Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Sponsor ref: 5339
Study information
Scientific title
Acronym
PAWS 2
Study hypothesis
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
Ethics approval received from the Oxfordshire Research Ethics Committee A on the 10th Septermber 2007 (ref: 07/H0604/76).
Study design
An interventional un-blinded, randomised single centre study.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measure
Chest expansion (as a percentage of that achieved by the consultant paediatric anaesthetist, averaged over five breaths), measured at the time of the intervention.
Secondary outcome measures
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.
Overall trial start date
24/09/2007
Overall trial end date
24/12/2008
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
35 nurses, 105 children
Participant 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
Recruitment start date
24/09/2007
Recruitment end date
24/12/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Kadoorie Centre, Level 3
Oxford
OX3 9DU
United Kingdom
Sponsor information
Organisation
Oxford Radcliffe Hospitals NHS Trust (UK)
Sponsor details
Manor House
John Radcliffe Hospital
Headley Way
Oxford
OX39DU
United Kingdom
+44 (0)1865 222143
valerie.berry@orh.nhs.uk
Sponsor type
Government
Website
Funders
Funder type
Charity
Funder name
Resuscitation Council (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17635426
Publication citations
-
Results
Rechner JA, Loach VJ, Ali MT, Barber VS, Young JD, Mason DG, A comparison of the laryngeal mask airway with facemask and oropharyngeal airway for manual ventilation by critical care nurses in children., Anaesthesia, 2007, 62, 8, 790-795, doi: 10.1111/j.1365-2044.2007.05140.x.