USER GUIDE.

Transcription

1 USER GUIDE 1

2 Reusable Veterinary Supraglottic airway Management System for Rabbits and Cats 2

3 Contents Page No. 1. Introduction The v gel design Advantages of the v gel supraglottic airway device for use in anaesthesia Components and their function The v gel cuff Indications Contraindications Size selection Quick Start User Guide (brief instructions for use) Detailed User Guide Problem solving Warnings Further reading 40 3

4 1. Introduction 1.1 The v gel supraglottic airway device The v gel device is an innovative supraglottic airway device with a noninflatable, super soft, anatomically shaped cuff that creates an airway seal around the perilaryngeal framework and the upper oesophagus. It has been specifically researched, designed and developed for veterinary use to establish a highly effective airway during general anaesthesia and resuscitation. The v gel is a high performance alternative to endotracheal tube intubation. A good airway seal is created by the combination of a super soft gel like material, with a design that accurately mirrors the anatomy of the relevant species, without placing excessive pressure on upper airway structures. Its research and development has involved an extensive literature search; anatomical modelling; CAD designing, radiological imaging; an exhaustive neck dissection work on the relevant specie of animal; prototyping; and extensive clinical evaluations at both private veterinary practices and university hospitals across UK and Europe. 4

5 Rabbit v gel relative to the upper airway anatomy 1 Oesophageal seal Pharyngeal Seal Trachea v gel airway channel 5

6 Rabbit v gel relative to the anatomy 2 Oesophagu Airwa Epiglotti Stop point of insertion at entrance to oropharynx 6

7 Cat v gel relative to upper airway anatomy 1 Oesophageal Seal v gel Airway Channel Trachea Perilaryngeal Seal 7

8 Cat v gel relative to upper airway anatomy 2 Oesophagus Airway Epiglottis Stop point of insertion at entrance to 8

9 The v gel device has been specifically designed as a reusable device for veterinary anaesthesia and resuscitation and must be properly autoclaved following each patient use to reduce the risk of cross infection. The device is guaranteed for reuse of up to 40 times only. It has been developed via post mortem analysis and clinical trial work, both in general practice and at certain European veterinary teaching university centres of excellence. The v gel has been developed in a 3 stage process and matched closely to the highly regulated international standards required for human medical device development to ensure high quality performance and patient safety when in use. This approach was followed as there is an absence of regulation for the development of veterinary anaesthetic devices. The v gel device directs itself on insertion to glide into the perilaryngeal area and accurately positions over the larynx without the need for laryngoscopy. The head of the device snugly abuts the anatomical landscape of the larynx, and pharynx in a mirrored fashion, and significantly reduces the risk of laryngeal or tracheal trauma when compared with traditional methods and devices. The device is simple, safe and rapid to insert, as well as easy to clean and autoclave. The v gel has been designed without an encircling inflatable cuff to prevent device displacement following cuff inflation. Instead it uses a soft gel like material which promotes patient comfort and prevents excessive mucosal pressure. The tip of the device wedges into the upper oesophagus to reduce the risk of aspiration if regurgitation occurs. In some versions of the device (cat), a dorsal inflatable button provides an additional sealing effect if required, achieved by gently pressing the soft cuff against the dorsal perilaryngeal structures. 9

10 1.2 Advantages of the v gel supraglottic airway device for use in anaesthesia: First ever species specific anatomically designed airway devices. Using soft materials, they give a high quality pressure seal to avoid larynx and trachea trauma. This makes for safer anaesthetics, and superbly smooth and comfortable patient recoveries. Easy, safe, controlled and stress free insertions for patient, nurse and surgeon / anaesthetist. Low airway breathing resistance due to the larger breathing channel within the device. High quality pressure seal avoids leakage of volatile agents, so improving health and safety aspects of anaesthesia. Reducing volatile agent leakage into the nasopharynx will reduce patient sensitisation to the smell a common problem in lightly anaesthetised rabbits. Integral monitoring port to reduce dead space and making high quality monitoring easier. Integral bite block to stop patient damaging device and occluding the airway. Designed and validated for autoclaving and re use, eliminating the risk of patient cross infection and subsequent medical issues. 10

11 1.3 Components and their function The v gel device utilises combinations of soft medical grade silicones and shape designed to mould to the mouth and pharynx without causing trauma, while still being strong enough to maintain a patent airway. It has been produced to be easily autoclaved, and should be cleaned and autoclaved following each patient use to a maximum of 40 patient uses. 11

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16 1.4 The v gel cuff: The anatomically designed head of the device gently directs the epiglottis ventrally away from the airway channel and holds it out of the airway when the device is in position. All surfaces in contact with mucosa are made from ultra soft medical silicones that conform gently to the tissue layers. Oesophageal section: The distal tip of the v gel flexes dorsally on insertion, and glides into the upper oesophagus. This stabilises the device distally, and helps to prevent aspiration should regurgitation occur. It is possible to insert a lubricated oesophageal stethoscope separately over this section. Cat version contains a dorsal inflatable button max inflation 3ml. Inflation of this button gently pushes the device ventrally to improve the airway seal if necessary during positive pressure ventilation. 16

17 2. Indications The v gel device is indicated for: The establishment and maintenance of an airway during routine or emergency anaesthesia, for procedures in fasted patients, with spontaneous or Intermittent Positive Pressure Ventilation (IPPV). (The v gel device should only be used under the direct supervision of a Veterinary Surgeon.) The v gel device has been specifically designed for delivering high quality anaesthesia and should be used with electronic monitoring equipment (minimum standard Capnograph and Pulse Oximeter) as well the usual manual techniques. Relative Indications: The following alternative clinical applications need to be substantiated by clinical trials but available clinical data supports that the v gel airway device could prove useful and lifesaving during; Airway management when unexpected difficulties are encountered in placing an endotracheal tube. Airway management during emergency resuscitation 17

18 3. Contraindications The v gel is not recommended for use in the following situations: 1. The v gel device should not be used in procedures where excessive amounts of fluids are being used within the mouth (equipment cooling or flushing), or procedures where regurgitation/vomiting is likely or where full access to oral or pharyngeal structures is surgically required. 2. Abnormally limited mouth opening, pharyngeal or laryngeal masses, or other abnormalities with upper airway anatomy. 3. Appropriate validation is not yet available for patients with an ASA score of III and above. In ASA III IV, the device should only be used if other means of airway management have failed. Until suitable evidence is available, a risk benefit analysis should be made by the clinician in charge of the case as to whether to use the device or not for any patient. 18

19 4. Size selection: Size selection should be on the basis of the ideal weight for the patient size, rather than their actual weight if obese. The ideal size for each patient also depends on breed. The size chosen should be a snug but not tight fit within the oral cavity and pharynx. Gentle pressure only is required for insertion. If the device needs to be pushed hard then it is too large and should be changed for the next smaller size. Conversely if device is overly easily inserted and there is smell of anaesthetic gases then the device chosen is most likely too small and a larger size should be used instead. The following is intended only as a guide for correct sizing. With experience, it becomes simple to assess patient size, age and breed to determine the correct v gel size to use. Until this point, insertions should be done gently and a smaller size used immediately if insertions are difficult. Care should be taken to clinically assess individual anatomical variations as part of this guide. Rabbits: R1: Rabbits 0.6kg to 1.5kg. This size has been developed specifically for small breeds such as the Netherland Dwarf. It is also appropriate for use on small, immature rabbits, or rabbits with a small head in relation to their body. 19

20 R2: Rabbits 1kg to 2kg. This size is appropriate for use on small mature rabbits and can also be used in medium sized breeds with a shorter head length. R3: Rabbits 1.8kg to 3.5kg. This size is appropriate for medium breed mature rabbits. If the rabbit is this weight and obese, it is possible that the R2 will be more appropriate. R4: Rabbits of 2.5kg to 4kg. This size is appropriate for larger mature rabbits. R5: Rabbits of 3.5kg to 5kg. This size is appropriate for large breed rabbits such as French Lops. R6: Rabbits of 4.5kg upwards. This size is appropriate for giant breed rabbits such as Flemish Giants. D10001 D10002 D10003 D10004 D10005 D10006 R1 R2 R3 R4 R5 R6 XS S M L XL XXL 20

21 Cats: C1: Cats 1kg to 2kg. This size is appropriate for young cats, especially those with a shorter head. C2: Cats 1.5kg to 3kg. This size is appropriate for young or small cats. C3: Cats 3kg to 5kg. This size is suitable for normal size domestic cats. C4: Cats 3kg to 5kg. This size is suitable for normal size or larger domestic cats, but is suitable for a longer head length than with the C3. The v gel head has the same dimensions as the C3. C5: Cats 4kg to 6kg. This size is suitable for larger than normal adult cats such as entire male cats and some larger breeds. C6: Cats 5kg upwards. This size is suitable for very large breeds such as the Maine Coon. D10007 D10008 D10009 D10010 D10011 D10012 C1 C2 C3 C4 C5 C6 XS S M(S) M(L) L(S) L(L) 21

22 5. Quick start v gel Instructions for use (We recommend that you read the User guide in full and watch the videos on the website in before using this device) Preparation: 1. Ensure the patient is fasted and that the mouth inspected for and cleared of any foreign material 2. Ensure the patient is at a surgical plane of anaesthesia, without gag or upper airway reflexes. 3. Choose the correct v gel species and size (see Sizing Guide). Check the v gel is undamaged and has been autoclaved prior to use to prevent cross infection. 4. Always wear gloves to prevent contamination of the v gel. 5. Remove rubber cap of port on device connector and then securely connect a gas monitoring line to it. Connect the other side of the monitoring line to the patient monitoring equipment. 6. Lubricate thoroughly both dorsal and ventral surfaces of the cuff of the v gel device using a water based lubricant (VetLube). Care should be taken to ensure an excessive amount of lubricant does not occlude the airway channel and not to allow the lubricant to dry out before insertion. 22

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24 Insertion: 7. Apply an appropriate dose of a licensed topical local anaesthetic to the larynx. 8. The patient is best supported in sternal recumbence as for endotracheal intubation, with the head extended and mouth open. 9. Pull out the tongue (as for endotracheal intubation) and smoothly insert the lubricated v gel into the mouth, gently gliding the tip along the hard palate, with the dorsal placed indicators and monitoring port on device facing dorsally. End point of insertion will be when the shoulders of the device are gently abutting the pharyngeal arch, and a clear Capnograph trace is present straightaway or after ventilating the patient. 10. Normal insertion should take only a few seconds without any excessive force being used. 11. Tie the device using the V Tie material taking care not to displace the v gel, normally wrapping around the rings on body of device or on the open windows on the wings on the connector area. 12. The anaesthetic circuit tubing should be placed on the breathing circuit support device (d grip). This ensures that the weight of the breathing circuit does not displace the v gel from the correct position within the pharynx. The v gel should be allowed to lie in such a way as to match the angle of the maxilla. The breathing circuit should be placed to support it in this position. 24

25 13. If Capnograph traces are not apparent, and the patient is breathing, the device may have become dislodged from position. The v gel should be gently rotated, retracted slightly and re inserted. If Capnograph traces do not return the v gel should be removed and then reinserted. If it is impossible to establish a patent airway, a smaller device should be chosen as next option and failing that then an alternative method airway management should be sought. In Use: 14. If patient and breathing circuit position is changed during the operating procedure adjust the circuit holder (d grip) to the new position and check the vital signs remain normal on the monitoring equipment. Recovery: 15. The v gel design reduces the potential for upper airway trauma during airway management. Due to its use of soft materials and an anatomically matched design, gag and cough reflexes are rarely seen on recovery. The anaesthetist should be aware of this as recovery may be smoother and more rapid than is normal following traditional endotracheal intubation. 16. Remove the v gel just prior to anaesthetic recovery. 25

26 Cleaning and Life of device in use: Use of v gel device allows adherence to strict standards of sterility to prevent cross infection. The v gel has been designed to be sterilised between uses in a standard autoclave. 17. The v gel and holding cradle should be washed in an appropriate medical disinfectant, then rinsed thoroughly and dried; the device is to be replaced in the holding cradle and inserted into a autoclave bag; then autoclaved prior to next use. Mark off one indicator on the holding cradle prior to placing in autoclave bag to keep track of the number of autoclave cycles that the device has been used for. 18. Each v gel is validated for 40 autoclave cycles. This allows optimal performance of the soft materials. The v gel material will harden with excessive use which will degrade performance and increase patient risks. 19. After 40 patient uses replace the v gel device with a new one and dispose the old one according to the contractually agreed terms of purchase. 26

27 6. Detailed User Guide: (Further instructions are available for viewing on Pre insertion checks: 1. The device is supplied fully sterilised so does not require any additional sterilisation process before use. 2. In subsequent patient uses the v gel device should be clean and sterilised before use. The device has been designed for standard veterinary autoclave sterilisation processes. 3. Inspect the device for surface or airway damage and ensure it s in good condition for use. 4. Confirm that the airway is patent. 5. Check that the connector fits the anaesthetic circuit. 6. Check that the connector and bite block section is firmly attached to the soft material of the v gel. 7. If the v gel is damaged, do not use the device and replace it for another good condition unit. 8. Ensure the following items are in close proximity ready for clinical use: Water based lubricant (VetLube) Tying material (V Tie) Gas monitoring line Monitoring equipment Tube holder (d grip) 27

28 6.2 Pre insertion preparation (no more than 60 seconds before insertion): 1. Always wear gloves when handling the device to prevent cross contamination. 2. Apply a small bolus of water based lubricant (VetLube) onto the holding cradle. 3. Lightly lubricate first the back, then the sides and then front of the v gel cuff region. Ensure that no bolus of lubricant is present within the distal end of the airway channel. 4. Place the v gel device back within the holding cradle in the storage container to prevent contamination with any dust or hair. 5. Ensure that the lubricant is not allowed to dry out and lubricate again if it does dry out. 6. Ensure that monitoring equipment is securely attached to the gas monitoring port of the v gel via a gas monitoring line between the two items. 7. Always ensure the monitoring equipment is correctly functioning. 28

29 6.3 Induction of anaesthesia: 1. Pre oxygenate the patient prior to induction using a face mask. 2. It is absolutely essential to provide an adequate depth of anaesthesia prior to insertion of the v gel device (as it is for endotracheal intubation). Patients should not have any cough or gag reflex present, and should have a relaxed jaw tone, and no palpebral reflex. 3. Various premedication and induction regimes have been used with the v gel device. Intravenous induction (following premedication) using propofol has been found to allow easy insertion. 4. Apply an appropriate measured dose of a licensed topical local anaesthetic drug onto the larynx before insertion of device. 6.4 Recommended insertion technique: Normal insertion time is approximately 2 10 seconds. If excessive insertion force and time is required, it is likely that the device is too large, or that the anaesthetic depth is too shallow. No more than 3 unsuccessful insertions should be attempted in one patient. If any blood is noted on the v gel device during insertion or repositions, no further insertions should be attempted. 29

30 1. Check the patient s mouth to ensure that the airway is clear of any foreign material. 2. Patient should be placed in sternal recumbancy, as for normal endotracheal intubation. 3. Extend the tongue out of mouth. 4. The v gel must be used in the correct orientation to ensure that the airway channel is positioned over the larynx. Dorsal markers are on device. These markers must always face in a dorsal direction to ensure that the airway is patent in use. Ensure that the v gel airway opening is directed ventrally, and slide the v gel caudally over the tongue gliding against the hard palate. 5. Slight resistance will be felt as the device is directed through the pharyngeal arch, and then the device will be felt to flip ventrally into the pharynx until the head of the device sits dorsal to the larynx. 6. In rabbits, it can be useful to insert the device in a diagonal position, until it is past the molar arcades. The device can then be rotated into the correct orientation once the head is past the oropharynx. It is also useful to gently reposition the v gel by rotating it slightly and moving it slightly backwards or forwards if Capnograph traces are not immediately apparent. 30

31 7. The end point of insertion is determined by the presence of obvious capnography traces and the feel of the device contacting the pharyngeal arch. 8. The v gel must be correctly positioned while in use. If the v gel is accidentally mal positioned, it can reduce the airway seal or block the airway. Ensure that the Capnograph trace is always vigilantly monitored. 9. Place a tie on the v gel as close to the lips as possible, either on the ridged proximal section, or on the connector wings, and tie around the back of the head. In order not to disturb the position of the device, it is recommended to put the knot of the tie on the ventral surface of the device. 10. Capnography traces should be immediately noted once the device is fully inserted. Reposition the device if traces are not noted while chest movements are present. Small movements in a rostral or caudal direction accompanied by a small rotation and reposition are generally effective. Correct device positioning can be confirmed by capnography. If it is not possible to confirm a patent airway, then the v gel device should be removed and reinserted, or an alternative airway management technique used. 11. If chest movements are not present, it is possible to confirm correct device placement by gently artificially ventilating the patient and watching for chest movement and Capnograph trace. 31

32 6.5 Maintenance of anaesthesia: 1. Connect the device to an appropriate anaesthetic circuit. It is recommended that capnometry and pulse oximeter is used as a minimum monitoring standard. 2. The anaesthetic circuit must be supported by the circuit support device (d grip) to prevent the weight of the circuit displacing the v gel device. The angle of the v gel and circuit should match that of the maxilla of the patient. 3. Suboptimal ventilation can be improved by gentle changes in v gel orientation (angle in the pharynx) and position (gentle cranial or caudal movement). Changes should not be needed to be any more than 5mm. If this adjustment is necessary, the securing tie should then be re tied. 4. The v gel should be disconnected before any changes in patient position, and reconnected following the change in position. 32

33 6.6 Anaesthetic recovery: 1. The device should be removed at approximately the same time as an endotracheal tube would be. Swallowing reflexes are not as pronounced as they are for endotracheal intubation recoveries. Withdraw the v gel prior to full anaesthetic recovery. 2. To remove the v gel the tongue should be extended rostrally and the device should be gently slid out of the mouth. In rabbits, a gentle 20 rotation prior to withdrawal can be useful. 3. Oxygenation should be maintained using a face mask following withdrawal of the device, until the patient is conscious. 6.7 V gel cleaning and preparation for next use: 1. The v gel should be cleaned and flushed using a disinfectant solution. The device should be rinsed and dried well following cleaning, with care to avoid any residue being left within the airway channel. 2. The cleaned v gel should be replaced into the holding cradle in the storage box. The marker section on the cradle should be marked off to keep track of the cleaning cycles. The cradle should be placed in an autoclave pouch and autoclaved at a 120 C autoclave cycle. 33

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35 7. Problem solving: Inadequate ventilation or capnometry traces check for the following: 7.1 Inadequate depth of anaesthesia might lead to under insertion. It can also cause breath holding. In this case, the device should be withdrawn, and the depth of anaesthetic should be increased in an appropriate way, before re insertion is attempted. Breathholding is frequently seen during insufficiently deep rabbit anaesthetics. Insufficient depth of anaesthesia is the most common reason for poor ventilation or inadequate insertion. 7.2 The device has been inserted upside down. The dorsally printed face acts as an indicator and should be facing directly dorsally, with no angling of the device to one side or the other. If it is suspected that the device has been inserted upside down, the v gel should be completely removed, checked and then re inserted. 7.3 The device has been under inserted. On oral examination, the narrowing that should occur at the pharyngeal arch will be visible within the mouth. Provided there is no significant resistance, the device can be gently further inserted into the pharyngeal space. If there is significant resistance the device is too large and should be withdrawn, and a smaller device should be used. In smaller rabbits, it can be helpful to use a mouth gag to open the mouth prior to insertion. 35

36 7.4 The device has been over inserted. This allows the proximal oesophagus to block the airway channel. Small adjustments in a rostral direction should be attempted while checking the capnometry traces. It could also be that too small a device has been selected for use and a larger device be used instead. 7.5 Epiglottis down folding is known to occur with use of supraglottic airway devices. If this is suspected to have occurred and is obstructing the airway, the device should be removed and reinserted. Epiglottic downfolding tends to result in audible upper airway noise or partial/complete airway obstruction. It can be helpful to when reinserting the device to insert at a slight diagonal angle before gently rotating into the normal position at the end point of insertion. 7.6 The device is the wrong size. A device that is too large will not insert to the correct stop point, which may result in airway obstruction. A device that is too small may be under inserted, resulting in the same problem. 7.7 Lingual cyanosis has been found with the use of supraglottic airway devices due to pressure on the base of the tongue. A small caudal adjustment in device position should be attempted first. If this is unsuccessful, several options can be used: 1. The next size down of v gel device can be used. 2. The tongue can be fully extended out of the mouth. 36

37 3. The mouth can be intermittently opened, manually or by using a mouth gag, to intermittently relieve pressure on the base of the tongue. If the cyanosis is severe, and the above techniques are unsuccessful, the v gel device should be removed and an alternative should be used. 7.8 Air or anaesthetic agent leaks: The connector may not be properly connected to the anaesthetic circuit check and connect securely The device may be too small for the patient, resulting in inadequate filling of the pharyngeal space and perilaryngeal leak of gas and/or anaesthetic agent. The v gel should be removed and replaced with the appropriate size device The connector may have come loose from the soft v gel section. In this situation, the v gel should be removed and replaced with a new v gel The device may be malpositioned. Check that the v gel is not sitting diagonally on the perilaryngeal area and correct position if this is the case. Check the dorsal indicator to ensure that the device is not upside down Where a dorsal inflatable button is present, if all the above points are normal, the button can be inflated to increase the perilaryngeal seal. 37

38 7.9 Regurgitation: If regurgitation is suspected and the v gel does not have a gastric channel, the mouth should be suctioned immediately. Airway management should then be undertaken at the discresion of the clinician. If a gastric channel is present in the device, a lubricated suction tube should be passed and regurgitated material should be suctioned. Again, airway management should then be undertaken at the digression of the clinician. The v gel device is not recommended for use where regurgitation or vomiting is anticipated during the anaesthetic. For further advice contact Docsinnovent on or info@docsinnovnet.com. 38

39 8. Warnings: The User Instructions should be carefully read and followed at all times. Special attention should be paid to the following: 8.1 The v gel device should not be forcibly inserted in a patient who is too small. If the device is forcibly pushed in then anaesthesia should be maintained, and the base of the tongue should be gently depressed using a tongue depressor or laryngoscope. The tongue should be pulled gently forward at the same time, with a slight rotation of the device, and the device can then be withdrawn. 8.2 A surgical plane of anaesthesia should be induced prior to device insertion (a relaxed jaw tone and absence of swallow or gag reflexes). If insertion is attempted with insufficient levels of anaesthesia, various problems will be encountered, including coughing, gagging, attempted expulsion of the v gel, and the potential for under or over insertion, and laryngeal or mucosal trauma. 8.3 The v gel devices have not been validated for procedures lasting more than 4 hours. Until suitable evidence is available, a riskbenefit analysis should be made by the clinician in charge of the case as to whether to continue to use the device or not for any patient. 8.4 IPPV pressure should not exceed 30cm H To reduce the probability of cross infection the gas monitoring line should be disposed of after each patient use. 39

40 9. Adverse outcomes: The v gel has been designed in such a way as to mirror the anatomical framework of the upper airway. Due to this and the soft materials used in the design, it is unlikely that this design will cause trauma during correct use. A higher incidence of include sore throat, pharyngo laryngeal trauma, tongue numbness/cyanosis, nerve injuries, vocal cord paralysis, gastric insufflation or regurgitation and aspiration of gastric contents complications have been reported with both inflatable supraglottic devices or Endotracheal tubes. These complications may also occur during use in veterinary anaesthesia, and clinicians should be aware of them and take steps to monitor for adverse effects. The user guide instructions have been written to anticipate potential problems during clinical use. Providing that the device is inserted gently and if any serious problems are encountered, the device is removed and replaced with a standard endotracheal tube, the risks associated with this device appear to be minimal. It is the responsibility of the clinician in charge of the case to perform a risk assessment prior to and during the anaesthetic procedure. The v gel device should be used as part of a balanced anaesthetic protocol. 40

41 Further Readings; gel.com For Further information see and or contact us on or our Telephone numbers below. Follow us on Twitter and Facebook for further answers to your questions. Docsinnovent Ltd, 18 Hand Court, London, WC1V 6JF, UK. Tel: International +44 (0) ; (UK)