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
| ISRCTN | ISRCTN38042170 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN38042170 |
| Secondary identifying numbers | Version 7 |
- Submission date
- 14/03/2006
- Registration date
- 02/05/2006
- Last edited
- 07/12/2010
- 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 David Mason
Scientific
Scientific
Nuffield Department of Anaesthetics
John Radcliffe Hospital
Headley Way
Oxford
OX3 9DU
United Kingdom
Study information
| Study design | Randomised, controlled, efficacy study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Scientific title | |
| Study acronym | PAWS |
| Study objectives | 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(s) | Approved by the Oxford Research Ethics Committee B on 17/08/2005, reference number: 05/Q1605/104 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/09/2005 |
| Completion date | 01/09/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Months |
| Upper age limit | 8 Years |
| Sex | Both |
| Target number of participants | 70 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/09/2005 |
| Date of final enrolment | 01/09/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Nuffield Department of Anaesthetics
Oxford
OX3 9DU
United Kingdom
OX3 9DU
United Kingdom
Sponsor information
Oxford Radcliffe Hospitals NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Research and Development
Manor House
Headley Way
Oxford
OX3 9DZ
England
United Kingdom
"ROR" |
https://ror.org/03h2bh287 |
|---|
Funders
Funder type
Charity
The 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 |
