High concentration oxygen in Chronic Obstructive Pulmonary Disease (COPD): Study 2

Response of Patients with COPD to Hyperoxia and Normoxia, as Measured by Carbon Dioxide Levels: Study 2

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12615001056583

Enrollment

Registered

2015-10-07

Start date

2016-01-28

Completion date

2017-05-18

Last updated

2021-06-14

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

Conditions

None listed

Brief summary

This study directly relates to the trial ACTRN12614000361606. As there is concern regarding the accuracy of the data collected by the specific transcutaneous probes used with that study (measuring carbon dioxide, oxygen levels and heart rate), the study is being repeated using a Sentec transcutaneous monitor. The Ethics approval number and UTN remain the same, however ANZCTR required a new trial registration number. Two new outcome measures have been added (end tidal carbon dioxide, to further assess the mechanisms behind any change in carbon dioxide, and drift corrected carbon dioxide (a function of the Sentec monitor to improve accuracy)). In addition, an arteriolised blood gas will be performed at the end of the study to validate the Sentec. Oxygen therapy has been shown to increase carbon dioxide in the blood of patients with certain respiratory conditions. This study aims to find out if oxygen therapy increases carbon dioxide levels in patients with COPD, and compare data to that from patients with bronchiectasis or cystic fibrosis.

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)

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 (ACTRN12615000971538). 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)). An exception to this is for the three bronchiectasis participants that had FEV1 percentage predicted values of 109% or higher, who are to be matched with COPD participants with an FEV1 percent predicted of 80% or over (i.e. participants in the mildest COPD severity category based on FEV1).

Outcome results