The Tulip GT airway versus Guedel with facemask airway
| ISRCTN | ISRCTN11759551 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11759551 |
| Secondary identifying numbers | N/A |
- 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
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
Public
6 Robin Grove
London
N6 6NY
United Kingdom
| Phone | +44 (0)7770224064 |
|---|---|
| pnrfmt@msn.com |
Study information
| Study design | Single-centre randomised cross over study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Hospital |
| Study type | Other |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | 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. |
| Secondary outcome measures | Ease of use and airway preference by the inexperienced user is assessed. |
| Overall study start date | 01/04/2013 |
| Completion date | 01/07/2015 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | Both |
| Target number of participants | 60 users + 60 patients |
| 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
- England
- United Kingdom
Study participating centre
Middlesex
Harrow
HA1 3UJ
United Kingdom
Sponsor information
Hospital/treatment centre
Watford Road
Harrow
Middlesex
London
HA1 3UJ
England
United Kingdom
| Phone | +44 (0)20 8864 3232 |
|---|---|
| neville.robinson@nhs.net | |
"ROR" |
https://ror.org/04cntmc13 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 01/05/2015 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The journal Anaesthesia (AAGBI) in 2015 |
| 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.
