Condition category
Surgery
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
21/07/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Andy Ball

ORCID ID

Contact details

West Dorset General Hospitals NHS Trust
Dorset County Hospital
Williams Avenue
Dorchester
DT1 2JY
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0391148230

Study information

Scientific title

Acronym

Study hypothesis

Null hypothesis: that there will be no difference in the expired oxygen concentration.

Ethics approval

Not provided at time of registration

Study design

Cross over randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Surgery: Anaesthesia

Intervention

20 to 30 subjects randomised into 2 groups. Each group will undergo 2 cycles of 3 minutes preoxygenation with each of the test masks, attached to the same anaesthetic circuit.

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

1. Comparison of area under the curve for expired oxygen concentration against time over 3 minutes.
2. Comparison of inspired oxygen concentrations against time over the 3 minutes.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/09/2004

Overall trial end date

31/03/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Between 20-30 subjects recruited from non-anaesthetic colleagues.

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

30 healthy volunteers recruited from colleagues

Participant exclusion criteria

Respiratory disease, significant cardiac disease.

Recruitment start date

01/09/2004

Recruitment end date

31/03/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

West Dorset General Hospitals NHS Trust
Dorchester
DT1 2JY
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

West Dorset General Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17444313

Publication citations

  1. Results

    Ball AJ, Craig J, Green RJ, Richardson DJ, Performance comparison of two anaesthetic facemasks., Anaesth Intensive Care, 2007, 35, 2, 226-229.

Additional files

Editorial Notes