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 |
| Secondary identifying numbers | Sponsor ref: 5339 |
- 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
Scientific
Kadoorie Centre, Level 3
John Radcliffe Hospital
Headley Way
Oxford
OX3 9DU
United Kingdom
Study information
| Study design | An interventional un-blinded, randomised single centre study. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 24/09/2007 |
| Completion date | 24/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Months |
| Upper age limit | 8 Years |
| Sex | Both |
| Target number of participants | 35 nurses, 105 children |
| 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
- England
- United Kingdom
Study participating centre
Kadoorie Centre, Level 3
Oxford
OX3 9DU
United Kingdom
OX3 9DU
United Kingdom
Sponsor information
Oxford Radcliffe Hospitals NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Manor House
John Radcliffe Hospital
Headley Way
Oxford
OX39DU
England
United Kingdom
| Phone | +44 (0)1865 222143 |
|---|---|
| valerie.berry@orh.nhs.uk | |
| Website | http://www.oxfordradcliffe.nhs.uk/home.aspx |
"ROR" |
https://ror.org/03h2bh287 |
Funders
Funder type
Charity
Resuscitation Council (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
