High Concentration Oxygen in Neuromuscular Disease: Study 2

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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12615000970549

Enrollment

Registered

2015-09-16

Start date

2015-10-13

Completion date

2017-05-30

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 ACTRN12612000393853. 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)). 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 neuromuscular disease and, if so, how.

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

14 Years to No maximum

Healthy volunteers

Inclusion criteria

Diagnosis of neuromuscular disease with a greater than or equal to 10% drop in vital capacity from standing to lying, or a sniff nasal inspiratory pressure under the lower limit (above which lie 95% of healthy subjects), based on work by Uldry and Fitting (Thorax 1995;50(4)). OR Kyphoscoliosis with an FVC <65% predicted.

Exclusion criteria

Baseline transcutaneous carbon dioxide of greater than or equal to 60mmHg Diagnosis of chronic obstructive pulmonary disease FEV1:FVC ratio less than or equal to 70% (if participant able to perform forced spirometry) Obesity (with a body mass index of greater than or equal to 40) 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.

Outcome results