A comparison of the laryngeal mask airway (LMA) with the facemask and oropharyngeal airway for manual ventilation by PAediatric Ward nurseS in children

ISRCTN	ISRCTN38888037
DOI	https://doi.org/10.1186/ISRCTN38888037
Protocol serial number	Sponsor ref: 5339
Sponsor	Oxford Radcliffe Hospitals NHS Trust (UK)
Funder	Resuscitation Council (UK)

Submission date: 07/11/2007
Registration date: 03/04/2008
Last edited: 28/03/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Jennie Rechner
Scientific

Kadoorie Centre, Level 3
John Radcliffe Hospital
Headley Way
Oxford
OX3 9DU
United Kingdom

Study information

Primary study design	Interventional
Study design	An interventional un-blinded, randomised single centre study.
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title
Study acronym	PAWS 2
Study objectives	Does the laryngeal mask airway (LMA) have a superior efficacy to achieve manual ventilation compared with the current recommended technique (the oro-pharyngeal airway and face mask) for children who are not breathing when used by paediatric ward nurses? Please note that this trial is a follow-on from the previously registered trial ISRCTN38042170 - 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 (see http://www.controlled-trials.com/ISRCTN38042170), which investigates the LMA used by critical care and anaesthetic nurses.
Ethics approval(s)	Ethics approval received from the Oxfordshire Research Ethics Committee A on the 10th Septermber 2007 (ref: 07/H0604/76).
Health condition(s) or problem(s) studied	Manual ventilation
Intervention	The child would be anaesthetised in a standard way by a consultant anaesthetist. Once asleep the paediatric ward nurse would insert each airway device in random order and manually ventilate the lungs for a minimum of five breaths. Ventilation would be measured by an ultrasonic displacement device sited over the chest and compared to that achieved by the consultant paediatric anaesthetist. There is no follow up after the intervention.
Intervention type	Other
Primary outcome measure(s)	Chest expansion (as a percentage of that achieved by the consultant paediatric anaesthetist, averaged over five breaths), measured at the time of the intervention.
Key secondary outcome measure(s)	1. To assess the effectiveness of ventilation by paediatric ward nurses when using the facemask and oropharyngeal airway 2. To assess whether the paediatric ward nurses can be trained to successfully place the laryngeal mask airway in anaesthetised children after mannikin training 3. To assess whether a learning curve exists for successful insertion of the laryngeal mask airway 4. To compare the time taken to successful ventilation using both airway devices All outcomes will be measured at the time of the intervention.
Completion date	24/12/2008

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	6 Months
Upper age limit	8 Years
Sex	All
Target sample size at registration	105
Key inclusion criteria	1. All children aged 6 months to 8 years, scheduled for elective surgery or a magnetic resonance imaging (MRI) scan in which a laryngeal mask airway would be placed routinely 2. Paediatric ward nurses
Key exclusion criteria	1. Children in whom a laryngeal mask airway is contradicted, e.g., gastro-oesophageal reflux disease, known difficult airway or obesity 2. Children outside the inclusion age range
Date of first enrolment	24/09/2007
Date of final enrolment	24/12/2008

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Kadoorie Centre, Level 3

Oxford
OX3 9DU
United Kingdom

Results and Publications

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/08/2007		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes