Which mask for facial oxygen at awake caesarean section?

ISRCTN	ISRCTN60326156
DOI	https://doi.org/10.1186/ISRCTN60326156
Protocol serial number	N0436160509
Sponsor	Department of Health
Funders	Leeds Teaching Hospitals NHS Trust (UK), NHS R&D Support Funding

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

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Pregnancy and Childbirth: Anaesthesia
Intervention	Not provided at time of registration
Intervention type	Other
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).
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/05/2005

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	40
Key inclusion criteria	Patients requiring elective caesarean section under regional anaesthesia.
Key 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
Date of first enrolment	01/12/2004
Date of final enrolment	01/05/2005

Labour Ward

Leeds
LS9 7TF
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan