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~Tulip Advance, Instructions for Use

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Instructions for Use

Single Use
Single Adult Size

tulip advance

ageofaquarius

 

Tulip Advance

The Tulip Advance 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 Advance is designed to manage the airway during routine and emergency anaesthetic procedures and to establish a clear airway during resuscitation. The Tulip Advance 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 Advance is then inserted to the depth as indicated by the scale marked upon the tube, relative to the size of the patient. The Tulip Advance’s cuff is then inflated with a volume of air which fits the patient to form an airtight seal around the oropharynx. The Tulip Advance 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 Advance use is recommended for all.

 

1) Precautions;  

i). Full inflation (+/-60mls) after introduction, whether inserted fully-deflated or partially-inflated, is deemed necessary to achieve a stable, unobstructed, ventilating airway without any manipulations of the head, neck or jaw.
ii). Ventilation pressures >20cmH2O increase the risk of gastric insufflation, dilation, regurgitation, reflux and their sequelae, so are not recommended when using a Tulip Advance. The Tulip Advance offers no protection against reflux, regurgitation or aspiration.
iii). The Tulip Advance 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 Advance, 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 Advance when connected. Secure firmly. It is recommended that the breathing circuit is mounted “north”, pointing towards the patient’s head and the attending Anaesthetist. This reduces the amount of twist applied to the Tulip Advance by reducing the rotational traction induced by a laterally mounted breathing circuit. Disconnect the Tulip Advance from the breathing circuit during patient transfer to avoid displacement of the airway.
vi). It should be appreciated that the design of Tulip Advance 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 Advance’s seal cannot be considered as competent/protective against descending blood and secretions.

2) Product Information;        

The Tulip Advance 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 Advance 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 Advance’s are not MRI compatible. Dedicated MRI compatible Tulip Advance’s are available with non-metallic valves.

3) Pre-Use Checks;

Prior to each use, the pre-use checks must be carried out to establish if the Tulip Advance is appropriate for use.

i). Examine the length of the Tulip Advance, including the exterior and interior of the airway tube. Look through it to ensure it is free from blockages, loose particles, cuts or indentations. If any of these are apparent, discard the Tulip Advance gel viagra.
ii). Deflate the cuff fully using a 60ml syringe. Re-inflate the Tulip Advance with 80mls of air and check for any leaks or herniation. Discard the Tulip Advance if either of these are apparent. Deflate the Tulip Advance 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 Advance to avoid the risk of accidental disconnection during use.
iv). It is an important design feature of the Tulip Advance 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 Advance.

4) Insertion;

Anaesthesia must be deep enough to permit insertion.

i). After pre-use checks prepare the Tulip Advance 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 Advance 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.

Method 1: Colour-coded method; Measure using the TOP TEETH and insert the Tulip Advance up to the correct colour coding for small, medium or large and then inflate using a dedicated 60ml syringe. The stiff breathing tube may be used to lift the tongue on introduction.
SMALL: Insert to GREEN and add +/-40mls of air.        
MEDIUM; Insert to ORANGE and add +/-50mls of air.                                                                              
LARGE: Insert to RED and add +/-60mls of air.

Method 2: Over-insertion method; The stiff breathing tube may be used to lift the tongue on introduction. Insert up to and above the red colour indicator where possible, and then inflate to; Small @ +/-40mls, Medium @ +/- 50mls, Large @ +/- 60mls. Then pull back gently until one feels a firm but gentle resistance to further removal and ventilation is possible with expiration as well as inspiration. The cuff should not be in the mouth, rather visible in-situ at the back of the mouth.

Method 3: Partially-inflated method; The Tulip Advance may be inserted partially inflated (+/- 40mls in the cuff); The well-lubricated and partially-inflated Tulip Advance is introduced along the hard palate and steered into the oropharynx. The stiff breathing tube may be used to lift the tongue on introduction. As the Tulip Advance is introduced behind the tongue into the cavity between the base of the tongue and the epiglottis below (the vallecula) can be easily felt as the semi-inflated Tulip Advance “pops into position” within that cavity.

ii). 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 Advance lightly into the open mouth. When inserting the Tulip, hold it like a pen with the thumb, index and middle fingers just below the junction of the connector and tube. Insert the Tulip Advance into the mouth by sliding the tip against and along the hard palate so the Tulip Advance’s tip is kept posterior within the oropharynx on introduction. This allows the Tulip Advance’s tip to pass behind the epiglottis, 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 Advance is impacting on the back of the throat, or because the Tulip Advance’s tip is within the vallecula above the epiglottis. This usually does not happen if the recommended technique of sliding the Tulip Advance along the hard and soft palates is followed, as the curvature of the hard and soft palates steers the Tulip Advance’s tip “south” into the oropharynx. Resistance to introduction may be the Tulip Advance tip impacting the back of the throat. In this case, it is required that the Tulip Advance tip be retracted and steered “south” into the oropharynx. The stiff breathing tube may be used to lift the tongue on introduction.  If the Tulip Advance is slid along the back of the tongue on introduction, the Tulip Advance’s tip may be guided directly into the vallecula. If this happens, remove and re-insert the Tulip Advance as instructed, or withdraw the Tulip Advance a little and steer around the vallecula and under the epiglottis.
iii). Check that the central printed markings 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 Advance to position itself correctly when inflating and must be completed prior to 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 80mls. Maintain +/- 40mmHg (54.38cmH2O) intra-cuff pressure. +/-60mls is the initial fitment volume in adults and may be used as an initial volume to gain airway control. The volume of air may be increased to ensure a ventilating seal without a leak, or reduced to minimize cuff and mucosal pressures.

iv). Connect the Tulip Advance 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 Advance firmly in place, ensuring that the proximal connector end of the airway tube is pointing out of the mouth. Tying the Tulip Advance in place is recommended, but sticking may suffice. Proper securing and mounting of the small-sized, light-weight Tulip Advance is mandatory. Be careful not to allow the weight of the breathing circuit to twist or displace the small-sized, light-weight Tulip Advance 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 Advance by reducing the rotational traction induced by a laterally mounted breathing circuit. It must be remembered that the breathing circuit out-weighs the Tulip Advance and as such may pull the Tulip Advance out of the patient’s mouth if the Tulip Advance 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 Advance. This twisting of the Tulip Advance must be monitored using the printed centre markings on the convex surface of the breathing tube that faces the Anaesthetist.

v). The single-size adult Tulip Advance 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 (40mmHg/54.38cmH2O). 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 (<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 required.

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 Advance becomes dislodged or is incorrectly inserted. Secure firmly upon introduction and mount breathing circuit with caution.
  • Obstruction can occur if the light-weight Tulip Advance 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 Advance 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 Advance breathing tube may present a “flap-valve”, intermittent obstruction that allows inspiration but not expiration. This may happen if the Tulip Advance is inserted/re-inserted when it is inflated. Deflate and re-introduce.
  • Over-insertion of the Tulip Advance may present an intermittent obstruction that allows inspiration but not expiration. This is because the Tulip Advance’s breathing tube is in contact with the laryngopharyngeal mucosa. Withdraw the Tulip Advance until a ventilating airway with inspiration and expiration is achieved.
  • Malposition of the Tulip Advance tip into the glottis may mimic bronchospasm.
  • Avoid moving the Tulip Advance about in the oropharynx when the patient is in a light plane of anaesthesia, or if the Tulip Advance is inflated. Re-inserting an inflated Tulip Advance may cause epiglottic inversion/folding and consequent airway obstruction.
  • The Tulip Advance 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/54.4cmH2O) 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 Advance intra-cuff pressures may be required to ventilate at pressures >20cmH2O without an audible leak. Simply add more air to the Tulip Advance’s cuff until any audible leak disappears at the designated ventilation pressure, and re-monitor the intra-cuff pressure.

6) Removal;

i). The Tulip Advance is designed to allow the patient to self-extubate with a fully-inflated cuff once unsecured. Before attempting to remove or deflate the Tulip Advance it is essential to leave the patient completely undisturbed until the protective oro-laryngeal reflexes have fully returned. The Tulip Advance airway should be left in place until the return of consciousness. The Tulip Advance has low stimulus and may be tolerated by the fully awake patient upon recovery with eyes open. Do not remove the Tulip Advance until the patient follows commands to pull out the Tulip Advance themselves when fully awake.

ii). It is possible to remove the Tulip Advance fully-inflated, partially-inflated or fully-deflated as required. Fully-inflated Tulip Advance 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 Advance is itself removed. If required deflate the Tulip Advance 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 Advance’s cuff but the correctly used Tulip Advance should protect the larynx from upper airway secretions. Suction equipment should be available at all times.

iv). Following removal the single-use Tulip Advance must be safely and appropriately discarded as contaminated medical waste.

Dr. Amer Shaikh                                                                             World-Wide Patents Granted

Revised 16.09.13.                                                                                            Age of Aquarius, UK.