Teleflex LMA Supreme Instructions For Use

English
Instructions For Use – LMA Supreme™
1. DEVICE DESCRIPTION
The LMA Supreme™ is an innovative sterile single use supraglottic
airway management device.
The LMA Supreme™ provides access to and functional separation of
the respiratory and digestive tracts. The anatomically shaped airway
tube is elliptical in cross section and ends distally at the laryngeal mask.
The inflatable cuff is designed to conform to the contours of the
hypopharynx, with the bowl and the mask facing the laryngeal opening.
The LMA Supreme™ also contains a drain tube which emerges as a
separate port proximally and continues distally along the anterior
surface of the cuff bowl, passing through the distal end of the cuff to
communicate distally with the upper esophageal sphincter. The drain
tube may be used for the passage of a well lubricated gastric tube to
the stomach, offering easy access for evacuation of gastric contents.
The drain tube has an additional and important function – it may be
used as a monitor of correct positioning of the LMA Supreme™
following insertion and then for continuous monitoring of mask
displacement during use.
The LMA Supreme™ provides easy insertion without the need for
digital or introducer tool guidance and enough flexibility to permit the
device to remain in place if the patient's head is moved in any direction.
The two lateral grooves in the airway tube are designed to prevent the
airway tube kinking when flexed. A built-in bite-block reduces the
potential for tube damage and obstruction by patient biting.
The LMA Supreme™ has a new fixation system which prevents
proximal displacement. If correctly used, this enhance the seal of the
distal end around the upper esophageal sphincter thereby isolating the
respiratory tract from the digestive tract, so reducing the danger of
accidental aspiration.
Attached to the mask is a cuff inflation line terminating in a pilot
balloon and one-way check valve for mask inflation and deflation.
All components are not made with natural rubber latex.
The LMA Supreme™ is supplied sterile and for single use only. It is
terminally sterilized by Ethylene Oxide gas.
Figure 1: LMA Supreme™ components
LMA Supreme™ components (Figure 1):
(a) Anatomically-shaped airway tube
(b) A separate drain tube has been incorporated
(c) Inflatable cuff with interlocking proximal and distal segments
(d) Cuff inflation line
(e) Pilot balloon
(f) A rigid molded proximal component which forms separate airway
and drain tube ports
(g) Fixation tab
(h) Integral bite-block
2. INDICATION FOR USE
The LMA Supreme™ is indicated for use in achieving and maintaining
control of airway during routine and emergency anesthetic procedures
in fasted patients using either spontaneous or positive pressure
ventilation.
It is also indicated for use as the rescue airway device in CPR
procedures, in which the LMA ProSeal™, LMA Classic™ or the LMA
Unique™ have traditionally been used. The LMA Supreme™ is also
indicated as a "rescue airway device" in known or unexpected difficult
airway situations. The LMA Supreme™ may be used to establish an
immediate clear airway during resuscitation in the profoundly
unconscious patient with absent glossopharyngeal and laryngeal
reflexes who may need artificial ventilation.
It may also be used to secure an immediate airway when tracheal
intubation is precluded by lack of available expertise or equipment, or
when attempts at tracheal intubation have failed.
3. CONTRAINDICATIONS
Due to the potential risk of regurgitation and aspiration, do not use the
LMA Supreme™ as a "First Choice Airway" in the followings elective or
difficult airway patients on a non-emergency pathway:
- Patients who have not fasted, including patients whose fasting
cannot be confirmed.
- Patients who are morbidly obese, more than 14 weeks pregnant or
those with multiple or massive injury, acute abdominal or thoracic
injury, any condition associated with delayed gastric emptying, or
using opiate medication prior to fasting. However, in all these clinical
scenarios, the LMA Supreme™ is ideally suited to serve as an "airway
rescue device" in preference to the LMA Classic™ or the LMA
Unique™.
LMA Supreme™ is also contraindicated in:
- Patients with fixed decreased pulmonary compliance, such as
patients with pulmonary fibrosis, because the LMA Supreme™, may
not always provide an adequate seal around the larynx.
- Adult patients who are unable to understand instructions or cannot
adequately answer questions regarding their medical history.
- Patients who have had radiotherapy to the neck involving the
hypopharynx (risk of trauma, failure to seal effectively).
- Patients with inadequate mouth opening to permit insertion.
- Patients presenting for emergency surgery who are at risk of massive
reflux, such as acute intestinal obstruction or ileus, or patients having
been injured shortly after ingesting a substantial meal (but see above
under Indication for Use).
- Patients requiring head or neck surgery where the surgeon cannot
gain adequate access due to the presence of the device.
- Responsive patients with an intact gag reflex (CPR).
- Patients who have ingested caustic substances.
When used in the profoundly unresponsive patient in need of
resuscitation or in a difficult airway patient on an emergency pathway
(i.e. "cannot intubate, cannot ventilate"), the LMA Supreme™ should
be used preferentially to the LMA Unique™ as an airway "rescue"
device to ensure oxygenation. The risk of regurgitation and aspiration
is minimized as the LMA Supreme™ offers easy access to liquid gastric
contents, unlike the LMA Unique™. However, the ultimate choice of
the definitive airway "rescue" device remains with the airway manager.
The LMA Supreme™ should not be used in the resuscitation or
emergency situation in patients who are not profoundly unconscious
and who may resist LMA Supreme™ insertion.
4. WARNINGS
- In spite of encouraging case reports, it is not currently known
whether the LMA Supreme™ always affords protection from
aspiration even when correctly fixed in place.
- The presence of a gastric tube does not rule out the possibility of
aspiration if the device is not correctly located and fixed in place.
- The LMA Supreme™ may be ineffective for use in patients with
decreased pulmonary compliance due to fixed obstructive airways
disease because airway positive pressure requirement may exceed
seal pressure.
- Do not attempt to pass a gastric tube into the stomach via the drain
tube in the presence of known or suspected esophageal pathology.
- There is a theoretical risk of causing edema or hematoma if suction is
applied directly to the end of the drain tube.
- The benefits of establishing ventilation with the LMA Supreme™ must
be weighed against the potential risk of aspiration in some situations
including: symptomatic or untreated gastro esophageal reflux,
pregnancy over 14 weeks, multiple or massive injury, conditions
associated with delayed gastric emptying, such as the use of opiate
medication in patients with acute injury or peritoneal infectious or
inflammatory processes.
- The LMA Supreme™ is a single use device and it shall not be reused.
Reuse may cause cross infection and reduce product reliability and
functionality.
- Refer to MRI information prior to using LMA Supreme™ in MRI
environment.
- The LMA Supreme™ does not always reliably protect the patient from
effects of pulmonary aspiration of gastric contents.
- Should the LMA Supreme™ be used in a fasted patient who is at risk
of retained gastric contents, prophylactic measures to empty the
stomach contents and appropriate antacid therapy should be
employed by anticipation wherever possible.
- In patients with severe oropharyngeal trauma, the device should only
be used when other attempts to establish an airway have failed.
5. CAUTION
- Do not re-sterilize and/or reuse the LMA Supreme™. The device is
provided sterile and should be used straight from the package and is
not designed to withstand reuse, cleaning or exposure to disinfecting
or sterilizing agents.
- Do not immerse or soak the device in liquid prior to use.
- Only use with the recommended maneuvers described in the
Instructions For Use.
- Do not use the LMA Supreme™ if the device is damaged or the unit
packaging is damaged or opened.
- When applying lubricant avoid blockage of the airway aperture with
the lubricant.
- To avoid trauma, excessive force should not be used at any time
during insertion of the LMA Supreme™ or insertion of a gastric tube
through the drain tube.
- Never over-inflate the cuff after insertion. An appropriate intra-cuff
pressure is 60cm H O. This pressure should not be exceeded.
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Excessive intra-cuff pressure can result in malposition and pharyngo-
laryngeal morbidity, including sore throat, dysphagia and nerve
injury.
- If airway problems persist or ventilation is inadequate, the LMA
Supreme™ should be removed and an airway established by some
other means.
- Careful handling is essential. The LMA Supreme™ is made of medical-
grade PVC which can be torn or perforated. Avoid contact with sharp
or pointed objects at all times. Do not insert the device unless the
cuff is fully deflated as described in the instructions for insertion.
- Gloves should be worn during preparation and insertion to minimize
contamination of the airway.
- Store device in a dark cool environment, avoiding direct sunlight or
extremes of temperature.
- Used device shall be decontaminated first in accordance with local
hospital procedures for handling bio-hazard products and
subsequently disposed of by incineration or landfill in accordance
with all local and national regulations.
- Only use syringe with standard luer taper tip for inflation/ deflation
of the cuff.
This device contains Di(2-ethylhexyl)phthalate (DEHP) a substance
which has been associated with toxicity when use for long-term
procedures in transfusion equipment. However, this device is not
meant for long term use and so is unlikely to pose any toxicity risk.
There is no concern and/or known risk for use of this device on
children or nursing/pregnant women as the device is not meant for the
following exposure scenarios:
• Long term hemodialysis in adults (testicular, fertility, toxicity to
kidneys and developmental.
• Long term blood transfusion in children (testicular).
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• Transfusions in neonates (testicular and fertility).
• Extracorporeal oxygenation in children (testicular effects, fertility,
and toxicity to kidneys).
The risk and benefits of using this device shall be carefully evaluated by
clinician on a case by case basis.
6. ADVERSE EFFECTS
There is currently no data documenting adverse effects with the LMA
Supreme™. Until data becomes available, it should be assumed that a
similar incidence and range of adverse events might occur with the
LMA Supreme™ as occurs with the LMA ProSeal™.
- Both minor adverse effects (e.g. sore throats) and major adverse
effects (e.g. aspiration) following standard LMA™ (LMA Classic™)
airway use have been reported in literature.
- Review of published literature shows the incidence of aspiration with
the LMA™ airway is low (0.012%), with the main causes being
inappropriate patient selection and inadequate depth of anesthesia
- The LMA ProSeal™ is reported to offer some protection against the
aspiration of gastric contents and, as the design of the LMA
Supreme™ is generally similar to that of the LMA ProSeal™ but with
the additional of an enhanced esophageal sealing mechanism, it is
expected that the LMA Supreme™ will offer at least equal protection.
- The incidence of sore throat following LMA™ airway use is
approximately 13% and is usually mild and shortlived
- Infrequent neurovascular events reported with LMA™ airway use
include cases of hypoglossal nerve injury, tongue numbness
secondary to lingual nerve injury, tongue cyanosis, tongue
macroglossia, recurrent laryngeal nerve injury and vocal cord
paralysis. Although this has not proven for individual cases,
malposition and/ or excessive intracuff pressure are likely on
anatomical grounds to cause compression of nerves and/or blood
vessels. Cuff malposition is usually due to incorrect insertion
technique or inadequate depth of anesthesia, and excessive cuff
pressure due to over-inflation of the cuff following insertion,
inappropriate size selection or diffusion of nitrous oxide into silicone
cuffs. The effects of an incorrectly positioned and over inflated cuff
are most likely to be seen following prolonged surgery. The length of
surgery is not an issue in a correctly inserted and inflated LMA™
airway provided intra-cuff pressure is kept at the recommended level
of 60 cm H O.
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1
Brimacombe JR, Laryngeal Mask Anaesthesia. Principles and Practice,
Saunders 2004.
7. SIZE SELECTION
For normal adults, use the size 4 device as a first choice. After inserting,
fixing the device in place, and then inflating to the recommended
pressure, there should be a minimum of one cm gap between the
fixation tab and the patient's upper lip. If the tab is pressing on the lip
or very near to it, this indicates the device is too small for the patient
and the size 5 should be used instead to avoid the risk of (a) poor seal
against the esophagus and (b) possible pressure trauma to the lip. If
the fixation tab is more than 2.5 cm from the upper lip after fixation, it
may be advisable to use the size 3 device. The decision to change to a
smaller device will depend on the quality of the airway, device stability
and seal pressure achieved
Figure 2: LMA Supreme™ sizing
Figure 3: LMA Supreme™ sizing (method2)
The sizing method described above requires that all three adult sizes of
the LMA Supreme™ should be available to hand before inducing
anesthesia.
For adult patients who are either smaller or larger than normal, it is
often possible to obtain a good result using the size 4 device, provided
the quantity of air used to inflate the cuff is always based on achieving
60 cm H₂O intracuff pressure. In smaller patients this pressure is
achieved with a relatively small volume of air, while larger patients will
require larger volumes. However, when in doubt, an approximate
estimate of suitable sizing can be made by holding each device against
the side of the patient's face in the position corresponding to that
shown in figure 3.
8. PRE-USE PERFORMANCE TESTS
The following inspections and tests must be conducted before use of
the device. The performance tests should be conducted in an area and
in a manner consistent with accepted medical practice that minimize
contamination of the LMA Supreme™ before insertion.
Warning: Do not use the device should it fails any one of the
inspections or tests.
• Examine the surface of the LMA Supreme™ and drain tube for
damage, including cuts, tears, scratches or kinks.
• Examine the interior of the airway tube and drain tube to ensure
they are free from blockages kinking of the drain tube within the
airway tube or loose particles. Any particles present in the tubes
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