Which mask for facial oxygen at awake caesarean section?

ISRCTN ISRCTN60326156
DOI https://doi.org/10.1186/ISRCTN60326156
Secondary identifying numbers N0436160509
Submission date
30/09/2005
Registration date
30/09/2005
Last edited
13/10/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Gordon Lyons
Scientific

Labour Ward
Level 5
Gledhow Wing
Beckett Street
Leeds
LS9 7TF
United Kingdom

Phone +44 (0)113 206 5371 ext. 5371

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesThe aim of this study is to determine the efficiency of Hudson and Rebreathing oxygen facial mask in terms of fetal oxygen delivery.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedPregnancy and Childbirth: Anaesthesia
InterventionNot provided at time of registration
Intervention typeOther
Primary outcome measureThe oxygen of umbilical vein, and umbilical artery blood result observations are made by an independent observer (which is a routine procedure).
Secondary outcome measuresNot provided at time of registration
Overall study start date01/12/2004
Completion date01/05/2005

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participantsTotal Target Recruitment: 40
Key inclusion criteriaPatients requiring elective caesarean section under regional anaesthesia.
Key exclusion criteria1. ASA III
2. Failure to attain the level of block (touch to T5)
3. Any intravenous analgesia or anaesthesia are given before the birth of the child
Date of first enrolment01/12/2004
Date of final enrolment01/05/2005

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Labour Ward
Leeds
LS9 7TF
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Leeds Teaching Hospitals NHS Trust (UK)

No information available

NHS R&D Support Funding

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan