ISRCTN ISRCTN19789131
DOI https://doi.org/10.1186/ISRCTN19789131
Protocol serial number N0059185003
Sponsor Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Funders Sheffield Teaching Hospitals NHS Foundation Trust (UK), Own Account, NHS R&D Support Funding
Submission date
28/09/2007
Registration date
28/09/2007
Last edited
13/10/2011
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Ian Wrench
Scientific

STH NHS Foundation Trust
Anaesthetics
Royal Hallamshire Hospital
Sheffield
S10 2JF
United Kingdom

Phone +44 0114 271 2381
Email ian.wrench@sth.nhs.uk

Study information

Primary study designInterventional
Study designCrossover double blind randomised
Secondary study designRandomised controlled trial
Scientific title
Study objectivesTo determine how the circle anaesthetic breathing system can be used to achieve the highest possible oxygen levels in the lungs of pregnant patients during normal breathing.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedPregnancy and Childbirth: Anaesthesia
InterventionPreoxygenation vs standard treatment
Intervention typeDrug
PhaseNot Specified
Drug / device / biological / vaccine name(s)Preoxygenation
Primary outcome measure(s)

The FE02 achieved

Key secondary outcome measure(s)

Not provided at time of registration

Completion date30/09/2007

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target sample size at registration20
Key inclusion criteriaPregnant patients undergoing surgery under anaesthesia.
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/09/2006
Date of final enrolment30/09/2007

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

STH NHS Foundation Trust
Sheffield
S10 2JF
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/08/2008 Yes No