Secondary intubation through the ~Tulip GT

Secondary intubation through the Tulip GT® airway vs.
the Igel®; a randomized, controlled, cross-over manikin
study.

Dr. A Shaikh, Dr. N Robinson, Dr. D Vaughan, Dr. R Saini, Dr. M Cohen.
Northwick Park Hospital, Harrow, London, HA1 3UJ.

Introduction

The new Tulip GT® airway is a second generation oropharyngeal airway device which has been specifically designed to offer a hands-free, directly connectable alternative to the Guedel and Facemask and has shown to be an effective means of ventilation both in manikin and clinical studies with high success rates and statistically significant study results published in “Anesthesia”.

The management of the emergency difficult airway may be enhanced with the use of a Tulip GT® airway. It can be inserted by inexperienced BLS trained users and where limited mouth opening may be a consideration, as well as representing a possible adjunct to aid intubation in a compromised airway and as part of a failed intubation strategy, a role that the Tulip GT® was specifically designed for.

Current Difficult Airway Society (DAS) guidelines suggest a secondary tracheal intubation plan with the use of a fibreoptic scope should be considered and prepared for. Revised draft guidelines suggest insertion of a supraglottic device for failed tracheal intubation with subsequent consideration for intubation through the supraglottic device. The Tulip GT® airway may also be considered as a possible aid as part of a difficult
intubation strategy.

The study aimed to evaluate the ease of secondary fibreoptic intubation via both the Tulip GT® and an Igel® airway devices.

Protocol

Participants were asked to insert both a size 4 Tulip GT® and a size 4 Igel® into the mouth of a manikin in a randomized, controlled, cross-over method, first one device then the other. Ease of use and time to first breath were the main outcome variables in 29 events of insertion into the TRUCORP AIRSIM® manikin.

Participants were timed from the point of scope insertion into the supraglottic/oropharyngeal device to the point at which the first effective ventilation took place. The users speciality, grade, previous experience of fibreoptic intubation and ease of intubation on a 0 to 10 continuous line scale to were recorded (0 = difficult, 10 = easy). Participants were randomised to using Tulip or Igel® first to negate learning and user bias for device insertion.

A red colour-coded size 4 Tulip GT® was introduced into the manikins mouth until a natural resistance was felt and the outer connector lay flush with the manikin lips. The cuff was subsequently inflated with air to the volume as indicated on the Tulip GT® device (60 mls). Effective ventilation was determined by successful inflation of mannequin lung. Similarly a size 4 Igel® was inserted into the mannequin until a natural resistance was felt and successful ventilation judged in the same way.

A 6.0 mm internal diameter (ID) flexible-metallic endotracheal tube was pre-loaded on an Ambuscope®. Participants were allowed to ask for assistance in holding the scope or to have the endotracheal tube guided off the scope. Successful endotracheal intubation was confirmed by visualisation with an Ambuscope® and checking for successful manikin lung inflation after the Endotracheal tube cuff had been inflated and Tulip GT® cuff deflated. There is no cuff on the Igel.

Results User Grades; United Kingdom

0 = Difficult

10 = Easy

Time = Seconds (s)

Results User Grades; United Kingdom
ODP; Operating Department Practitioner
PA; Physicians Assistants; Non-Doctor Anaesthetic Specialists
FY1/2; Post Graduate Junior Doctors
CT1-5; Core Training Speciality Doctors
ST 1-7; Speciality Training Doctors
Consultants; Medical Trained Specialists
Speciality Grade Number of
previous
fibreoptic
intubations
Tulip – Ease TulipTime (s) Igel – Ease Igel Time (s)
Anaesthetics ST6 15 10 17 7.5 24
Anaesthetics Consultant 50 8.1 47 5.7 89
Anaesthetics Consultant <10 7.2 50 4.8 97
Anaesthetics ST3 4 6.4 65 5.4 37
Anaesthetics PA 10 8 47 7 47
Anaesthetics Consultant 30+ 8 26 8 240
Anaesthetics CT1 0 9 37 4 58
Anaesthetics PA Not known 6 20 5 20
Anaesthetics Consultant Many 10 27 7 71
Anaesthetics Consultant 4 7 39 7 43
Anaesthetics Consultant Not known 8.4 10 8.1 14
Anaesthetics FY1 0 9 7 4.7 59
Anaesthetics ST4 3 10 24 3 50
Anaesthetics CT2 0 9 37 6 80
Anaesthetics ST6 5-10 7.4 20 7.4 32
Anaesthetics Cons 10 7.9 10 5.3 20
Anaesthetics CT2 0 9 14 6 23
Anaesthetics CT1 0 8.6 40 7.6 90
Anaesthetics ODP 7 10 23 3.3 57
Anaesthetics Consultant >100 8.8 26 3.8 44
Anaesthetics ST6 1 9.8 35 6.7 52
Anaesthetics Consultant 25 9 30 7 62
Anaesthetics Consultant 100 8.5 42 4.7 79
Anaesthetics Consultant Not known 9 47 7 6
Anaesthetics Consultant Many 8.8 12 5.6 17
Anaesthetics Consultant >50 8 16 9 11
Anaesthetics Consultant Not known 10 35 5 65
Anaesthetics ST7 15 9 11 8 12
Anaesthetics Not known Not known 7.6 29 5.2 32
             
  Mean (average)   8.53 29.07 6.03 52.79
  SD   1.08 14.52 1.55 44.46

Discussion
The Tulip GT® airway represents an easy to use adjunct to secondary intubation when compared to the Igel.

This study demonstrated a difference in terms of;

The Tulip GT® airway appeared to have a quicker time to effective ventilation;

Tulip GT® = 29.07 seconds

Igel = 52.79 seconds

Tulip GT® demonstrated 44.9% faster use for intubation than Igel.

The Tulip GT® airway appeared to have a greater ease of insertion (10 = easy, 0 = hard);

Tulip GT® = 8.53/10

Igel = 6.03/10

Tulip GT® demonstrated 41.5% easier use for intubation than Igel.

The Tulip GT® demonstrated both faster and easier use for intubation than Igel. These combined features enables anaesthetic specialists to access airways for intubation in difficult airway scenarios whilst enabling more inexperienced users to maintain the airway for life support and first-line ventilation as outlined in previous human and manikin studies, as published ion “Anaesthesia”.

The advantage of the Tulip GT® airway as an adjunct for secondary tracheal intubation are that it may be used as a low stimulation alternative to the Guedel and Facemask airway for first-line airway management in Basic Life Support (BLS) to maintain oxygenation and ventilation, even by inexperienced users and non-medical staff.

Such intervention is frequently required in semiconscious patients but supraglottic airways such as the Igel and LMA cannot be used in semi-conscious patients due to the depth of their insertion and the higher level of stimulation such insertion causes, potentially inducting, coughing, gagging and vomiting, elevating risk of aspiration.

This low stimulation ability allows initial first-line users (Nurses, Ambulance, Police, Fire, Public etc.) to ventilate in an effective, hands-free, directly-connected fashion with high inspired O2 percentages and success rates and then allow speciality anaesthetic teams to insert Endotracheal tubes through the Tulip GT® device for secure intubation upon arrival, leaving the Tulip GT® in place. Importantly, the Tulip GT® airway allows secondary intubation without use of a guide, bougie or an airway exchange catheter.

The UK’s NAP4 report highlighted ineffective airway management and adverse clinical outcomes outside the Operating Theatre environment and recommended an improvement of airway management outside such environments, so to that end the Tulip GT® was specifically designed to offer such airway management improvements even in all environments, in all locations and by all users.

The combination of both favourable ease and speed of insertion in this manikin study appear to suggest that the Tulip GT® airway should be the device of preference for intubation through a first-line ventilation airway device.


International and World Wide Patents Granted | ~ Age of Aquarius | info@tulipairway.co.uk

International and World Wide Patents Granted -
Dr Amer Shaikh