The Tulip GT airway versus Guedel with facemask airway

ISRCTN	ISRCTN11759551
DOI	https://doi.org/10.1186/ISRCTN11759551
Protocol serial number	N/A
Sponsor	North West London Hospitals NHS Trust
Funder	North West London Hospitals NHS Trust

Submission date: 25/03/2015
Registration date: 13/04/2015
Last edited: 09/08/2017

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

Background and study aims
Airway management is poorly achieved by para-medic and inexperienced medical staff. The aim of this study is to find out whether users perform better with a new device (Tulip GT airway) or a conventional mask (Guedel with facemask airway)? This new device may have a place in out-of-hospital and in-hospital resuscitation.

Who can participate?
Inexperienced users annually trained with Basic Life Support skills (BLS).
Adults patients undergoing scheduled surgery.

What does the study involve?
A group of 60 inexperienced users who are trained in BLS skills are introduced to a new airway device that has already been tested on manikins and in other studies. All patients undergoing surgery will be allocated to one device and then to the other.

What are the possible benefits and risks of participating?
The potential benefits of the new device are ease of use, secure, hands free, has a steep learning curve and cost. Neither device protects the airway from aspiration of stomach contents but all patients are undergoing elective surgery and anyone with this risk is excluded from the study.

Where is the study run from?
North West London Hospitals NHS Trust (UK)

When is the study starting and how long is it expected to run for?
From April 2013 to July 2017.

Who is funding the study?
North West London Hospitals NHS Trust (UK)

Who is the main contact?
Dr Peter Neville

Contact information

Dr Peter Neville Robinson
Public

6 Robin Grove
London
N6 6NY
United Kingdom

Phone	+44 (0)7770224064
Email	pnrfmt@msn.com

Study information

Primary study design	Interventional
Study design	Single-centre randomised cross over study
Secondary study design	Randomised cross over trial
Scientific title	The Tulip GT airway versus Guedel with facemask airway: a randomised crossover clinical study using inexperienced users in anaesthetised patients
Study objectives	Is the Tulip airway easier to use and does it provide better ventilation for unconscious patients when compared to the Guedel with facemask ventilation when used by inexperienced users? 60 inexperienced users (with Basic Life Support BLS skills) will manage the airway on 60 anaesthetised patients
Ethics approval(s)	NRES Committee London, 11/11/2011, 11/LO/1400
Health condition(s) or problem(s) studied	Airway management in the community and by para-medical staff is widely accepted as poor. Good airway management is fundamental to a safe outcome.
Intervention	Two different airway devices are being tested. The most common in use is the facemask. A new device (Tulip airway) works better in manikins. Ventilation parameters are measured using both devices in unconscious (anaesthetised) consented patients. The subjects are inexperienced users with BLS skills.
Intervention type	Device
Phase
Drug / device / biological / vaccine name(s)
Primary outcome measure(s)	Parameters measured are tidal volume, peak inspiratory pressure, end-tidal carbon dioxide. Three breaths are recorded. After anaesthesia is induced in the patient, the depth of anaesthesia is deepened until the patient has total jaw relaxation. The consultant anaesthetist doing the study confirms that the airway is manageable and that the patient can be ventilated and ventilates the patient 3 times and measures the ventilatory parameters of tidal volume, airway pressure and end tidal carbon dioxide. The inexperienced user then ventilates the patient using both devices in a randomised order. The first 3 breaths that are achieved with each device are measured using the same end-points as the consultant. The inexperienced user is given 60 seconds to achieve ventilation. The study is abandoned if there is patient compromise. The exact time points are 3 breaths within 60 seconds oaf attempting ventilation.
Key secondary outcome measure(s)	Ease of use and airway preference by the inexperienced user is assessed.
Completion date	01/07/2015

Eligibility

Participant type(s)	Mixed
Age group	Adult
Lower age limit	18 Years
Upper age limit	70 Years
Sex	All
Target sample size at registration	120
Key inclusion criteria	All users must have had BLS training within the last year. All patients must be 18-70 years old, ASA 1 or 2, scheduled surgery with no risk factors for regurgitation.
Key exclusion criteria	1. Risk of regurgitation 2. Vomiting 3. ASA status greater than 2
Date of first enrolment	01/04/2014
Date of final enrolment	01/04/2015

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Northwick Park Hospital

Watford Road
Middlesex
Harrow
HA1 3UJ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2016		Yes	No

Editorial Notes

09/08/2017: Publication reference added.