|
ISRCTN
|
ISRCTN60326156
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Which mask for facial oxygen at awake caesarean section?
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
N0436160509
|
|
Study hypothesis
|
The aim of this study is to determine the efficiency of Hudson and Rebreathing oxygen facial mask in terms of fetal oxygen delivery.
|
|
Ethics approval
|
Not provided at time of registration
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Pregnancy and Childbirth: Anaesthesia
|
|
Participants - inclusion criteria
|
Patients requiring elective caesarean section under regional anaesthesia.
|
|
Participants - exclusion criteria
|
1. 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
|
|
Anticipated start date
|
01/12/2004
|
|
Anticipated end date
|
01/05/2005
|
|
Status of trial
|
Completed
|
|
Patient information material
|
|
|
Target number of participants
|
Total Target Recruitment: 40
|
|
Interventions
|
Not provided at time of registration
|
|
Primary outcome measure(s)
|
The oxygen of umbilical vein, and umbilical artery blood result observations are made by an independent observer (which is a routine procedure).
|
|
Secondary outcome measure(s)
|
Not provided at time of registration
|
|
Sources of funding
|
Leeds Teaching Hospitals NHS Trust (UK)
NHS R&D Support Funding
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Dr
Gordon
Lyons
|
|
Address
|
Labour Ward
Level 5
Gledhow Wing
Beckett Street
|
|
City/town
|
Leeds
|
|
Zip/Postcode
|
LS9 7TF
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)113 206 5371 ext. 5371
|
|
Fax
|
+44 (0)113 242 6496
|
|
Email
|
Gordon.Lyons@leedsth.nhs.uk
|
|
Sponsor
|
Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)
|
|
Address
|
The Department of Health, Richmond House, 79 Whitehall
|
|
City/town
|
London
|
|
Zip/Postcode
|
SW1A 2NL
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)20 7307 2622
|
|
Email
|
dhmail@doh.gsi.org.uk
|
|
Sponsor website:
|
http://www.dh.gov.uk/Home/fs/en
|
|
Date applied
|
30/09/2005
|
|
Last edited
|
26/06/2008
|
|
Date ISRCTN assigned
|
30/09/2005
|