Condition category
Respiratory
Date applied
14/03/2006
Date assigned
02/05/2006
Last edited
07/12/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr David Mason

ORCID ID

Contact details

Nuffield Department of Anaesthetics
John Radcliffe Hospital
Headley Way
Oxford
OX3 9DU
United Kingdom

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 measures

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

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

Sponsor information

Organisation

Oxford Radcliffe Hospitals NHS Trust (UK)

Sponsor details

Research and Development
Manor House
Headley Way
Oxford
OX3 9DZ
United Kingdom

Sponsor type

Government

Website

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

Results - basic reporting

Publication summary

1. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17635426

Publication citations

  1. 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.

Additional files

Editorial Notes