Fibre-optic Guided Tracheal Intubation Through Supraglottic Airway Devices - a Randomised Comparison Between I-gel and the LMA ProtectorTM
Phase: NA
Conditions: Intubation; Difficult or Failed, Laryngeal Masks, Airway Management
Sponsor: University Hospitals Coventry and Warwickshire NHS Trust

 
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Version 1.0. 28-Feb-2017 
 
 
 
Fibre-optic guided tracheal intubation through supraglottic airway 
devices – a randomised comparison between I-gel and the LMA 
ProtectorTM 
 
Fibre-optic guided tracheal 
intubation through SAD’s 
 
Version 1.0 28-Feb-2017  
 
 
Sponsor:  University Hospitals Coventry & Warwickshire NHS Trust  
Sponsor reference: CM176716 
 
REC reference: 17/LO/0570 
 
IRAS No:  210065 
Clinical trials.gov number: NCT03118596 
 
 
 
 
 
 
 
Confidentiality statement 
All information contained within this document is regarded as, and must be kept, confidential. No part of 
this document may be disclosed to any Third Party without the written permission of the Chief Investigator 
and/or Sponsor. 
 
 

 
Fibre-optic guided tracheal intubation through SAD’s 
 
 
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SIGNATURE PAGE 
The undersigned confirm that the following protocol has been agreed and accepted and that the Chief 
Investigator agrees to conduct the trial in compliance with the approved protocol and will adhere to the 
principles outlined in the Research Governance Framework, the ICH Good Clinical Practice guidelines and 
the Sponsor’s SOPs. 
I agree to ensure that the confidential information contained in this document will not be used for any other 
purpose other than the evaluation or conduct of the clinical investigation without the prior written consent 
of the Sponsor. 
I also confirm that I will make the findings of the study publically available through publication or other 
dissemination tools without any unnecessary delay and that an honest accurate and transparent account 
of the study will be given; and that any discrepancies from the study as planned in this protocol will be 
explained. 
 
 
For and on behalf of the Study Sponsor: 
Signature:  
 
...................................................................................................... 
 
Date:  
 
......../…..../…..... 
Name (please print): 
 
...................................................................................................... 
 
 
Position:  
 
...................................................................................................... 
 
 
 
 
 
Chief Investigator: 
Signature:  
 
...................................................................................................... 
 
Date:  
 
…...../......../........ 
Name: (please print): 
 
Prof. Cyprian Mendonca 
Position: Consultant Anaesthetist 
 
 
 
 
 

 
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KEY TRIAL CONTACTS 
Chief Investigator 
Professor Cyprian Mendonca 
Department of Anaesthesia 
University Hospital, Coventry, CV2 2DX 
Contact no: 02476964000 bleep 1865 
Co-investigators 
Dr Vassilis Athanassoglou 
Oxford University Hospitals NHS Foundation Trust 
Oxford 
Contact no: 07971006906 
Sponsor 
Ceri Jones  
UHCW NHS Trust, Clifford Bridge Road, Coventry CV2 2DX 
Contact No: 02476 965031 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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TRIAL SUMMARY 
Full study title 
Fibre-optic guided tracheal intubation through supraglottic 
airway devices – a randomised comparison between I-gel 
and the LMA ProtectorTM 
Short study title 
Fibre-optic guided tracheal intubation through SAD’s 
Trial Design 
Multi – centre randomised  
Trial Participants 
All patients aged 18 and above, presenting for elective 
surgical procedure where a supraglottic airway device can be 
used.  
Planned Sample Size 
180 across 2 sites  
Follow up duration 
0 months  
Planned Trial Period 
12-14months  
 
Objectives 
Outcome Measures 
Primary 
 
Successful tracheal 
intubation 
Time form insertion of from 
insertion of scope till end-tidal 
CO2 
Secondary 
 
Successful placement of 
supra-glottic airway device 
Number of attempts 
Time taken to insert 
supra-glottic airway 
device 
 
Key Words: Intubation; tracheal, airway device; supra-glottic airway device, fibreoptic scope. 
 
 
 
 
 
 
 
 
 
 

 
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TRIAL FLOW CHART 
Figure 1: Flow of participants through the study 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Monitored, IV access secured- Randomised 
Pre-oxygenated and GA induced 
Igel or LMA Protector inserted 
Fibreoptic  intubation via Igel or LMA Protector completed 
Study end- Rest of the anaesthetic procedure continued as normal 
Participant approached, information given  
Consent obtained 
Patient arrived into anaesthetic room 

 
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SCHEDULE OF OBSERVATIONS 
Table 1: Schedule of measures  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
SAD insertion time  
(from insertion into the mouth of until 1st capnography trace is obtained) 
SAD insertion score: 
 1-easy, 2 – mild difficulties, 3 – difficult, 4 - failure 
SAD insertion attempts 
Leak pressure:  
pressure at which audible leak starts, set flow at 6L/ mins and increase the 
APL valve pressure. 
FOI: View grade 
grade I – full view of the vocal cord, II – partial view of the vocal cords & 
arytenoids, III – epiglottis only, IV – other (SAD cuff, pharynx, others) 
FOI: Time to view carina:  
time from insertion of scope into the SAD lumen ending with visualization of 
the carina 
FOI: Total intubation time  
(from insertion scope through SAD until 1st capnography trace is obtained) 
No of attempts at intubation 
Operator’s visual analogue score: 0 to 10  
(0 being very difficult, 10 being very easy) 
Difficulty observed: 
 tube rotation, tube impingement, failure to intubate 
Surgery: 
Duration of surgery in minutes 

 
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LIST of CONTENTS 
GENERAL INFORMATION 
Page No. 
TITLE PAGE  
 
RESEARCH REFERENCE NUMBERS 
 
 
SIGNATURE PAGE 
 
KEY TRIAL CONTACTS 
 
 
TRIAL SUMMARY 
 
 
TRIAL FLOW CHART 
 
SCHEDULE OF OBSERVATIONS 
 
LIST OF CONTENTS  
 
LIST OF ABBREVIATIONS 
 
 
 
SECTION 
1. INTRODUCTION  
 
2. TRIAL DESIGN 
 
3. STUDY SETTING 
 
4. ELIGIBILITY CRITERIA 
 
5. TRIAL PROCEDURES 
 
6. STATISTICS AND DATA ANALYSIS 
 
7. DATA HANDLING 
 
8. TRIAL OVERSIGHT 
 
9. MONITORING, AUDIT & INSPECTION 
 
10. ETHICAL AND REGULATORY CONSIDERATIONS 
 
11. DISSEMINATION POLICY 
 
12. REFERENCES 
 
 

 
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LIST OF ABBREVIATIONS 
 
 
 
 
 
 
 
 
 
 
LIST OF ABBREVIATIONS 
  
CI 
Chief Investigator 
GCP 
Good Clinical Practice 
ICF 
Informed Consent Form 
ICH 
International Conference on Harmonisation 
of technical requirements for registration of 
pharmaceuticals for human use. 
ISF 
Investigator Site File 
NHS R&D 
National Health Service Research & 
Development   
NIMP 
Non-Investigational Medicinal Product 
PI 
Principal Investigator 
PIS 
Participant Information Sheet 
QA 
Quality Assurance 
QC 
Quality Control 
RCT 
Randomised Control Trial 
REC 
Research Ethics Committee 
SAE 
Serious Adverse Event 
SAD                                                        Supraglottic Airway device (Igel and LMA 
protector) 
SOP 
Standard Operating Procedure  
SSI 
Site Specific Information 
SUSAR 
Suspected Unexpected Serious Adverse 
Reaction  
TMF 
Trial Master File 
 
 

 
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STUDY PROTOCOL 
Fibre-optic guided tracheal intubation through supraglottic airway devices – a randomised 
comparison between I-gel and the LMA ProtectorTM 
 
 
 
 
 
1. 
INTRODUCTION 
Intubation through supraglottic airway devices (SAD) is a well-established technique in the management of 
patients with difficult airway. The passage of the endotracheal tube into the trachea using the SAD as a 
conduit can be performed blindly or with the use of a fiberoptic scope to guide intubation. The recently-
published “Difficult Airway Society guidelines for management of unanticipated difficult intubation in adults” 
strongly emphasise the importance of minimising the number of airway interventions during a difficult 
airway scenario [1]. Hence, it is recommended that blind technique, with its lower success rate should no 
longer be used. In a patient where tracheal intubation is planned and when the initial plan (plan A) fails 
guideline recommends declaring the failure and moving on to plan B. Plan B involves securing the airway 
using a second a SAD. Guideline recommends use of second generation SAD due to added benefit of 
minimising gastric aspiration. Once the situation is stable, tracheal intubation can be performed through 
SAD using fiberoptic scope (camera device).   
 
There are two second generation supraglottic airway devices, currently available: I-gel and LMA 
ProtectorTM that allow tracheal intubation.  
 
The I-gel is a second generation supraglottic airway device widely used in anaesthesia and resuscitation. 
Fiberoptic intubation through the I-gel has been evaluated in a recent prospective study, with the first 
attempt success rate of 91.4% (Taxak). In another study of patients with predicted difficult airway the 
success rate of the procedure at first attempt was 96%. (Kleine-Brueggeney) 
 
LMA Protector is a recently introduced improved version LMA supreme another second generation 
supraglottic airway device. LMA supreme has been used in clinical practice for more than 10 years. But 
tracheal intubation through LMA supreme was extremely difficult because of the smaller breathing 
channel. Hence the improvised version has larger breathing channel. Compared to I-gel, this has larger 
gastric drainage tube and allows easy suction in the event of regurgitation. Therefore, in preventing the 
aspiration risk, LMA protector device appears to be superior to I-gel.  
 
We are not aware of any study comparing these two devices for fiberoptic (camera) assisted tracheal 
intubation.  
 
Comparing the efficacy of these devices in adults could in future guide the anaesthetists’ choice of the 
SAD used in the difficult airway scenario, and also help the anaesthetists take informed decisions when 
using SADs to intubate the trachea in elective settings.   
2. RATIONALE  
2.1 Aims and hypothesis 
The aim of this study is to compare the fiberoptic guided tracheal intubation through I gel supraglottic 
airway to that of LMA protector supraglottic airway device. Our hypothesis is that intubation through I –
gel is easier and quicker.  
Justification 

 
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The recently-published “Difficult Airway Society guidelines for management of unanticipated difficult 
intubation in adults” strongly emphasise the importance of minimising the number of airway interventions 
during a difficult airway scenario.  When the initial plan (Plan A) of tracheal intubation (process of placing 
the breathing tube in to the wind pipe using initial method) fails, one should move on to plan B. Plan B 
involves placing supraglottic airway device and maintaining oxygenation. Once the oxygenation is stable, 
further attempt at intubation can be performed through the supraglottic airway device using fiberoptic 
scope. Supraglottic Airway Device-a type airway tube placed in the oral cavity (oropharynx) is used as 
conduit for passing the camera known as fiberoptic scope. Once the fiberoptic scope is placed in the 
wind pipe, the tracheal tube is railroaded over the fiberoptic scope. 
DAS guidelines recommend to use second generation supraglottic airway device. The key feature of 
second generation supraglottic airway device is the ability to minimise the risk of aspiration.  
The I-gel is a second generation supraglottic airway device widely used in anaesthesia and resuscitation. 
LMA Protector is a recently introduced improved version LMA supreme another second generation 
supraglottic airway device. LMA supreme has been used in clinical practice for more than 10 years. But 
tracheal intubation through LMA supreme was difficult because of the smaller breathing channel. Hence 
the improvised version has larger breathing channel. The LMA protector has a larger breathing channel 
and hence can be used a conduit for tracheal intubation. Compared to I-gel, LMA protector has a larger 
gastric drainage tube and allows easy suction in the event of aspiration. Therefore, in preventing the 
aspiration risk, LMA protector device appears to be superior to I-gel. 
The data comparing the efficiency of fibre-optic guided intubation using the above supraglottic airway 
devices in adults are so far lacking. Comparing the efficacy of these devices in adults could in future 
guide the anaesthetists’ choice of the supraglottic airway device used in the difficult airway scenario, and 
also help the anaesthetists take informed decisions when using SADs to intubate the trachea in elective 
settings.   
 
2.3 
Assessment and management of risk 
Supraglottic airway device routinely used in clinical practice as an airway during general anaesthesia 
involving minor surgery. For this study patients requiring general anaesthesia and tracheal intubation will 
be selected. We do not anticipate any additional risks or benefits to the study participants.  During the 
process of intubation, peripheral oxygen saturation is closely monitored.  
 
3 
OBJECTIVES AND OUTCOME MEASURES/ENDPOINTS 
3.1 
Primary objective 
The aim of the study is to establish which of the two Supraglottic Airway Devices (a type airway tube 
placed in the oral cavity) is best suited for tracheal intubation (the process of placing the breathing tube in 
to the wind pipe). The process of placing the breathing tube is guided using fibre-optic scope (a camera 
device) through the Supraglottic Airway Device. The primary outcome of this will be time to complete the 
intubation.  
Supraglottic Airway Device (a type airway tube placed in the oral cavity/oropharynx) is used as conduit for 
passing the camera (known as fiberoptic scope) to the wind pipe. Once the fiberoptic scope is paced in the 
wind pipe, the tracheal tube is railroaded over the fiberoptic scope and fiberoptic scope is removed. The 
breathing tube is then connected to the anaesthetic machine. 
 
3.2 
Secondary objectives 

 
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The results of the study should reveal whether there is a significant difference in the ease of intubation (the 
process of placing the breathing tube in to the wind pipe) and success rate between two supraglottic 
airway devices. 
 
3.3 
Primary endpoint/outcome 
Time to successful tracheal intubation: defined as the duration of time from insertion of scope through the 
supraglottic airway device, ending with the observation of a first square wave end-tidal capnography trace. 
 
3.4 
Secondary endpoints/outcomes 
 
Number of attempts at the SAD placement 
 
SAD insertion time: defined as the duration of time SAD picked up in the hand, ending with the 
observation of a first square wave end-tidal capnography trace. 
 
Number of attempts at tracheal intubation 
 
The ease of placement of the SAD; 1-easy, 2 – mild difficulties, 3 – difficult, 4 - failure 
 
The fiberoptic quality of the laryngeal view (seen through the SAD) will be assessed, according to the 
previously published system, as: grade I – full view of the vocal cord, II – partial view of the vocal cords 
including arytenoids, III – epiglottis only, IV – other (SAD cuff, pharynx, others) (Joffe 2011) 
 
Time to carinal view: defined as the duration of time from insertion of scope into the SAD lumen ending 
with visualization of the carina.  
 
The number and type of airway manoeuvres performed during tracheal intubation 
 
Peri-operative complications 
 
4 
TRIAL DESIGN 
Multi-centre randomised-controlled trial  
 
5 
STUDY SETTING 
The study will be conducted in 2 hospitals in England. University Hospitals Coventry & Warwickshire NHS 
Trust and Oxford University Hospitals.  
 
6 
ELIGIBILITY CRITERIA.  
6.1 
Inclusion criteria 
All patients aged above 18, presenting for elective surgical procedure, where a supraglottic airway device 
can be used and left in place throughout the duration of surgery and requiring tracheal intubation will be 
invited to take part in the study. This involves a group of patients presenting for abdominal surgery and 
peripheral limb operation where tracheal intubation is indicated.  
 
6.2 
Exclusion criteria 
 
Patients who are do not want  to take part or do not give consent 
 
Patients with class II obesity (BMI >40) 
 
Patients below 18 years of age 
 
ASA 3, 4 and 5,  
 
Patients with mouth opening of less than 3 cm 

 
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 
Patients deemed to require awake intubation 
 
Surgery involving head and neck region 
 
Surgery requiring prone position 
 
7 
TRIAL PROCEDURES  
 
The suitable patients for the study will be screened from the operating theatre list. During the preoperative 
assessment one of the investigator or co-investigator will provide patient information sheet. Patients will be 
given adequate time to read the information and any questions will be answered. If they are satisfied and 
willing to take part in the study, written consent will be obtained. 
 
7.1 
Recruitment 
Both Chief investigator and co-investigators identify the suitable operating list. Then the suitable patients 
will be identified based on the scheduled surgical procedure. Only those patients meeting the inclusion 
criteria will be approached.  
 
7.1.1 Patient identification 
The patients undergoing surgery that requires tracheal intubation are suitable to be included in the study. 
Based on the scheduled surgery on the operating list, the suitable patients will be identified. During the 
preoperative assessment one of the investigator or co-investigator will provide patient information sheet. 
Patients will be given adequate time to read the information and any questions will be answered. If they are 
satisfied and willing to take part in the study, written consent will be obtained. 
 
 
7.2 Consent  
Participants will be given enough time to read the patient information leaflet (minimum of 2 hours). Once 
 they have read the information, any questions will be answered. If they agree for the study, they will be 
asked to complete the consent form. The consent will be obtained by chief investigator, coinvestigator or 
one of the research team member, supervised by one of the investigator.  
7.3 Randomisation scheme  
Randomisation for this study will be completed on a 1:1 basis via sealed envelopes. The Statistician will 
create 2 master randomisation lists for each site and the envelopes will be numerically ordered.  
On arrival to the anaesthetic room, sealed envelope will be opened to reveal the group.  Based on the group, 
following induction of general anaesthesia, the chosen supraglottic airway device will be inserted. Once the 
supraglottic airway device placement confirmed, tracheal intubation is completed using Fiberoptic scope. 
The randomisation will determine which supraglottic airway device to choose. Rest of the process is similar in 
both groups. 
In theatre once the envelopes have been opened the randomisation log will need to be completed. The 
envelopes containing the assigned device will be retained in a folder in theatre.  
7.5 Baseline data 
Base line data includes gender, age, weight, height, BMI & ASA score 
Airway assessment includes Mallampati score, thyromental distance, mouth opening and neck movement  
 
7.6 
Trial assessments 

 
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Time taken to insert supraglottic airway device 
Ease of SAD insertion and number of attempts 
View of the larynx through fiberoptic scope 
Time to view the carina (end of wind pipe) 
Total intubation time  
No of attempts 
Anaesthetist’s visual analogue score on the ease of procedure 
Any additional manoeuvres required such as tube rotation or jaw thrust 
 
 
8 
DATA HANDLING 
8.1 
Data collection tools and source document identification 
 
 
CRFs will completed at the time of data collection  
 
 
No other data collection is required 
 
8.2 Data handling and record keeping 
Consent forms and CRFs will be filed into the investigator site file and the data is then entered at regular 
interval into the excel sheet on an encrypted NHS computer. 
 
8.3 Access to Data 
Direct access will be granted to authorised representatives from the Sponsor, host institution and the 
regulatory authorities to permit trial-related monitoring, audits and inspections. 
 
8.4 Archiving 
Research data will be stored off site in a secure approved NHS access facility - TNT. Only the 
research team will have authority to access this data if required via a request to the R&D 
Archiving Team. The study will be archived for 25 years from the close of the study with a review 
1 year before the anticipated destruction date 
 
9. TRIAL OVERSIGHT 
9.1 Role and responsibilities of the Sponsor 
UHCW has agreed to act as sponsor for this trial and will undertake the responsibilities of sponsor as 
defined by the Research Governance Framework and ICH Good Clinical Practice. An authorised 
representative of the Sponsor has approved the final version of this protocol with respect to the trial 
design, conduct, data analysis and interpretation and plans for publication and dissemination of results. 
As sponsor, UHCW provides indemnity for this trial and, as such, will be responsible for claims for any 
non-negligent harm suffered by anyone as a result of participating in this trial. The indemnity is renewed 
on an annual basis and will continue for the duration of this trial. 
 

 
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9.2 Principal Investigators 
 “Site Principal Investigator responsibilities include, but are not limited to: 
 Ensuring that the trial is conducted as set out in the protocol and supporting documents 
 Delegating trial related responsibilities only to suitably trained and qualified personnel and ensuring 
that those with delegated responsibilities fully understand and agree to the duties being delegated 
to them; 
 Ensuring that CVs and evidence of appropriate training for all Site staff are available in the Trial 
Site File 
 Ensuring that all delegated duties are captured in the study Delegation Log 
 Ensuring the trial is conducted in accordance with ICH GCP principles;  
 Allowing access to source data for monitoring, audit and inspection; 
 Ensuring that all source data is complete and provided to the chief investigator  
 
10. MONITORING, AUDIT & INSPECTION 
 
The study will be monitored by the Research & Development department at UHCW as representatives of 
the Sponsor, to ensure that the study is being conducted as per protocol, adhering to Research 
Governance and GCP. The approach to, and extent of, monitoring will be specified in a trial monitoring 
plan determined by the risk assessment undertaken prior to the start of the study.”  
 
11. 
ETHICAL AND REGULATORY CONSIDERATIONS 
11.1   Ethical approval and research governance 
 
The study will be conducted in compliance the principles of the ICH GCP guidelines and in accordance 
with all applicable regulatory guidance, including, but not limited to, the Research Governance 
Framework. Ethical approval for this study will be sought from the Research Ethics Committee combined 
with Health Research Authority (HRA) approval. No study activities will commence until favourable ethical 
opinion and HRA approval has been obtained. Progress reports and a final report at the conclusion of the 
trial will be submitted to the approving REC within the timelines defined by the committee. Confirmation 
of capacity and capability will be obtained from the R&D departments obtained prior to commencement of 
the study at all participating sites. 
 
 
 
11.2  
Peer review 
One external and internal review has been completed.  
 
11.4  Data protection and patient confidentiality 

 
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The study will comply with the Data Protection Act 1998. Participants will be assigned a unique identifier 
upon enrolment in to the study to allow link-anonymisation of patient-identifiable data. Access to patient 
identifiable data will be restricted to members of the study co-ordination team who require it for the 
performance of their role.  Electronic data will be stored on password protected encrypted drives and hard 
copies of study documents will be stored in locked filing cabinets in secure entry-card protected sites. 
 
 
12  
DISSEMINATION POLICY 
The study finding will be first presented as an abstract at national meetings and subsequently published in 
Anaesthesia peer reviewed journal. 
 
 
13 
REFERENCES 
 
1. Frerk CM, Mitchell VS, McNarry AF, et al. Difficult Airway Society 2015 guidelines for the 
management of unanticipated difficult intubation in adults. Br J Anaesth 2015; 115: 827-
48. 
2. Taxak S, Kaur KP, Ahlawat G, Bhardwaj M, A study to evaluate fibreoptic-guided 
intubation through the i-gel™, South Afr J Anaesth Analg 2013;19(2):120-123 
 
3. M. Kleine-Brueggeney, L. Theiler , N. Urwyler, A. Vogt,  R. Greif, Randomized trial 
comparing the i-gelTM and Magill tracheal tube with the single-use ILMATM and ILMATM 
tracheal tube for fibreoptic-guided intubation in anaesthetized patients with a predicted 
difficult airway British Journal of Anaesthesia 107 (2): 251–7 (2011) 
4. El-Ganzouri AR, Marzouk S, Abdelalem N, Yousef M, Blind versus fiberoptic 
laryngoscopic intubation through air Q laryngeal mask airway, Egyptian Journal of 
Anaesthesia (2011) 27, 213–218 
5. Samir EM, Sakr SA, The air-Q as a conduit for fiberoptic aided tracheal intubation in adult 
patients undergoing cervical spine fixation: A prospective randomized study, Egyptian 
Journal of Anaesthesia (2012) 28, 133–137 
6. Jagannathan et al, A randomized comparison between the i-gelTM and the air-QTM 
supraglottic airways when used by anesthesiology trainees as conduits for tracheal 
intubation in children, Can J Anaesth. 2015 Jun;62(6):587-94 
7. Weingart SD, Levitan RM. Preoxygenation and Prevention of Desaturation During 
Emergency Airway Management. Annals of Emergency Medicine 2011  
8. Du Rand A, Blaikley J, Booton R.British Thoracic Society Guideline for Diagnostic Flexible 
Bronchoscopy in Adults 
9. Joffe AM, Liew EC, Galgon RE, et al. The second-generation air-Q_ intubating laryngeal 
mask for airway maintenance during anaesthesia in adults: a report of the first 70 uses. 
Anaesth Intens Care 2011;39:40–5. 
10. Joffe AM, Liew EC, Galgon RE, et al. The second-generation air-Q_ intubating laryngeal 
mask for airway maintenance during anaesthesia in adults: a report of the first 70 uses. 
Anaesth Intens Care 2011;39:40–5.