| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN60326156 |
| Date ISRCTN assigned | 30/09/2005 |
| Local reference number(s) | N0436160509 |
| Public title | Which mask for facial oxygen at awake caesarean section? |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Pregnancy and Childbirth: Anaesthesia |
| 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 |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | To enrol the patient 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 |
| Patient information material |
|
| Anticipated start date | 01/12/2004 |
| Anticipated end date | 01/05/2005 |
| Status of trial | Completed |
| Target number of participants | Total Target Recruitment: 40 |
| Interventions | Randomised controlled trial
|
| 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) | See Primary outcome measures |
| Sources of funding | Leeds Teaching Hospitals NHS Trust
NHS R&D Support Funding |
| Sponsor name | Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK) |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Dr Gordon Lyons |
| Contact details | Labour Ward
Level 5
Gledhow Wing
Beckett Street
Leeds
United Kingdom
LS9 7TF |
| Contact telephone | +44 (0)113 206 5371 ext. 5371 |
| Contact fax | +44 (0)113 242 6496 |
| Contact email | Gordon.Lyons@leedsth.nhs.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN60326156 |
| Date last extracted from ISRCTN register | 17/04/2008 |
