~Tulip GT Instructions for Use
Instructions for Use
Single Use Disposable
tulip gt
ageofaquarius
Tulip GT – Guedel Type
The Tulip GT is a latex-free, multi-sized adult oral airway consisting of a breathing tube within a polyhedral bevelled cuff fitted at the distal end which inflates behind the palatopharyngeal folds, below the soft palate, behind the tongue and fills the space within the oropharynx above and behind the epiglottis, above the level of the glottic entrance. The Tulip GT is designed to manage the airway during routine and emergency anaesthetic procedures and to establish a clear airway during resuscitation. The correct size Tulip GT is inserted so that the inflatable cuff enters the mouth first, with the concave aspect of the tube curve upper most when the patient is supine. The Tulip GT is then inserted according to size and colour markings upon the tube, relative to the size of the patient. The Tulip GT’s cuff is then inflated with a volume of air printed on the tube, according to pre-selected size, to form an airtight seal around the oropharynx. The Tulip GT can provide a clear and relatively secure ventilating airway without the need for the skill of laryngoscopy and tracheal intubation. When correctly performed, the insertion technique is straight forward, non-traumatic and is easily learned by non-anaesthetists. Full training in Tulip GT use is recommended for all.
1) Precautions;
i). Full inflation (as printed on the airway tube) after introduction is deemed necessary to achieve a stable, unobstructed, ventilating airway without any manipulations of the head, neck or jaw. Full inflation secures the Tulip GT, displaces anatomical structures maximally and forms the greatest ventilating seal.
ii). Ventilation pressures >20cmH2O increase the risk of gastric insufflation, dilation, regurgitation, reflux and their sequelae, so are not recommended when using a Tulip GT. The Tulip GT offers no protection against reflux, regurgitation or aspiration and is designed as an airway primarily for first-line ventilation.
iii). The Tulip GT is contraindicated in non-fasted patients and those at risk of aspiration, such as the grossly obese, those with hiatus hernia, previous opiate analgesia, those with a recent traumatic injury, massive or multiple injury, those of greater than 14 weeks gestation, those with an autonomic neuropathy and those with an acute abdomen, reduced gastric emptying or dilation of the stomach.
iv). If laryngeal spasm occurs, do not remove the Tulip GT, but treat the cause.
v). Be careful not to allow the weight of the breathing circuit to twist or displace the small-sized, light-weight Tulip GT when connected. Secure firmly. It is recommended that the breathing circuit is mounted “north”, pointing towards the patients head and the attending Anaesthetist. This reduces the amount of twist applied to the Tulip GT by reducing the rotational traction induced by a laterally mounted breathing circuit. Disconnect the Tulip GT from the breathing circuit during patient transfer to avoid displacement of the airway.
vi). It should be appreciated that the design of Tulip GT is based upon the principle of the air-tight oropharyngeal seal. This air, blood and secretion-tight seal allows the device to generate manual ventilating pressure and confidently protect the laryngeal inlet from descending blood and secretions with a blood and secretion-tight seal above the level of the cords, but below the impending surgery. Should there be an air-leak against ventilation, the Tulip GT seal cannot be considered as competent/protective against descending blood and secretions.
2) Product Information;
The Tulip GT is a multi-sized device. Sizing and colour-coding is similar to known oropharyngeal Guedel airways. The single use Tulip GT is supplied sterile in soft, sterile packaging, ready to use, and has a 3 year shelf life. The sterilization process used is EO gas sterilization. The standard single use Tulip’s are not MRI compatible. Specific Tulips (GT’s and Advance) are available with non-metallic valves for MRI use.
3) Pre-Use Checks;
Prior to each use, the pre-use checks must be carried out to establish if the Tulip GT is appropriate for use.
i). Examine the length of the Tulip GT, including the exterior and interior of the airway tube. Look through the breathing tube to ensure it is free from blockages, loose particles, cuts or indentations. If any of these are apparent, discard the Tulip GT.
ii). Deflate the cuff fully using a 60ml syringe. Re-inflate the Tulip GT with the recommended volume of air (printed on the airway tube) and check for any leaks or herniation. Discard the Tulip GT if either of these are apparent. Deflate the Tulip GT fully before use.
iii). Examine the airway connector. It should fit securely into the airway tube and using reasonable force it should not be possible to remove. If the connector is loose discard the Tulip GT to avoid the risk of accidental disconnection during use.
iv). It is an important design feature of the Tulip GT that the airway tube is transparent to permit instant detection of fluids in the tube. Discolouration of the tube prevents this and may also indicate a reduction in the strength of the tube. If the airway tube is discoloured discard the Tulip GT.
4) Insertion;
Anaesthesia must be deep enough to permit insertion.
i). Using a Tulip GT that is too small in size for the patient may cause leak on positive pressure ventilation when inflated or may result in poor ventilation due to sub-optimal displacement of anatomical structures in the oropharynx. If this happens, simply add air to the cuff to increase the cuff volume until you have sealed the leak, or move up one Tulip GT size. The Tulip GT will usually run cuff pressures of <50cmH2O at the recommended volumes so increasing cuff volume will increase intra-cuff pressures to approx. 60-80cmH2O. This is acceptable at induction of Anaesthesia but should be down regulated to approx. 50cmH20 when the patient is fully relaxed. Higher ventilation pressures are required at induction of Anaesthesia and so are higher cuff pressures to ensure a ventilating seal.
ii). Using a size that is too large for the patient may cause airway obstruction by folding down the epiglottis against the posterior wall of the oropharynx preventing ventilation. If this happens, move down one size.
iii). After pre-use checks prepare the Tulip GT for insertion by removing all the air in the cuff by pushing the cuff against the airway tube from above and below the curvature with a thumb, index and middle finger respectively, whilst deflating the cuff fully with a 60ml syringe. This creates the flat upper and lower surfaces necessary to insert the Tulip GT easily. Lubricate the top and bottom of the cuff thoroughly just before insertion. Do not lubricate the front as this may result in aspiration of lubricant.
iv). Position the head and neck as for normal intubations. Preferably use one pillow, keep the neck flexed and the head extended by pushing down on the occiput with one hand, and tipping up the chin with the other. Allow the mouth to fall open, rather than opening the mouth by pulling down the mandible. Move the lower lip and insert the Tulip GT lightly into the open mouth from the direction of the lower jaw. When inserting the Tulip, hold it like a pen with the thumb, index and middle fingers at or below the connector. Insert the Tulip GT into the mouth after moving the lower lip out of the way and slide the Tulip GT tip against and along the hard palate so the Tulip GT’s tip is kept posterior within the oropharynx on introduction. Rotate the holding hand so that the Tulip GT slides into the mouth and round the corner into the oropharynx behind the tongue. This rotation allows the Tulip GT’s tip to slide round, behind the tongue, rather than impact the back of the throat tip-first or slide into the vallecula, both of which will prevent further insertion. If any resistance to introduction is felt, this will usually be because the tip of the Tulip GT is impacting on the back of the throat, or because the Tulip’s tip is within the vallecula above the epiglottis if the size of Tulip GT is too large. This usually does not happen if the recommended technique of sliding the Tulip GT along the hard and soft palates is followed, as the curvature of the hard and soft palates steers the Tulip GT’s tip “south” into the oropharynx. Resistance to introduction may be the Tulip tip impacting the back of the throat. In this case, it is required that the Tulip tip be retracted and steered “south” into the oropharynx.
v). Check that the centre mark printing on the convex surface of the breathing tube faces the upper lip and is centrally placed before inflating the cuff, as this will permit the Tulip GT to position itself correctly when inflating and must be completed prior to securing the Tulip GT or connection to the gas supply. Inflate the cuff with sufficient air to obtain a low-pressure ventilating seal using a 60ml syringe. The maximum inflation volume is marked on the individual sized Tulip GT’s breathing tube. Maintain +/- 40mmHg (54.38cmH2O) intra-cuff pressure. The volume of air may be increased to ensure a ventilating seal without a leak, or reduced to minimize cuff and mucosal pressures.
vi). Connect the Tulip GT to the gas supply, holding, securing then mounting the breathing tube to prevent displacement and gently inflate the lungs and confirm correct placement using a stethoscope and/or monitoring e.g. capnography. Secure the Tulip GT firmly in place, ensuring that the proximal connector end of the airway tube is pointing out of the mouth. Using the provided headband or tying the Tulip GT in place is recommended, but sticking may suffice. Proper securing and mounting of the small-sized, light-weight Tulip GT is mandatory. Be careful not to allow the weight of the breathing circuit to twist or displace the small-sized, light-weight Tulip GT when connected. It is recommended that the breathing circuit is mounted “north”, pointing towards the patients head and the attending Anaesthetist. This reduces the amount of traction applied by the breathing circuit and reduces the amount of twist applied to the Tulip GT by reducing the rotational traction induced by a laterally mounted breathing circuit. It must be remembered that the breathing circuit out-weighs the Tulip GT and as such may pull the Tulip GT out of the patient’s mouth if the Tulip GT is not tied or secured properly. The rotational traction of a laterally mounted breathing circuit may induce significant twist upon the small-sized, light-weight Tulip GT. This twisting of the Tulip GT must be monitored using the printed centre markings on the convex surface of the breathing tube that faces the Anaesthetist.
vii). The multi-size Tulip GT may be inserted according to patient size and the recommended inflation volume used to begin with. The volume may then be increased or decreased, as required, to achieve both a positive pressure ventilating seal without a leak and an acceptably low cuff pressure (+/-40mmHg/54.4cmH2O). The volumes below are only to be used as guidance. Any leak may then be sealed by the addition of air into the cuff until the leak stops. It is likely that adequate ventilation (<20cmH2O) will still be possible despite any small leak in most patients. Once airway control has been achieved the cuff pressure should be measured and reduced towards the ideal target of approximately +/- 40mmHg (54.38cmH2O) by the removal of air from the cuff down to the minimum level where by there is no ventilating leak. Equally, the cuff pressure may be raised to increase the ventilating pressure available in emergencies, as required5).
| Patient size (adult) | Small | Medium | Large | Extra Large | |
|---|---|---|---|---|---|
| Patient size/sex | Large Child/ Small Female |
Large Female/ Small Male |
Large Male |
Extra Large |
Maximum inflation |
| Patient approx. weight | 40-60kg | 60-80kg | 80-100kg | >100kg | |
| Initial inflation volume and inflation pressure |
+/- 40mls 54.38cmH20 |
+/- 50mls 54.38cmH20 |
+/- 60mls 54.38cmH20 |
> 60mls 54.38cmH20 |
80mls max. 54.38cmH20 |
| Oropharyngeal airway colour and size | Green Size 2 |
Orange Size 3 |
Red Size 4 |
White Size 5 |
Monitor cuff pressure |
5. Maintaining the Airway;
Obstruction can occur if the light-weight Tulip GT becomes dislodged or is incorrectly inserted. Secure firmly upon introduction and mount breathing circuit with caution.
Obstruction can occur if the light-weight Tulip GT becomes twisted. Secure firmly upon introduction and mount breathing circuit with caution.
Obstruction can occur if the epiglottis is pushed down with an excessive depth of insertion, poor insertion technique or if the Tulip GT is inserted/re-inserted when it is inflated. Check by auscultation of the neck and correct by withdrawing the device slightly. If this is unsuccessful removal, deflation and re-insertion will be required, or elevation of the epiglottis using a laryngoscope.
Malposition/folding of the epiglottis over the front of the Tulip GT breathing tube may present a “flap-valve”, intermittent obstruction that allows inspiration but not expiration. This may happen if the Tulip GT is inserted/re-inserted when it is inflated. Deflate and re-introduce.
Over-insertion of the Tulip GT may present an intermittent obstruction that allows inspiration but not expiration. This is because the Tulip GT’s breathing tube is in contact with the laryngopharyngeal mucosa. Withdraw the Tulip GT until a ventilating airway with inspiration and expiration is achieved.
Malposition of the Tulip GT tip into the glottis may mimic bronchospasm.
Avoid moving the Tulip GT about in the oropharynx when the patient is in a light plane of anaesthesia, or if the Tulip GT is inflated. Re-inserting an inflated Tulip GT may cause epiglottic inversion/folding and consequent airway obstruction.
The Tulip GT may be introduced/re-introduced when partially-inflated (+/-40mls), but not when fully-inflated (>40mls).
Air may be withdrawn from the cuff during anaesthesia to maintain a low intra-cuff pressure (+/- 40mmHg/54.38cmH2O) and to compensate for gaseous diffusion into the cuff during anaesthesia. Intra-cuff pressure should ideally be maintained at or below mucosal capillary perfusion pressure (+/-40mmHg/54.38cmH2O). Higher Tulip GT intra-cuff pressures may be required to ventilate at pressures >20cmH2O without an audible leak. Simply add more air to the Tulip GT cuff until any audible leak disappears at the designated ventilation pressure, and re-monitor the intra-cuff pressure.
6) Removal;
i). The Tulip GT is designed to allow the Patient to self-extubate with a fully-inflated cuff once unsecured. Before attempting to remove or deflate the Tulip GT it is essential to leave the patient completely undisturbed until the protective oro-laryngeal reflexes have fully returned. The Tulip GT airway should be left in place until the return of consciousness. The Tulip GT has low stimulus and may be tolerated by the fully awake patient upon recovery with eyes open. Do not remove the Tulip GT until the patient follows commands to pull out the Tulip GT themselves when fully awake.
ii). It is possible to remove the Tulip GT fully-inflated, partially-inflated or fully-deflated as required. Fully-inflated Tulip GT removal can be recommended in order to assist in airway management throughout recovery and the fully-inflated removal method provides the benefit of removing oral secretions from above the cuff as the Tulip GT is itself removed. If required deflate the Tulip GT cuff partially/completely just prior to removal.
iii). Look for the onset of swallowing which indicates oro-laryngeal reflexes are almost restored. It is usually necessary to perform some suction above the Tulip GT’s cuff but the correctly used Tulip GT should protect the larynx from upper airway secretions. Suction equipment should be available at all times.
iv). Following removal the single-use Tulip GT must be safely and appropriately discarded as contaminated medical waste.
Dr. Amer Shaikh World-Wide Patents Granted
Revised 09.12.13. Age of Aquarius, UK.