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ISRCTN
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ISRCTN38888037
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ClinicalTrials.gov identifier
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Public title
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A comparison of the laryngeal mask airway (LMA) with the facemask and oropharyngeal airway for manual ventilation by PAediatric Ward nurseS in children
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Scientific title
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Acronym
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PAWS 2
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Serial number at source
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Sponsor ref: 5339
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Study hypothesis
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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.
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Ethics approval
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Ethics approval received from the Oxfordshire Research Ethics Committee A on the 10th Septermber 2007 (ref: 07/H0604/76).
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Study design
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An interventional un-blinded, randomised single centre study.
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Manual ventilation
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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24/09/2007
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Anticipated end date
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24/12/2008
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Status of trial
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Ongoing
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Patient information material
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Target number of participants
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35 nurses, 105 children
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Interventions
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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.
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Primary outcome measure(s)
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Chest expansion (as a percentage of that achieved by the consultant paediatric anaesthetist, averaged over five breaths), measured at the time of the intervention.
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Secondary outcome measure(s)
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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.
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Sources of funding
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Resuscitation Council (UK)
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Trial website
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Publications
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Contact name
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Dr
Jennie
Rechner
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Address
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Kadoorie Centre, Level 3
John Radcliffe Hospital
Headley Way
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City/town
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Oxford
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Zip/Postcode
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OX3 9DU
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Country
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United Kingdom
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Sponsor
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Oxford Radcliffe Hospitals NHS Trust (UK)
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Address
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Manor House
John Radcliffe Hospital
Headley Way
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City/town
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Oxford
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Zip/Postcode
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OX39DU
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Country
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United Kingdom
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Tel
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+44 (0)1865 222143
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Email
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valerie.berry@orh.nhs.uk
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Sponsor website:
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http://www.oxfordradcliffe.nhs.uk/home.aspx
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Date applied
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07/11/2007
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Last edited
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03/04/2008
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Date ISRCTN assigned
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03/04/2008
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