Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT03664700 |
| Other study ID # |
1338 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 5, 2019 |
| Est. completion date |
August 1, 2021 |
Study information
| Verified date |
October 2021 |
| Source |
Oxford University Hospitals NHS Trust |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The investigators want to investigate the user friendliness, and performance of the LMA
Protector. The principal research question is to assess the overall performance of the LMA
Protector. The investigators are merely making observations related to use of the device
during clinical practice.
Description:
There is a lack of research data on regarding the use of the LMA Protector. There is no
regulatory requirement to collect or publish patient data on any device, either before CE
marking or after. These devices are freely purchased and used.
There is, however, a professional duty to know that a device conforms to established norms
for use. These norms are not official standards but rather, reference data against which a
device can be clinically judged. Therefore, a device that is easy to insert but has a low
'leak pressure' (see above) is different from one that is more difficult to insert but as a
high leak pressure. It is not that one is 'better' than the other, but rather that the data
help create a 'usability profile' of the device which can be useful when making a clinical
selection for the device.
Preoperative assessment:
During the preoperative visit, patient information leaflet will be given to the patients
meeting the eligibility criteria.
Wherever possible, suitable patients will be identified in the preoperative assessment clinic
and the information leaflet given. The patients will be given adequate time to read this
information and any queries will be answered before being asked to sign a consent form. A
detailed airway assessment will be performed by one of the investigators and documented on
the study proforma.
Induction of anaesthesia:
On arrival in the anaesthetic room patients will be monitored with pulse oximetry,
electrocardiography and invasive or non-invasive blood pressure measurements. After
intravenous access is secured and the pre-surgical checklist completed, all patients will be
pre-oxygenated using a facemask to achieve end tidal oxygen concentration of at least 80%. A
'sniffing' position of the head and neck and a 20 degree head-up bed tilt will be used for
pre-oxygenation. General anaesthesia will be induced intravenously. After induction of
anaesthesia, facemask ventilation will be commenced and anaesthesia maintained with an
inhalational anaesthetic agent in oxygen or with total intravenous anaesthesia. The volatile
agent's (anesthetic gases) concentration of 1 MAC adjusted for the patient's age will be
achieved and maintained. This is normal process of anaesthesia applicable for all patients
irrespective of participation in the study.
Supraglottic airway device (SAD) insertion:
Once deep plane of anaesthesia is confirmed, with the absence of movement to jaw thrust
stimulation the SAD (LMA protector) will be inserted. The size of the device will be based on
the manufacturer's recommendations for the body weight. The breathing system will be
connected to the device. Ventilation of the lungs will be then confirmed by observing
adequate bilateral chest inflation and square end-tidal capnogram wave with positive pressure
ventilation. Adequate ventilation will be recorded if three tests are passed: 1) adequate
chest movement, 2) an expired tidal volume of at least 7 ml/kg and 3) stable oxygenation.
Time would continue until LMA® ProtectorTM inserted successfully. If it is not possible to
insert the device or ventilate through it, two more attempts at placement of the device will
be allowed. If placement has failed after two further attempts, the study will be abandoned
and the other device will be used. If this fails on first attempt a different LMA or tracheal
tube will be used as appropriate.
Maintenance of anaesthesia and recovery
The main interventions refer to the insertion of the airway device into the patient to obtain
a airway and allow the conduct of the anaesthetic and therefore the surgery. However, if
there are problems with the device and the airway obtained is suboptimal then the below
interventions are allowed (which will be noted in the data collection form):
1. Neck extension - move patient's neck upward
2. Neck flexion - move patient's neck downward
3. Chin lift - manoeuvre to open the airway
4. Jaw thrust - manoeuvre to open the airway
5. Reposition of the device At the end of operation, anaesthetic agents will be
discontinued while the device is left in place. The device will be removed after the
patient has regained consciousness, and has responded to verbal command to open the
mouth. Any complications that occur during the use of the device will be recorded.
Postoperative assessment Postoperatively in recovery or on the ward, the investigators will
visit each patient and determine whether the following airway complications are present after
surgery: sore throat (constant pain, independent of swallowing), dysphagia (difficulty in, or
pain provoked by, swallowing), sore jaw, dysphonia (difficulty in, or pain on, speaking),
numbness of the tongue or the oropharynx, ear pain, neck or mouth ache, hearing changes. Each
complication will be graded as none, mild, moderate or severe. The same questions will be
asked 24-48 hours later.
First visit During the first visit by the anaesthetist to the participant, at the
anaesthetist's earliest opportunity, either in the recovery area or on the ward, the
participants will be asked about the following complications, which will be graded as none,
mild, moderate or severe.
1. Vomiting
2. Lip or tongue swelling
3. Hearing changes
4. Ear pain
5. Sore throat
6. Pain on swallowing
7. Jaw pain
8. Neck or mouth ache
9. Pain on speaking
10. Numbness of the tongue
Second visit (or telephone consultation) During the second visit 24-48 hours post-operatively
on the ward or via telephone the participants will be asked about the following
complications, which will be graded as none, mild, moderate or severe.
1. Vomiting
2. Lip or tongue swelling
3. Hearing changes
4. Ear pain
5. Sore throat
6. Pain on swallowing
7. Jaw pain
8. Neck or mouth ache
9. Pain on speaking
10. Numbness of the tongue
