Condition category
Surgery
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
17/12/2008
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 D Laws

ORCID ID

Contact details

Department of Anaesthesia
Sunderland Royal Hospital
Kayll Road
Sunderland
SR4 7TP
United Kingdom
+44 (0)191 5656256 ext 42446

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0065101825

Study information

Scientific title

Acronym

Study hypothesis

Does positioning a patient in a reclined versus a supine position before pre-oxygenation improve the efficacy of this process? Primary null hypothesis is that positioning a patient 20 head-up will not effect the efficacy of pre-oxygenation.

Ethics approval

Not provided at time of registration

Study design

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: Cholecystomy

Intervention

20 women will be randomised to receive oxygen in the usual way.
20 women will receive oxygen in a slightly reclined position.

Monitors will be used to determine which group of patients demonstrates the most oxygen stored in their body. Patients will be connected to a breathing machine via a tube placed in their throat after they are asleep. The study also aims to investigate which position (lying flat or slightly reclined) provides the best view of the patient's throat when placing the tube.

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/11/2001

Overall trial end date

01/09/2003

Reason abandoned

Eligibility

Participant inclusion criteria

40 female patients undergoing cholecystomy.

Participant type

Patient

Age group

Not Specified

Gender

Female

Target number of participants

40

Participant exclusion criteria

Pregnant patients will be excluded.

Recruitment start date

01/11/2001

Recruitment end date

01/09/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Anaesthesia
Sunderland
SR4 7TP
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

City Hospitals Sunderland NHS Trust (UK)

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

2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16229689

Publication citations

  1. Results

    Lane S, Saunders D, Schofield A, Padmanabhan R, Hildreth A, Laws D, A prospective, randomised controlled trial comparing the efficacy of pre-oxygenation in the 20 degrees head-up vs supine position., Anaesthesia, 2005, 60, 11, 1064-1067, doi: 10.1111/j.1365-2044.2005.04374.x.

Additional files

Editorial Notes