A Study to Investigate the Effects of Oxygen in Obesity Hypoventilation Syndrome

A Randomised, Double-Blind, Cross-Over Study to Investigate the Effects of Hyperoxia on Carbon Dioxide Levels and Ventilation In Patients with Obesity Hypoventilation Syndrome

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12608000592347

Enrollment

Registered

2008-11-21

Start date

2008-07-01

Completion date

Unknown

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

Interventions

Subjects will be exposed to 2 interventions: 1. Inhaled 100% oxygen via a face mask for 20 minutes 2. Inhaled 21% oxygen via an identical facemask for 20 minutes. 3. There will be a wash out phase of at least 24 hours between the 2 interventions. 4. The two gases will be administered via douglas bags filled by 21% and 100% oxygen cylinders by a third party

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Educational / counselling / training

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

0 to No maximum

Healthy volunteers

Inclusion criteria

Patients with a new diagnosis of Obesity Hypoventilation Syndrome: 1. Body mass index (BMI) >30kg/m2, 2. Daytime hypercapnia (pCO2 >45mmHg)

Exclusion criteria

1. Diagnosis of chronic airflow obstruction: post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) to Forced Vital Capacity (FVC) ratio <0.7 and Forced Expiratory Volume in 1 second (FEV1) <80% predicted and > 10 pack year smoking history 2. Patients already receiving treatment with Continuous Positive Airway Pressure (CPAP) or non-invasive positive pressure ventilation

Outcome results