Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Version 7
Study information
Scientific title
Acronym
PAWS
Study hypothesis
Does the laryngeal mask airway (LMA) have a superior efficacy in achieving manual ventilation (breathing) compared with the current recommended technique for children who are not breathing, when used by critical care and anaesthetic nurses?
Ethics approval
Approved by the Oxford Research Ethics Committee B on 17/08/2005, reference number: 05/Q1605/104
Study design
Randomised, controlled, efficacy study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Condition
Children undergoing ASA I or II surgery or an MRI scan
Intervention
Insertion of a LMA airway versus oropharyngeal airway. Patients have both airways inserted, however the order of the insertion is randomised, immediately prior to inserting the airway, the nurse opens a sealed opaque envelope generated using a table of random numbers which states which airway should be inserted first.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Chest excursion
Secondary outcome measures
1. Minute volume achieved by nurse and anaesthetist
2. Time to first breath
3. Mean inhaled and exhaled tidal volume
Overall trial start date
01/09/2005
Overall trial end date
01/09/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients aged between 6 months and 8 years scheduled for anaesthesiologists physical status (ASA) I and II surgery or a magnetic resonance imaging (MRI) scan
2. Patients who would routinely have an LMA inserted
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
70
Participant exclusion criteria
1. Patients with an expected difficult airway
2. Patients with oesophageal reflux
3. Patients under 6 months
4. Patients 9 years or older
Recruitment start date
01/09/2005
Recruitment end date
01/09/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Nuffield Department of Anaesthetics
Oxford
OX3 9DU
United Kingdom
Funders
Funder type
Charity
Funder name
The 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.