| Source of record | UK Trials |
| ISRCTN | ISRCTN38888037 |
| Date ISRCTN assigned | 03/04/2008 |
| Local reference number(s) | Sponsor ref: 5339 |
| Public title | A comparison of the laryngeal mask airway (LMA) with the facemask and oropharyngeal airway for manual ventilation by PAediatric Ward nurseS in children |
| Scientific title |
|
| Acronym | PAWS 2 |
| Disease/condition/study domain | Manual ventilation |
| 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. |
| Design/methodology | An interventional un-blinded, randomised single centre study. |
| Research ethics review | Ethics approval received from the Oxfordshire Research Ethics Committee A on the 10th Septermber 2007 (ref: 07/H0604/76). |
| Countries of trial | United Kingdom |
| Participants - 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 |
| Participants - 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 |
| Patient information material |
|
| Anticipated start date | 24/09/2007 |
| Anticipated end date | 24/12/2008 |
| Status of trial | Ongoing |
| Target number of participants | 35 nurses, 105 children |
| Interventions | 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. |
| 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. |
| 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. |
| Sources of funding | Resuscitation Council (UK) |
| Sponsor name | Oxford Radcliffe Hospitals NHS Trust (UK) |
| Sponsor details | Manor House
John Radcliffe Hospital
Headley Way
Oxford
United Kingdom
OX39DU |
| Sponsor telephone | +44 (0)1865 222143 |
| Sponsor email | valerie.berry@orh.nhs.uk |
| Sponsor website | http://www.oxfordradcliffe.nhs.uk/home.aspx |
| Contact name | Dr Jennie Rechner |
| Contact details | Kadoorie Centre, Level 3
John Radcliffe Hospital
Headley Way
Oxford
United Kingdom
OX3 9DU |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN38888037 |
| Date last extracted from ISRCTN register | 17/04/2008 |
