ADEPT 1 - Observational Study of the LMA Protector
Conditions: Airway Complication of Anesthesia
Sponsor: Oxford University Hospitals NHS Trust

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Study Title ADEPT 1 - Observational study of LMA Protector.  
Internal Reference Number / Short title: ADEPT 1 
Ethics Ref:  
IRAS ref: 234109 
Date and Version No: 06/08/2019 v4.0 
 
Chief Investigator: 
Dr Vassilis Athanassoglou, Consultant Anaesthetist, Nuffield 
Department of Anaesthetics, Oxford University Hospitals NHS 
Foundation Trust, E: Vassilis.athanassoglou@ouh.nhs.uk, T: 
01865 221591 
Investigators:  
Prof. 
Jaideep 
Pandit, 
Consultant 
Anaestetist, 
Nuffield 
Department of Anaesthetics, Oxford University Hospitals NHS 
Foundation Trust  
Prof Tim Cook, Consultant Anaesthetist, Royal United Hospitals 
Bath NHS Foundation Trust 
Prof Chris Frerk, Consultant Anaesthetist, Northampton General 
Hospital NHS Trust 
Dr Atul Kapila, Consultant Anaesthetist, Royal Berkshire NHS 
Foundation Trust 
Dr Iljaz Hodzovic, Consultant Anaesthetist, University Hospital 
of Wales  
Sponsor:  
Oxford University Hospitals NHS Foundation Trust  
Funder: 
Difficult Airway Society 
Chief 
Investigator 
Signature:  
 
 
None of the investigators have any conflicts of interest. 
 
 
Confidentiality Statement 
This document contains confidential information that must not be disclosed to anyone other 
than the Sponsor, the Investigator Team, HRA, host organisation, and members of the 
Research Ethics Committee, unless authorised to do so. 
 

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TABLE OF CONTENTS 
To update table of contents (TOC), hover cursor over the table and ‘right click’.  Choose 
‘update field’, then ‘update entire table’. 
 
1. 
SYNOPSIS .......................................................................................................................................................... 4 
2. 
ABBREVIATIONS ........................................................................................................................................... 5 
3. 
BACKGROUND AND RATIONALE ............................................................................................................ 5 
4. 
OBJECTIVES AND OUTCOME MEASURES ............................................................................................ 7 
5. 
STUDY DESIGN ............................................................................................................................................... 8 
6. 
PARTICIPANT IDENTIFICATION............................................................................................................. 9 
6.1. 
Study Participants ................................................................................................................. 9 
6.2. 
Inclusion Criteria ................................................................................................................... 9 
6.3. 
Exclusion Criteria .................................................................................................................. 9 
7. 
STUDY PROCEDURES .................................................................................................................................. 9 
7.1. 
Recruitment ............................................................................................................................ 9 
7.1. 
Screening and Eligibility Assessment ............................................................................. 10 
7.2. 
Informed Consent ................................................................................................................ 10 
7.3. 
Randomisation, blinding and code-breaking ................................................................ 10 
7.4. 
Baseline Assessments......................................................................................................... 10 
7.5. 
Subsequent Visits ................................................................................................................ 11 
7.6. 
Sample Handling...................................................................... Error! Bookmark not defined. 
7.7. 
Discontinuation/Withdrawal of Participants from Study.......................................... 12 
7.8. 
Definition of End of Study ................................................................................................. 12 
8. 
INTERVENTIONS (IF APPLICABLE) ..................................................................................................... 12 
9. 
SAFETY REPORTING (IF APPLICABLE) .............................................................................................. 13 
9.1. 
Definition of Serious Adverse Events ................................. Error! Bookmark not defined. 
9.2. 
Reporting Procedures for Serious Adverse Events ......... Error! Bookmark not defined. 
10. 
STATISTICS AND ANALYSIS ............................................................................................................... 16 
10.1. 
Description of Statistical Methods ................................................................................... 16 
10.2. 
The Number of Participants .............................................................................................. 16 
10.3. 
Analysis of Outcome Measures ........................................................................................ 16 
11. 
DATA MANAGEMENT ........................................................................................................................... 17 
11.1. 
Access to Data ...................................................................................................................... 17 
11.2. 
Data Recording and Record Keeping .............................................................................. 17 
12. 
QUALITY ASSURANCE PROCEDURES ............................................................................................. 18 
13. 
ETHICAL AND REGULATORY CONSIDERATIONS ...................................................................... 18 
13.1. 
Declaration of Helsinki ....................................................................................................... 18 
13.2. 
Guidelines for Good Clinical Practice .............................................................................. 18 
13.3. 
Approvals .............................................................................................................................. 18 
13.4. 
Reporting .............................................................................................................................. 18 
13.5. 
Participant Confidentiality ................................................................................................ 18 
13.6. 
Expenses and Benefits........................................................................................................ 19 
13.7. 
Other Ethical Considerations ............................................................................................ 19 
14. 
FINANCE AND INSURANCE ................................................................................................................ 19 
14.1. 
Funding .................................................................................................................................. 19 
14.2. 
Insurance............................................................................................................................... 19 
15. 
PUBLICATION POLICY .......................................................................................................................... 19 
16. 
REFERENCES ............................................................................................................................................ 21 

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17. 
APPENDIX A:  STUDY FLOW CHART ............................................................................................... 22 
18. 
APPENDIX B:  SCHEDULE OF STUDY PROCEDURES ..... Error! Bookmark not defined. 
19. 
APPENDIX C:  AMENDMENT HISTORY .......................................................................................... 24 
 
 
 

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1. SYNOPSIS 
 
A supraglottic airway device (SAD) is used in the airway management of patients undergoing 
general anaesthesia. It has two major components, a ‘mask’ which forms a seal over the glottis 
with or without the use of an inflatable cuff, and an ‘airway tube’ which transmits gases 
during ventilation from the mask to the anaesthetic breathing system. In the years since the 
introduction of the SADs numerous new devices have been developed. Initially these shared 
similar characteristics with the first devices and have been named ‘1st generation’ devices. 
The use of these devices carries a low but recognised risk of complications including 
aspiration of gastric contents, inadequate laryngeal seal, post-operative sore throat and 
difficulties with device insertion. In an attempt to address these issues manufacturers have 
developed ‘2nd generation’ SADs, which are designed to reduce the risk of aspiration and may 
claim features such as easier insertion, reduced trauma on insertion, superior seal pressures, 
and integral bite blocks. The LMA® ProtectorTM is a CE marked new single use SAD developed 
by Teleflex inc. It is a 2nd generation device which has a number of additional features 
compared to previous designs, incorporated to improve the safety of the device. We propose 
a national multi-centre prospective controlled clinical evaluation cohort study, to study the 
performance of the device and determine its likely place in clinical practice in the UK. 
 
Study Title 
Observational study of LMA Protector 
Internal ref. no. / 
short title 
ADEPT 1 
Study Design 
Prospective, multi-centre cohort study 
Study Participants 
Adult patients undergoing general anaesthesia with a SAD. 
Planned Sample Size 
1100 - 2000 
Planned Study Period 
2 years 
 
Objectives 
Outcome Measures 
Primary 
 
To assess overall performance of 
the LMA Protector 
1)First go insertion success 
rate, 
2)First 
go 
successful 
ventilation rate,   
3)Percentage of complication 
free insertions  
Secondary 
 
To assess:  
1) Time taken to achieve airway 
2) Number of attempts to achieve 
patent airway 
3) Complications during airway 
insertion 
4) 
Complications 
during 
anaesthesia attributed to the 
airway 
5) Complications during device 
removal 
6) 
Complications 
after 
anaesthesia attributed to the 
airway 
7) Quality of ventilation 
1) 
Time 
to 
first 
square 
capnography waveform 
2) Lowest oxygen saturation 
level 
3) 
Monitor 
numbers 
of 
interventions 
needed 
to 
ensure airway patency 
4) 
Monitor 
pre-defined 
complications 
occurrence 
during insertion of device, 
during anaesthesia, and on 
device removal 
5) The quality of ventilation 
will depend on whether there 
was: 
a) 
adequate 
chest 

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movement, b) tidal volume > 
7ml/kg, c) stable SpO2, and d) 
square capnography trace 
 
2. ABBREVIATIONS 
 
ASA 
American Society of Anesthesiologists 
ADE 
Adverse Device Effect 
CI 
Chief Investigator 
CRF 
Case Report Form 
GCP 
Good Clinical Practice 
HRA 
Health Research Authority 
ICF 
Informed Consent Form 
LMA 
Laryngeal Mark Airway 
NHS 
National Health Service 
NRES 
National Research Ethics Service 
PACU 
Post Anaesthesia Care Unit 
PI 
Principal Investigator 
PIL 
Participant/ Patient Information Leaflet 
R&D 
NHS Trust R&D Department 
REC 
Research Ethics Committee 
SADE 
Serious Adverse Device Effect 
SOP 
Standard Operating Procedure 
SAD 
Supraglottic Airway Device 
TSG 
Oxford University Hospitals NHS Foundation Trust/University of Oxford 
Trials Safety Group. 
TV 
Tidal Volume 
UADE 
Unanticipated Adverse Device Effect 
 
3. BACKGROUND AND RATIONALE 
 
Background 
A supraglottic airway device (SAD) is used in the airway management of patients undergoing 
general anaesthesia. It has two major components, a ‘mask’ which forms a seal over the glottis 
with or without the use of an inflatable cuff, and an ‘airway tube’ which transmits gases 
during ventilation from the mask to the anaesthetic breathing system (1). After the patient is 
anaesthetised, the device is advanced into the mouth over the tongue into the pharynx, 
resting in the hypopharynx and covering the supraglottic structures. This enables relative 
isolation of the trachea from other structures such as the oesophagus. Although the use of 

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SADs is primarily to enable ventilation during general anaesthesia where endotracheal 
intubation is deemed unnecessary or inappropriate, they also have an important role in the 
management of the difficult airway either as a rescue device or as a channel to intubate the 
trachea via fibre optic intubation (2). 
 
The original SAD, the laryngeal mask airway (LMA), was developed in the UK by Archie Brain 
and entered widespread use in 1989. Now named the LMA classic (cLMA) it was quickly 
adopted by the profession and revolutionised anaesthetic practice around the world. In 2010 
the Royal College of Anaesthetists (RCoA) carried out the 4th National Audit Project, which 
analysed major complications of airway management in the UK. At this time, a SAD was in 
use in more than 50% of all general anaesthetics, the majority using either the cLMA or 
similar design (3,4). 
 
In the years since the introduction of the cLMA numerous new SADs have been developed. 
Initially these shared similar characteristics with the cLMA and have been named ‘1st 
generation’ devices. The use of these devices carries a low but recognised risk of 
complications including aspiration of gastric contents, inadequate laryngeal seal, post-
operative sore throat and difficulties with device insertion (3). In an attempt to address these 
issues manufacturers have developed ‘2nd generation’ SADs, which are designed to reduce 
the risk of aspiration and may claim features such as easier insertion, reduced trauma on 
insertion, superior seal pressures, and integral bite blocks (5,6). These improvements have 
led to true advancement in the field (7-10) and have led to calls from experts for 2nd 
generation device use to become a standard of care (11). 
 
In 2011 the Difficult Airway Society (DAS), in response to concerns from the anaesthetic 
community that devices used in airway management were being introduced into clinical 
practice with minimal trial based evidence of their benefit, formed the ADEPT (Airway Device 
Evaluation Project Team) working group. The group made a number of recommendations on 
the evaluation of airway equipment prior to purchase, published in Anaesthesia in 2011 (12). 
These were subsequently adopted by DAS as guidance to its members involved in the 
procurement of airway equipment. The ADEPT guidance identifies that, although such 
devices may be sold under the Medical Devices Directive with little evidence of efficacy and 
safety, they should not be bought and used unless there is a minimum standard of evidence 
available proving such. The minimum acceptable level of evidence according to ADEPT 
guidance is 3b, i.e. a single case-control or historical case-control study, with more robust 
evidence preferred if feasible and practical. The guidance is clear that it does not consider 
RCT (1b) or systematic review (1a) to be necessary for airway device evaluation where more 
pragmatic and less resource intensive study designs may be adequate (12).  
 
Rationale 
The LMA® ProtectorTM is a new single use SAD developed by Teleflex inc. It is a 2nd generation 
device which has a number of additional features compared to previous designs, 
incorporated to improve the safety of the device (13). These features are: 
 
- 
Allows access to and functional separation of respiratory and digestive tracts 
- 
Two drainage channels enabling either direct suction at the upper oesophageal 
sphincter or the passage of a gastric tube 
- 
Integrated bite block 

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- 
A fixation system preventing proximal displacement 
- 
An elongated cuff enhancing the seal at the distal end of the mask at the upper 
oesophageal sphincter, designed to potentially reduce risk of aspiration 
- 
An integrated cuff pressure indicator enabling continuous monitoring of cuff pressure 
and optimisation (Cuff PilotTM Technology) 
- 
Enables passage of tracheal tubes up size 7.5mm internal diameter 
 
The device is an evolution on the design of previous 2nd generation SADs developed by 
Intavent Orthofix and now owned by Teleflex which are in everyday use around the world - 
LMA® ProSealTM, the LMA® SupremeTM, and the Guardian CPV TM airways, all with good 
evidence of safety and efficacy (7-10). 
 
The LMA® ProtectorTM is CE marked, produced in a number of sizes, and has been marketed 
for clinical use since mid-2016, without any design changes until now, and there is as yet only 
limited trial data on its use beyond pilot studies (14). Given the enhanced design of the LMA® 
ProtectorTM there are clear potential advantages to its use, and trial data is required to 
determine its safety and efficacy. In order to fulfil the ADEPT guidance minimum standard of 
evidence the device must be further evaluated before it may be safely recommended for 
purchase by hospital trusts in the UK. We propose a national multi-centre prospective 
controlled clinical evaluation cohort study, as sufficient to delineate the performance of the 
device and determine its likely place in clinical practice in the UK (or similar) rather than 
presupposing we will “recommend it”. The LMA® ProtectorTM is not used in standard care in 
any of the hospital trusts involved in the study. 
 
Study outline and research questions 
We will conduct a prospective multi-centre cohort study to evaluate the performance of the 
device. The main research questions pertain to the device performance, focusing on quality 
of the airway, ease of insertion, quality of ventilation, and incidence of complications.  
 
Participants 
All patients aged above 18, ASA grade 1 to 3, presenting for elective surgical procedures and 
requiring and suitable for a supraglottic airway device will be invited to take part in the study. 
Exclusion criteria are: a) patient refusal, b) below 18 years of age, c) requiring intubation, d) 
risk factors for aspiration, e) ASA 4 and above, f) mouth opening of less than 2.5cm and 
deemed to require awake intubation. 
 
Potiential risks 
The potential risks and burdens are the same compared to using other airway devices during 
anaesthesia. We will minimise them by ensuring adequate training in the use of the device is 
used, by recruiting investigators who are anaesthetists with experience of using similar 
airway devices more than 200 times. 
 
4. OBJECTIVES AND OUTCOME MEASURES 
 
Objectives 
Outcome Measures  
Timepoint(s) of 
evaluation 
of 
this 
outcome 

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measure 
(if 
applicable) 
Primary 
Objective 
To assess the performance of 
the LMA Protector 
1) First go insertion success rate,  
2) First go successful ventilation 
rate, 
3) Percentage of complication 
free insertions 
At 
time 
of 
anaesthesia 
Secondary 
Objectives 
To assess:  
 
1) Time taken to achieve 
airway 
2) Number of attempts to 
achieve patent airway 
3) Complications during airway 
insertion 
4) 
Complications 
during 
anaesthesia attributed to the 
airway 
5) Complications during device 
removal 
6) 
Complications 
after 
anaesthesia attributed to the 
airway 
7) Quality of ventilation 
1) Time to first square capnography 
waveform 
2) Lowest oxygen saturation level 
3) Monitor numbers of interventions 
needed to ensure airway patency 
4) 
Monitor 
pre-defined 
complications 
occurrence 
during 
insertion 
of 
device, 
during 
anaesthesia, and on device removal 
5) The quality of ventilation will 
depend on whether there was: a) 
adequate chest movement, b) tidal 
volume > 7ml/kg, c) stable SpO2, and 
d) square capnography trace 
At 
time 
of 
anaesthesia and 
post-operatively 
 
 
5. STUDY DESIGN 
 
This is a prospective, multi-centred cohort observational study, where all suitable 
participants will have the LMA Protector used.  The centres involved will be: Oxford 
University Hospitals NHS Foundation Trust, Northampton General Hospital, Royal Berkshire 
Hospital, Royal United Hospital, and University Hospital of Wales. The participants will be 
involved in the study for maximum 48 hours starting from approach for consent on the 
morning of surgery, while they are in the pre-operative area, until the second interview 
(either in person if participant is an inpatient, or via telephone if participant had been 
discharged). Data will be collected while the anaesthetic is being conducted apart from the 
information regarding the complications of the device removal and postoperatively. The 
order of events will be: a) consent, b) general anaesthetic as per standard care but using LMA 
protector, c) brief interview by clinician following operation in hospital at first available 
opportunity, d) another interview 24 to 48 hours later with the same questions either in 
hospital or at home by telephone. 
Data that will be collected will be: a) investigator name, b) number of previous insertions of 
the device by the investigator, c) patient age, d) patient gender, e) weight, f) height, g) ASA 
class, h) operation, i) anaesthetic drugs and dosages, j) anaesthetic technique, k) mode of 
ventilation, l) if further muscle relaxant used.  Moreover, we will collect:  
1) Airway assessment including Malampatti classification 
2) The number of attempts at the insertion will be recorded   

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3) Volume of air in cuff to achieve intracuff pressure of 60cmH2O 
4) Airway leak pressure 
5) The ease of insertion  
6) The lowest oxygen saturation recording 
7) The quality of ventilation  
8) The quality of the airway during maintenance 
9) The ease of hands free anaesthesia 
10) The overall usefulness of the device in the patient 
11) The overall performance of the device 
12) The time to first square capnography trace  
13) Positive or negative bubble test 
14) Airway manipulations to establish airway 
15) Complications on insertion, during use, and on removal of the device 
16) Post-operative oropharyngeal sequelae 
 
The data will be collected from the anaesthetic record. Data c, d, e, f will be collected from the 
electronic notes.  
All data will be recorded in the CRF/data collection form. 
 
6. PARTICIPANT IDENTIFICATION 
 
6.1. Study Participants 
Inclusion Criteria  
• Adult participants who are having a general anaesthetic.  
• Participant is willing and able to give informed consent for participation in the study. 
• Male or Female, aged 18 years or above. 
• ASA 1 – 3 category patients 
• Elective operations 
• Urgent operations 
• Patients suitable for an SAD based on patient and operation factors. 
 
6.2. Exclusion Criteria 
The participant may not enter the study if ANY of the following apply: 
• Refusal of consent 
• Age less than 18 years 
• Require intubation for the operation 
• Risk of regurgitation 
• ASA 4 and above 
• Mouth opening less than 2.5cm 
• Require awake intubation 
 
7. STUDY PROCEDURES 
 
7.1. Recruitment 
Potential participants will be identified on the morning of surgery during the preoperative 
anaesthetic visit. The investigator will be a member of the of the direct care team, i.e. the 
anaesthetist for the case. The investigator will examine whether the potential participant 
fulfils any of the inclusion criteria and none of the exclusion criteria apply to them. The 

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participant information leaflet will be given to the patient, the investigator will answer any 
questions the patient might have, and at least one hour will be given to the patient, which the 
study team feels this is an acceptable amount of time to ensure they have not been rushed 
into taking a decision. They will be asked to sign the consent form, of which the participant 
will keep a copy, another copy will be placed in the study file, and the original will be placed 
in the patient’s note.  
7.2. Screening and Eligibility Assessment 
On the morning of surgery, the investigator will examine their operating list and decide if the 
operations are suitable for the LMA Protector. The investigator will be a member of the of the 
direct care team, i.e. the anaesthetist for the case. 
If the patients do not meet any exclusion criteria then they will be asked whether they wanted 
to participate in the study, the PIL will be given to them and they will be given at least one 
hour to make up their mind. The investigator will then approach the patient again, answer 
any remaining questions and obtain informed consent.  
 
7.3. Informed Consent 
Informed consent will be taken by the anaesthetist investigator when they see the participant 
prior to the surgery. The participant must personally sign and date the latest approved 
version of the Informed Consent form before any study specific procedures are performed. 
Written and verbal versions of the Participant Information and Informed Consent will be 
presented to the participants detailing no less than: the exact nature of the study; what it will 
involve for the participant; the implications and constraints of the protocol and any risks 
involved in taking part. It will be clearly stated that the participant is free to withdraw from 
the study at any time for any reason without prejudice to future care, without affecting their 
legal rights, and with no obligation to give the reason for withdrawal. 
The participant will be allowed an hour to consider the information, and the opportunity to 
question the Investigator, or other independent parties to decide whether they will 
participate in the study. Written Informed Consent will then be obtained by means of 
participant dated signature and dated signature of the person who presented and obtained 
the Informed Consent. The person who obtained the consent must be suitably qualified and 
experienced, and have been authorised to do so by the Chief/Principal Investigator. A copy 
of the signed Informed Consent will be given to the participant. The original signed form will 
be retained at the study site. 
 
7.4. Randomisation, blinding and code-breaking 
Participants will not be randomised in this study. We are evaluating the performance of the 
LMA Protector airway device and thus if the participant signs the consent form the device 
will be used for their anaesthetic. 
 
7.5. Assessments during Anaesthesia 
The following measurements will be noted: 
1. Assessment of the airway including Malampatti classification 
2. The number of attempts at the insertion  
3. Volume of air in cuff to achieve intracuff pressure of 60cmH2O 
4. Airway leak pressure 
5. The ease of insertion  
6. The time to first square capnography trace  
7. Positive or negative bubble test 

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8. Lowest recorded oxygen saturation reading 
9. Airway manipulations to establish airway 
10. Complications during insertion 
11. Complications intraoperatively 
12. Complications during removal 
13. Complications postoperatively  
 
In addition to the above measurements the following aspects of the use of the device will be 
scored: 
1) The quality of ventilation  
2) The quality of the airway during maintenance 
3) The ease of hands free anaesthesia 
4) The overall usefulness of the device in the patient 
5) The overall performance of the device 
Lastly the investigators will note any complications during insertion, use and on removal of 
the device. Additionally, the participants will be asked about any post-operative 
oropharyngeal sequelae. 
 
7.6. Subsequent Visits 
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 

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7.7. Discontinuation/Withdrawal of Participants from Study 
Each participant has the right to withdraw from the study at any time.  In addition, the 
Investigator may discontinue a participant from the study at any time if the Investigator 
considers it necessary for any reason including: 
• Ineligibility (either arising during the study or retrospectively having been 
overlooked at screening) 
• Significant protocol deviation 
• Significant non-compliance with treatment regimen or study requirements 
• Withdrawal of Consent 
• Loss to follow up 
The reason for withdrawal will be recorded in the CRF. 
If the device cannot be inserted after 3 unsuccessful attempts to insert it, the study will be 
stopped, an alternative airway device will be used and the failure noted on the CRF. 
Participants who have been withdrawn will not be replaced. If a patient is withdrawn their 
research data will not be used in final analysis. 
 
7.8. Definition of End of Study 
The end of the study is following the final interview of the last patient (which could be on the 
ward or by telephone).   
 
8. INTERVENTIONS 
 
8.1. Interventions during anaesthesia 
Nothing listed below deviates from normal clinical practice for any similar SAD device, or for 
almost any type of anaesthetic: 
 
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. They 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. 

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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 
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, we 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. 
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 
 
8.2. Maintenanace and storage of the device 
The devices are single use. They will be stored in the anaesthetic store rooms in the operating 
theatre suites at the John Radcliffe, Churchill, West Wing, Women’s Centre, and Nuffield 
Orthopaedic theatres.  
 
9. SAFETY REPORTING  
 
9.1. Definitions 
9.1.1 Adverse Event (AE): 

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An AE or adverse event is: 
Any untoward medical occurrence in a patient or other clinical investigation participant 
taking part in a trial of a medical device, which does not necessarily have to have a causal 
relationship with the device under investigation.  
An AE can therefore be any unfavourable and unintended sign (including an abnormal 
laboratory finding), symptom or disease temporally associated with the use of the device, 
whether or not considered related to the device. 
9.1.2: Adverse Device Effect (ADE) 
All untoward and unintended responses to the medical device.  
The phrase "responses to a medical device" means that a causal relationship between the 
device under investigation and an AE is at least a reasonable possibility, i.e., the relationship 
cannot be ruled out. 
All cases judged by either the reporting medically qualified professional or the sponsor as 
having a reasonable suspected causal relationship to the device qualifies as a device effect.   
This also includes any event resulting from insufficiencies or inadequacies in the instruction 
for use or deployment of the device and includes any event that is a result of a user error.  
 
9.1.3 Serious Adverse Event (SAE):  
SAE is an adverse event that  
 Led to death  
 Led to fetal distress, fetal death or congenital abnormality or birth defect.  
 Led to serious deterioration in the health of the subject that  
o Resulted 
in 
a 
life-threatening 
illness 
or 
injury 
NOTE: The term "life-threatening" in the definition of "serious" refers to an 
event in which the participant was at risk of death at the time of the event; it 
does not refer to an event which hypothetically might have caused death if it 
were more severe. 
o Resulted in a permanent impairment of a body structure or a body function  
o Required in-patient hospitalisation or prolongation of existing hospitalisation  
o Resulted in medical or surgical intervention to prevent permanent impairment 
to a body structure or a body function  
o Other 
important 
medical 
events* 
*Other events that may not result in death, are not life threatening, or do not 
require hospitalisation, may be considered a serious adverse event when, based 
upon appropriate medical judgement, the event may jeopardise the patient and 
may require medical or surgical intervention to prevent one of the outcomes 
listed above 
To ensure no confusion or misunderstanding of the difference between the terms "serious" 
and "severe", which are not synonymous, the following note of clarification is provided: 
The term "severe" is often used to describe the intensity (severity) of a specific event (as in 
mild, moderate, or severe myocardial infarction); the event itself, however, may be of 
relatively minor medical significance (such as severe headache).  This is not the same as 
"serious," which is based on patient/event outcome or action criteria usually associated with 
events that pose a threat to a participant's life or functioning.  Seriousness (not severity) 
serves as a guide for defining regulatory reporting obligations. 
 
9.1.4 Serious Adverse Device Effects (SADE):  

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A serious adverse device effect (SADE) is any untoward medical occurrence seen in a patient 
that can be attributed wholly or partly to the device which resulted in any of the 
characteristics or led to a characteristics of a Serious adverse event.  
SADE is also any event that may have led to these consequences if suitable action had not 
been taken or intervention had not been made or if circumstances has been less opportune.  
All cases judged by either the reporting medically qualified professional or the sponsor.  
 
9.1.5 Unanticipated Adverse Device Effect (UADE):  
Any serious adverse device effect on health or safety or any life-threatening problem or death 
caused by, or associated with a device, if that effect, problem, or death was not previously 
identified in nature, severity or degree of incidence in the investigational plan or application 
(including a supplementary plan or application), or any other unanticipated serious problem 
associated with a device that related to the rights, safety or welfare of the subject. 
 
9.2. Reporting of AE 
All AE’s occurring during the study observed by the investigator or reported by the 
participant, whether or not attributed to the device under investigation will be recorded on 
the CRF as specified in the protocol.  All ADE’s will be recorded in the CRF.  
The following information will be recorded: description, date of onset and end date, severity, 
assessment of relatedness to device, other suspect drug or device and action taken.  Follow-
up information should be provided as necessary.  
The relationship of AEs to the device will be assessed by a medically qualified investigator or 
the sponsor/manufacturer and will be followed up until resolution or the event is considered 
stable.  
 All ADE that result in a participant’s withdrawal from the study or are present at the end of 
the study, should be followed up until a satisfactory resolution occurs. 
Where relevant, any pregnancy occurring during the clinical study and the outcome of the 
pregnancy, should be recorded and followed up for congenital abnormality or birth defect. 
 
9.3. Reporting Procedures for All SAEs/ SADEs/ UADEs 
All SAE/SADE/UADEs need to be reported to the sponsor/legal representative and 
manufacture and OUH R&D within one working day of the investigator team becoming 
aware of them.  
Reports of related and unexpected SAEs should be submitted to ethics within 15 days of the 
Chief Investigator becoming aware of the event, using the SAE report form for non-CTIMPs 
published on the NRES website. 
All reporting to ORH R&D should be by email to ouhsae.reports@ouh.nhs.uk  giving as much 
information about the incident as possible, and should be signed by the PI or Co-investigator. 
The ORH SADE reporting form should be used for ORH sponsored studies. 
 
The ORH R&D Department will undertake an initial review of the information and ensure it 
is reviewed by the ORH/University of Oxford Trial Safety Group Medical Monitor. Events will 
be followed up until resolution, any appropriate further information will be sent by the 
research team in a timely manner. 
Reporting to the MHRA will be done in liaison with the Chief Investigator and the 
Manufacturer.  

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The Manufacturer has a legal obligation to report all events that need to be reported to the 
Nominated Competent Authority immediately (without any unjustifiable delay) after a link is 
established between the event and the device, but no more than: 
 2 days following the awareness of the event for Serious Public Health Threat. 
 10 days following awareness of the event for Death or unanticipated serious 
deterioration in health. 
 30 days following the awareness of the event for all other event meeting the SAE 
criteria. 
9.4. Annual Reports 
In addition to the above reporting the Chief Investigator will submit once a year, throughout 
the trial, or on request a progress/safety report to the REC and R&D.  
 
 
10. STATISTICS AND ANALYSIS 
 
10.1. 
Description of Statistical Methods 
The data in this single arm study will be described by descriptive statistics only, using 
binomial confidence where necessary.  
 
10.2. 
The Number of Participants 
We will recruit 1100 - 2000 patients with an interim analysis at 1100 patients.  
 
The sample size is based on the paper:  
Pandit JJ. If it hasn't failed, does it work? On 'the worst we can expect' from observational trial 
results, with reference to airway management devices. Anaesthesia. 2012 Jun;67(6):578-83. 
That explains how binomial confidence intervals can be used in observational airway 
research of this type. 
The conclusions were: 
• 
Investigators in observational studies should state what they regard as ‘success’ or 
‘failure’ of using the device in question. Where the main endpoint is a continuous variable, 
researchers should define a justifiable threshold so that it can also be described as a 
caterogical (binomial) endpoint, 
• 
For all results, the upper limit of the 95% confidence interval (CI) should be quoted, 
• 
For airway devices such as SADs, a 95% CI upper limit failure rate > 2.5% (‘the worst we 
can expect’) in the chosen endpoint should generally lead to a conclusion that the device 
is poor or unsuitable for clinical use, compared with established devices, 
• 
In planning an observational trial, the minimum sample size should be calculated to yield 
(99% CI) for at least one failure of the device, which generally means that sample sizes 
should exceed 250, 
• 
Observational studies with < 250 patients are unlikely to provide useful evidence in 
favour of a device’s clinical acceptability, although they may provide useful information 
suggestive of its lack of acceptability. 
 
We followed all of these conclusions and our expected 1100 recruited patients are a lot more 
than the 250 expected to show a 2.5% failure rate with 95% CI. 
 
10.3. 
Analysis of Outcome Measures 

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The study will recruit up to 2000 patients, with an interim analysis at 1100 looking at the 
device failure rate. This is an observational study only. If we apply binomial confidence 
intervals according to the reference cited, and assume a ‘failure rate’ of clinical importance 
as 5%, we find an upper limit 95% CI of 6.54% with 1000 patients. For 2000 patients this 
upper limit is 6.05%. Thus, the gain of precision in studying up to 2000 patients may be very 
marginal if this is what an interim analysis at 1100 patients shows. We will however, continue 
the study if the ‘failure rate’ is >10% as then the precision in estimate benefit of studying 
2000 patients is greater. 
 
The data in this single arm study will be described by descriptive statistics only, using 
binomial confidence where necessary. 
 
11. DATA MANAGEMENT 
 
11.1. 
Access to Data 
Direct access will be granted to authorised representatives from the Sponsor and host 
institution for monitoring and/or audit of the study to ensure compliance with regulations. 
11.2. 
Data Recording and Record Keeping 
Data will be collected prospectively on data collection sheets completed by the anaesthetist 
/ investigator during anaesthesia. Each site will manage their own data set and the data will 
be pooled at the end of the recruitment phase across all sites. Data will be sent from sites to 
the lead study team only at the end of the data collection. 
Consent form and initial data collection forms will be filed in the master folder and kept 
locked in the dedicated research locker in the department. 
Each site will assign a study ID for each participant and a record of these IDs will be kept in 
the site file. Only anonymised data will be sent from each trust to the main study team. No 
personal data will be sent to the coordinating centre. 
 
Management of data at sites 
At each participating site participants will be assigned a trial ID at the moment of enrolment.  
The log of trial IDs and patient data will be kept in the site file in a locked cupboard in the 
anaesthetic department in each site. It will be separate to the CRF. The PI at each site will 
have access to this log.  
The trial ID will be noted on the CRF and the consent form.  
Data will be recorded by hand on the CRF by the investigator and later will be transcribed on 
a study database / excel spreadsheet kept on the Trust servers. The CRF will be identifiable 
by study ID only. 
The hard copies of the consent forms and CRF will be kept locally, but separately, in the 
anaesthetic departments in secure locked filling cabinets.  
Electronic data will be kept on a password protected database/excel spreadsheet stored on 
NHS servers on the hospital intranet of each site (this means it is backed up).  
Telephone numbers will be accessed from hospital records with the consent of the 
participant. If the investigator chooses to record the telephone number of patient, this will be 
recorded on a separate electronic file, not on the enrolment log, and the file will be destroyed 
within three months of the study ending.  The PI on each site will have access to the research 
files. Personal data be kept for 3 months and study data be kept for 5 years. 

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The only data that will be shared with the lead study team will be the data spreadsheet that 
will only have study IDs and no identifiable data. It will be sent electronically and the 
password will be sent separately to the spreadsheet.  
Data from the research sites will be shared with the lead sire only by using secure NHS email 
accounts. 
 
Management of data by lead study team 
The lead study team will receive the anonymised data spreadsheet, on which information will 
be recorded with study ID only.  
All the information will be collated and stored, anonymously, entered onto a central database 
on OUH trust servers, with each participant identifiable by the study ID.  
Study the data be kept for 5 years. 
 
12. QUALITY ASSURANCE PROCEDURES 
 
The study may be monitored, or audited in accordance with the current approved protocol, 
GCP, relevant regulations and standard operating procedures. 
 
13. ETHICAL AND REGULATORY CONSIDERATIONS 
 
13.1. 
Declaration of Helsinki 
The Investigator will ensure that this study is conducted in accordance with the principles of 
the Declaration of Helsinki. 
13.2. 
Guidelines for Good Clinical Practice 
The Investigator will ensure that this study is conducted in accordance with relevant 
regulations and with Good Clinical Practice. 
 
13.3. 
Approvals 
The protocol, informed consent form, participant information sheet and any proposed 
advertising material will be submitted to an appropriate Research Ethics Committee (REC), 
and HRA for written approval. 
The Investigator will submit and, where necessary, obtain approval from the above parties 
for all substantial amendments to the original approved documents. 
 
13.4. 
Reporting 
The CI shall submit once a year throughout the study, or on request, an Annual Progress 
report to the REC Committee, HRA (where required) host organisation and Sponsor. In 
addition, an End of Study notification and final report will be submitted to the same parties. 
 
13.5. 
Participant Confidentiality 
No participant identifiable data will be published. 
The study staff will ensure that the participants’ anonymity is maintained.  The participants 
will be identified only by a participant ID number on all study documents and any electronic 
database, with the exception of the CRF, where participant initials may be added.  All 
documents will be stored securely and only accessible by study staff and authorised 
personnel. The study will comply with the Data Protection Act, which requires data to be 
anonymised as soon as it is practical to do so. 
 

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13.6. 
Expenses and Benefits 
No payment will be made to participants. 
 
13.7. 
Other Ethical Considerations 
There are no other ethical issues involved in this study. 
 
14. FINANCE AND INSURANCE 
 
14.1. 
Funding 
The study is funded to the requested sum of £56,400, £20,000 of which would be paid 
immediately for consumables and the rest to be held as a contingency if needed, and there is 
no time limit although DAS reserves the right to withdraw the funds from January 2022.  
Costs of devices are covered by a grant from the Difficult Airway Society (DAS) to the 
University of Oxford for the sum of £15,400. The rest of the grant money is for a PhD through 
DAS and has no bearing with the funds available for the study. We are awaiting an invoice 
from DAS that soon should be raised and we will (via the university) pay this sum over to 
them, soon after which the devices will arrive. 
 
Each research site will obtain the devices directly from the central store area. The orders will 
be placed with the company Teleflex, and on the orders will be specified which site to send 
the devices to. Once the order is placed the company will ship them as required. 
 
Each researcher is a consultant with an NHS contract. This consists of Direct Care 
Programmed Activities (DCC) and Supporting Professional Activity (SPA). The latter is, 
within the contract, up to 10 hours per week, and is assigned to activities including research 
and quality improvement. If a consultant does not deliver on these goals or use that paid time 
for these activities s/he is in breach of contract. Moreover, if they seek or take additional 
payment for these activities then they are being paid twice for the same work which is illegal. 
Moreover, the use of SPA time (up to 10 hours/wk) in any given year is specified at Appraisal 
which is a mandatory and directional meeting to assign goals for the coming year. Therefore, 
this project is explicitly factored in to the fully funded development goals. 
 
A study coordinator will be put in place covered by funding from the Difficult Airway society. 
 
14.2. 
Insurance 
NHS bodies are legally liable for the negligent acts and omissions of their employees. If you 
are harmed whilst taking part in a clinical research study as a result of negligence on the part 
of a member of the study team this liability cover would apply. 
Non-negligent harm is not covered by the NHS indemnity scheme. The Oxford University 
Hospitals NHS Foundation Trust, therefore, cannot agree in advance to pay compensation in 
these circumstances. 
In exceptional circumstances an ex-gratia payment may be offered. 
 
15. PUBLICATION POLICY 
 
The Investigators will be involved in reviewing drafts of the manuscripts, abstracts, press 
releases and any other publications arising from the study.  Authors will acknowledge that 

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the study was funded by DAS. Authorship will be determined in accordance with the ICMJE 
guidelines and other contributors will be acknowledged. 
 
 

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16. REFERENCES 
 
1. Teleflex Medical Inc. Instructions for use – LMA Classic ExcelTM. Teleflex Medical Inc., 
North Carolina, USA, 2013. Viewed 20th March 2017, <http://www.lmaco-
ifu.com/sites/default/files/node/1898/ifu/revision/2921/paa2100001c.pdf>. 
2. Frerk C et al. Difficult Airway Society 2015 guidelines for management of 
unanticipated difficult intubation in adults. British Journal of Anaesthesia, 2015; 
115(6): 827-848. 
3. Royal College of Anaesthetists. Fourth National Audit Project of the Royal College of 
Anaesthetists and Difficult Airway Society. Major complications of airway 
management in the United Kingdom. Report and Findings. Editors Cook TM, Woodall 
N, Frerk C. March 2011. Royal College of Anaesthetists, London. Viewed 20th March 
2017, <http://www.rcoa.ac.uk/system/files/CSQ-NAP4-Full.pdf>.  
4. Woodall N, Cook TM. A national census of airway management techniques employed 
during anaesthesia in the UK: results of the first phase of the 4th National Audit Project 
at the Royal College of Anaesthetists. British Journal of Anaesthesia, 2011; 106: 266-
271. 
5. Intersurgical Ltd. I-gel User Guide. Intersurgical Ltd, Berkshire, UK, 2016. Viewed 20th 
March 2017 http://www.intersurgical.co.uk/content/files/80023/1103318462. 
6. Teleflex Medical Inc. Instructions for use – LMA ProSealTM. Teleflex Medical Inc, North 
Carolina, 
USA, 
2015. 
Viewed 
20th 
March 
2017, 
<http://www.lmaco-
ifu.com/sites/default/files/node/388/ifu/revision/4838/ifu-lma-proseal-
pab2100001buk.pdf>. 
7. De Montblanc J et al. A systematic review and meta-analysis of the i-gel® vs laryngeal 
mask airway in adults. Anaesthesia, 2014; 69: 1151-1162. 
8. Cook TM et al. The ProsealTMlaryngeal mask airway: a review of the literature. 
Canadian Journal of Anaesthesia, 2005 ;52(7): 739-760. 
9. Maitra S, Khanna P, Baidya DK. Comparison of laryngeal mask airway Supreme and 
laryngeal mask airway Pro-Seal for controlled ventilation during general anaesthesia 
in adult patients, 2014; 31: 266-273.  
10. Pajiyar AK et al. Comparisons of clinical performance of guardian laryngeal mask with 
laryngeal mask airway ProSeal. BMC Anesthesiology, 2015; 15: 69.  
11. Cook TM, Kelly FE. Time to abandon the ‘vintage’ laryngeal mask airway and adopt 
second-generation supraglottic airway devices as first choice. Anaesthesia, 2015; 
115(4): 497-499. 
12. Pandit JJ et el. The Difficult Airway Society ‘ADEPT’ Guidance on selecting airway 
devices: the basis of a strategy for equipment evaluation. Anaesthesia, 2011; 66: 726-
737. 
13. Teleflex Medical Inc. LMA ProtectorTM instructions for use. Teleflex Medical Inc., North 
Carolina, 
USA, 
2015. 
Viewed 
20th 
March 
2017, 
<http://www.lmaco-
ifu.com/sites/default/files/node/1928/ifu/revision/3285/pbe2100000b-lma-
protector-ifuuk.pdf>. 
14. Sng BL et al. A preliminary assessment of the LMA ProtectorTM in non-paralysed 
patients. BMC Anesthesiology, 2017; 17: 26.  
15. Van Zundert AAJ, Gatt SP, Kumar CM, Van Zundert TCRV, Pandit JJ. Br J Anaesth. 2017 
May 1;118(5):645-649. 
 
 

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17. APPENDIX A:  STUDY FLOW CHART 
SCHEDULE OF OBSERVATIONS 
 
SAD insertion time 
(from picking up device until upstroke of 1st square wave capnography trace) 
SAD insertion attempts 
Cuff volume to achieve 60cmH2O cuff pressure 
Leak pressure: 
pressure at which audible leak starts or airway pressure plateaus, with fresh gas flow 
set at 5L/ min  
Score following parameters using 11-point NRS 
(0 –  very difficult / inadequate, 10 – very easy / excellent) 
Ease of insertion 
Adequacy of ventilation 
Hands free anaesthesia or overall usefulness of device 
Note airway manipulations to maintain airway: 
Additional Neck extension 
Neck flexion 
Chin lift 
Additional Jaw thrust 
Note following complications during device insertion / airway maintenance / 
removal of device: 
Failure to establish airway 
Loss of adequate airway 
Soft tissue damage 
Dental damage 
Regurgitation 
Aspiration 
Laryngospasm 
Stridor 
Coughing 
Gagging 
Hiccough 
Desaturation 
After surgery note following events: 
Vomiting 
Lip or tongue swelling 
Hearing changes 
Ear pain 
Sore throat 
Dysphagia 
Sore jaw 
Dysphonia 
Numbness of tongue / oropharynx 
Pain on speaking 
Neck or mouth ache 
 
 
 

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18. APPENDIX C:  AMENDMENT HISTORY 
 
Amendment 
No. 
Protocol 
Version 
No. 
Date 
issued 
Author(s) of changes 
Details of Changes 
made 
 
 
 
 
 
 
List details of all protocol amendments here whenever a new version of the protocol is 
produced.  This is not necessary prior to initial REC submission.