A comparison of the laryngeal mask airway with the oropharyngeal airway and facemask to achieve manual ventilation in children as performed by critical care and anaesthetic nurses

ISRCTN	ISRCTN38042170
DOI	https://doi.org/10.1186/ISRCTN38042170
Protocol serial number	Version 7
Sponsor	Oxford Radcliffe Hospitals NHS Trust (UK)
Funder	The Resuscitation Council UK

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr David Mason
Scientific

Nuffield Department of Anaesthetics
John Radcliffe Hospital
Headley Way
Oxford
OX3 9DU
United Kingdom

Primary study design	Interventional
Study design	Randomised, controlled, efficacy study
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	PAWS
Study objectives	Does the laryngeal mask airway (LMA) have a superior efficacy in achieving manual ventilation (breathing) compared with the current recommended technique for children who are not breathing, when used by critical care and anaesthetic nurses?
Ethics approval(s)	Approved by the Oxford Research Ethics Committee B on 17/08/2005, reference number: 05/Q1605/104
Health condition(s) or problem(s) studied	Children undergoing ASA I or II surgery or an MRI scan
Intervention	Insertion of a LMA airway versus oropharyngeal airway. Patients have both airways inserted, however the order of the insertion is randomised, immediately prior to inserting the airway, the nurse opens a sealed opaque envelope generated using a table of random numbers which states which airway should be inserted first.
Intervention type	Other
Primary outcome measure(s)	Chest excursion
Key secondary outcome measure(s)	1. Minute volume achieved by nurse and anaesthetist 2. Time to first breath 3. Mean inhaled and exhaled tidal volume
Completion date	01/09/2006

Participant type(s)	Patient
Age group	Child
Lower age limit	6 Months
Upper age limit	8 Years
Sex	All
Target sample size at registration	70
Key inclusion criteria	1. Patients aged between 6 months and 8 years scheduled for anaesthesiologists physical status (ASA) I and II surgery or a magnetic resonance imaging (MRI) scan 2. Patients who would routinely have an LMA inserted
Key exclusion criteria	1. Patients with an expected difficult airway 2. Patients with oesophageal reflux 3. Patients under 6 months 4. Patients 9 years or older
Date of first enrolment	01/09/2005
Date of final enrolment	01/09/2006

Nuffield Department of Anaesthetics

Oxford
OX3 9DU
United Kingdom

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/08/2007		Yes	No