Condition category
Respiratory
Date applied
07/11/2007
Date assigned
03/04/2008
Last edited
28/03/2012
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 Jennie Rechner

ORCID ID

Contact details

Kadoorie Centre
Level 3
John Radcliffe Hospital
Headley Way
Oxford
OX3 9DU
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Sponsor ref: 5339

Study information

Scientific title

Acronym

PAWS 2

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.

Ethics approval

Ethics approval received from the Oxfordshire Research Ethics Committee A on the 10th Septermber 2007 (ref: 07/H0604/76).

Study design

An interventional un-blinded, randomised single centre study.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

24/09/2007

Overall trial end date

24/12/2008

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

35 nurses, 105 children

Participant 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

Recruitment start date

24/09/2007

Recruitment end date

24/12/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Kadoorie Centre, Level 3
Oxford
OX3 9DU
United Kingdom

Sponsor information

Organisation

Oxford Radcliffe Hospitals NHS Trust (UK)

Sponsor details

Manor House
John Radcliffe Hospital
Headley Way
Oxford
OX39DU
United Kingdom
+44 (0)1865 222143
valerie.berry@orh.nhs.uk

Sponsor type

Government

Website

http://www.oxfordradcliffe.nhs.uk/home.aspx

Funders

Funder type

Charity

Funder name

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