mask without positive airway pressure. Followed by a 30 minute washout period.

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

16 Years to No maximum

Healthy volunteers

Inclusion criteria

COPD, as diagnosed by a doctor.

Exclusion criteria

1. Baseline transcutaneous carbon dioxide of greater than or equal to 60mmHg 2. FEV1:FVC ratio >0.7 3. Age under 16 years 4. A diagnosis of bronchiectasis 5. Morbid obesity (with a body mass index of greater than or equal to 40) 6. Inability to match FEV1 percentage predicted to a participant that took part in the bronchiectasis oxygen study* 7. Any other condition which, at the investigator’s discretion, is believed may present a safety risk or impact the feasibility of the study or the study results. *This study is designed to allow for comparison of results to a study of similar design in patients with bronchiectasis (ACTRN12612000356864). Participants will therefore be matched by FEV1 to the participants in the bronchiectasis study (the COPD participant must have an FEV1 percentage predicted within an absolute value of 5% of the FEV1 percentage predicted for the bronchiectasis patient (values inclusive)).

Outcome results