1. Introduction; concept and anatomy.

Written by admin on December 23, 2015. Posted in Instructions

1. Introduction; concept and anatomy.

1. Introduction; Concept and Anatomy

Full training in Tulip use is recommended.

Please refer to the anatomical illustrations.

The Tulip is a latex-free, one-size 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 is designed to manage the airway during routine and emergency anaesthetic procedures and to establish a clear airway during resuscitation or for ventilation. The Tulip 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 is then inserted to the depth as indicated by the scale marked upon the tube, relative to the size of the Patient. The Tulip’s cuff is then inflated with a volume of air which fits the Patient to form an air-tight seal around the oropharynx. The Tulip 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.

The Tulip is designed to be “one-size-fits-all-adults” and is designed to be “insert-to-fit” and “inflate-to-fit”.

The single-use Tulip 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 single use Tulip’s are MRI compatible.

Important points summary;

• The Tulip sits within the oro-pharynx and it stimulates the glossopharyngeal nerve, which causes swallowing in Patients upon recovery, rather than stimulating the superior laryngeal nerve in the laryngo-pharynx and causing gagging and vomiting, as per other similar devices.
• Full inflation (+/- 60mls) after introduction, whether inserted deflated or partially-inflated, is deemed necessary to achieve a stable, unobstructed, ventilating airway without any manipulations of the head, neck or jaw.
• The single-size adult Tulip may be inserted to the proper depth using the marked scale on the tube according to Patient size, and +/- 60mls inflation volume used in most adults 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 mucosal pressure. Any size adult or large child may be treated as any volume, large or small, may be used if these two parameters are met. The volumes below are only to be used as guidance, and the device sized individually to each Patient on an “inflate to fit” basis. Initially, +/- 60mls may be used safely to quickly gain airway control with ventilation in most adults. Any leak may then be sealed by the addition of air into the cuff until the leak stops. It is likely that adequate ventilation will be possible despite any initial 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 (54cmH2O) 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 required.
• Insert the Tulip into the mouth by sliding the tip against and along the hard palate. This allows the Tulip’s tip to be guided by the hard and soft palates into the oropharynx and pass behind the tip of the epiglottis.
• If any resistance to introduction is felt, this will usually be because the tip of the Tulip is within the vallecula above the epiglottis, or because the Tulip’s tip is impacting on the back of the oropharynx/mouth/throat. This may occur if the Tulip is not introduced along the hard and soft palates as is recommended. If the Tulip is slid along the back of the tongue on introduction, the Tulip’s tip may be guided directly into the vallecula. If this happens, remove and re-insert the Tulip as instructed in “7. Insertion”, or withdraw the Tulip a little and steer around the vallecula and under the epiglottis as required. Resistance to introduction may also be the Tulip tip impacting the back of the throat. This time it is required that the Tulip tip be steered “south”, into the oropharynx. This usually does not happen if the recommended technique of sliding the Tulip along the hard and soft palates is followed, as the curvature of the hard and soft palates steers the Tulip’s tip “south” into the oropharynx.
• Fitment is defined as no audible leak at normal ventilating pressures (+/-20cmH2O), but the Tulip is still likely to provide adequate Patient ventilation with adequate ventilation pressures despite any small leak. We may use a small audible leak as a method for limiting excessive or high ventilation pressures.
• The Tulip can be inflated to withstand ventilation pressures in excess of 100cmH2O in mannequins, so almost any ventilating pressures may be generated with the Tulip in-situ, depending upon the volume and pressure  within the Tulips balloon-cuff. Clearly, this value is considered excessive for Human ventilation and requires down regulation to the normal values of +/-20cmH2O using the pressure-regulating valve on the anaesthetic breathing circuit. Cuff pressures may thus also be reduced when such high levels of ventilation pressure are not required by the user.
  The Tulip may be inserted un-inflated or partially-inflated (+/-30mls), but not when fully-inflated (+/- 60mls) as this may cause epiglottic inversion, and may result in obstruction of the airway and on-going ventilation.
• Partial inflation of the Tulip cuff before insertion (+/-30mls) may assist inexperienced users insert the Tulip.
• For inexperienced users, the partially-inflated Tulip (+/-30mls) may be over-inserted until it meets a gentle resistance that stops further insertion, centralized, inflated to a full +/- 60mls with a 60ml syringe, then the breathing tube pulled back out until it meets gentle resistance to further withdrawal and a ventilating airway is achieved. Inexperienced users should use +/- 60mls (total) in everyone initially to achieve airway control and then reduce intra-cuff pressure to 40mmHg/54cmH2O.
• All users should allow the Tulip breathing tube to rise out of the mouth as the cuff is fully inflated. Do not push the Tulip back down into the mouth as this happens.
• For experienced users, insert the Tulip up to the depth required for the Patient, and as indicated by the markings of size, colour and scale on the breathing tube. The markings and colours correspond to Guedel “Small” Green (size 2, +/- 40mls), “Medium” Orange (size 3, +/- 50mls) and “Large” Red (size 4, +/- 60mls).
• Air may be withdrawn from the cuff during anaesthesia to maintain a low intra-cuff pressure (40mmHg/54cmH2O), and to compensate for gaseous diffusion into the cuff during anaesthesia. Intra-cuff pressure should ideally be maintained at 40mmHg (54cmH2O). Higher Tulip intra-cuff pressures may be required to ventilate at pressures >20cmH2O without an audible leak. Simply add more air to the Tulip cuff until any audible leak disappears at the designated ventilation pressure, and re-monitor the intra-cuff pressure.
• The user may choose between a low intra-cuff and mucosal pressure, or high ventilation pressures without a leak, as required. Normal ventilation pressures (+/-20cmH2O) are available with low intra-cuff pressures (+/-40mmHg/54cmH2O).
• Be careful not to allow the weight of the breathing circuit to twist or displace the light-weight Tulip when connected (see 7.14). Disconnect the Tulip from the breathing circuit during Patient transfer to avoid airway displacement.
• Proper securing and mounting of the small-sized, light-weight Tulip is mandatory. Be careful not to allow the weight of the breathing circuit to twist or displace the small-sized, light-weight Tulip 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 by reducing the rotational traction induced by a laterally mounted breathing circuit. It must be remembered that the breathing circuit out-weighs the Tulip by some margin, and as such may pull the Tulip out of the Patients mouth if the Tulip is not tied or secured properly. Disconnect the Tulip from the breathing circuit during Patient transfer to avoid airway displacement.
• Catheter and tube-mount connectors with a rotating “free-swivel” connection are recommended as minimal rotational traction is then applied by the breathing circuit and its connection to the light-weight Tulip.
• If mechanical obstruction occurs whilst a Tulip is in place, its position must be checked using the centre-line markings and printing on the Tulip breathing tube. Any deviation from the mid-line must be corrected. Check for under-insertion, over-insertion and rotational twisting.
• A sudden audible leak around the Tulip’s cuff may be the first indication the operating Anaesthetist gets of impending bronchoconstriction, and rising ventilation pressures. Normal ventilation pressures remain available to the Tulip’s user despite any audible leak. Maintain Patient ventilation until alternative airway arrangements are instituted.
• Reinforced versions of the Tulip are recommended for procedures to maintain safety of the airway when it cannot be seen, or when there is an excessive risk of tubal kinking or obstruction, such as the lateral and prone positions. Ventilating pressures must be minimized (<20cmH2O) to prevent gastric insufflation and dilation. Reflux and regurgitation must be monitored in such Patient positions.
• It should be appreciated that the design of Tulip 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. This then enables the Tulip to be used instead of Endotracheal intubation and throat packs, as the glottic protection is afforded by the large balloon-cuff that generates an air, blood and secretion-tight seal above the level of the laryngeal inlet, keeping it safe from descending blood and secretions from the surgery that is occurring above the Tulip’s air-tight cuff.
• Should there be a leak against ventilation, the Tulip seal cannot be considered as competent against descending blood and secretions.
• If the Tulip leaks audibly, Patient ventilation will still be possible despite any such leak. The Tulip will only leak at peak-pressures, and ventilation below that peak pressure will still be possible.
• Tulip intra-cuff pressures should be monitored at all times and reduced to 40mmHg (54cmH2O) whenever possible, as excessive intra-cuff pressures may compromise blood flow to the Tongue, so must be monitored.
• The Tulip is NOT recommended for use in Patients with an increased risk of aspiration.
• Ventilation pressures >20cmH2O increase the risk of gastric insufflation, dilation, regurgitation, reflux and their sequelae, so are not recommended when using a Tulip. The Tulip offers no protection against reflux, regurgitation or aspiration.
• Grossly obese Patients are more likely to regurgitate. These Patients are considered unsuitable candidates for a Tulip.
• The Tulip in no way prevents aspiration of regurgitated gastric contents. It is important to be vigilant.
  The Tulip 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.
• The Tulip may be effectively used to quite high ventilatory pressures, and these pressures may be relied upon in times of emergency ventilation, but they require down-regulation using the pressure regulating valve upon the anaesthetic breathing circuit to prevent Patient harm.
• The Tulip is designed to be removed fully-inflated by the recovering Patient themselves, after it has been unsecured to prevent any reflex gagging on a rigidly tied airway.

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