Randomised double blind study to investigate the effect of oxygen versus air driven nebulisers on partial pressure of arterial carbon dioxide in patients with an exacerbation of chronic obstructive pulmonary disease.

In patients with an exacerbation of chronic obstructive pulmonary disease, a comparison between the effect of air versus oxygen driven nebulisers on the partial pressure of carbon dioxide.

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12615000389505

Enrollment

Registered

2015-04-28

Start date

2015-05-14

Completion date

2016-06-29

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

A parallel group double blinded randomised controlled trial comparing the effect of air versus oxygen driven bronchodilator nebulisation on PaCO2, pH and oxygen saturation (SpO2) in patients admitted to hospital with an acute exacerbation of COPD. Ninety patients will be recruited and randomised to receive two 15 minute administrations of salbutamol by nebulisation, delivered by air or oxygen at a flow rate of 8L/min

Interventions

Oxygen driven nebuliser regimen (all administered on a single occasion): a. t=0-15 min: 2.5 mg salbutamol by nebulisation, delivered by oxygen at a flow rate of 8L/min b. t=15-20 min: Removal of nebuliser mask c. t=20-35 min: 2.5 mg salbutamol by nebulisation, delivered by oxygen at a flow rate of 8L/min.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

40 Years to No maximum

Healthy volunteers

Inclusion criteria

i. Ninety patients admitted to Hutt Valley or Wellington Regional Hospital medical inpatient wards with a primary admission diagnosis of an exacerbation of COPD. ii. Participants must have the mental capacity to allow them to provide written informed consent.

Exclusion criteria

i. Age <40 years at time of randomisation ii. Requirement for assisted non-invasive ventilation at time of randomisation iii. Baseline PtCO2 >60mmHg at time of randomisation iv. Requirement for greater than or equal to 4L/min of oxygen via nasal cannulae to maintain SpO2 between 88-92% prior to or during titration v. 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 (including pregnancy or breastfeeding).

Outcome results