CTRI Number CTRI/2023/11/060262 [Registered on: 28/11/2023] Trial Registered Prospectively
Last Modified On: 14/03/2024
Post Graduate Thesis Yes
Type of Trial Observational
Type of Study
Randomized controlled trial
Study Design Other
Public Title of Study
comparing the efficacy of two different types of supraglottic airway devices
Scientific Title of Study
Comparison of placement efficacy of inflatable cuff & non-inflatable cuff
supraglottic airway device when used by trainee anaesthesiologists in patients
under general anaesthesia
Trial Acronym
Secondary IDs if Any
Secondary ID Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name DrAmit Rastogi
Designation Additional Professor
Affiliation SanjayGandhi Postgraduate institute of medical sciences
Address SanjayGandhi Postgraduate institute of medical sciences,Department of Anaesthesiology.
Phone 9793124468
Fax
Email amit.rastogi.sgpgi@gmail.com
Details of Contact Person
Name
DrAmit Rastogi
Designation Additional Professor
Affiliation SanjayGandhi Postgraduate institute of medical sciences
Address SanjayGandhi Postgraduate institute of medical sciences,Department of Anaesthesiology.
Phone 9793124468
Fax
Email amit.rastogi.sgpgi@gmail.com
Details of Contact Person
Name Dr.Esther
Designation Junior Resident
Affiliation SanjayGandhi Postgraduate institute of medical sciences
Address SanjayGandhi Postgraduate institute of medical sciences,Department of Anaesthesiology.
Phone 8179407269
Fax
Email estherowk@gmail.com
Source of Monetary or Material Support
SanjayGandhi Postgraduate institute of medical sciences
Primary Sponsor
Name Dr.Amit Rastogi
Address SanjayGandhi Postgraduate institute of medical sciences,Department of Anaesthesiology,Lucknow
Type of Sponsor Other [self]
Details of Secondary Sponsor
Countries of Recruitment
India
Sites of Study
No of Sites = 1
Name of Principal
Investigator Name of Site Site Address Phone/Fax/Email
DrAmit Rastogi
Sanjay Gandhi Postgraduate Institute of medical sciences,Lucknow
Department of Anaesthesiology,Lucknow,Uttar Pradesh-226014
9793124468
Details of Ethics Committee
No of Ethics Committees= 2
Name of Committee Approval Status
129th Institutional Ethics Committee ,Sanjay Gandhi Postgraduate Institute of Medical Sciences,
Approved
Institutional ethics committee,sgpgi,Lucknow
Approved
Regulatory Clearance Status from DCGI
Health Condition / Problems Studied
Health Type Condition
Patients
(1) ICD-10 Condition:
Intervention / Comparator Agent
Inclusion Criteria
Age From 18.00 Year(s)
Age To 65.00 Year(s)
Gender Both
Details 1. ASA I and II patients
ExclusionCriteria
Details 1. Patients unable (legally incompetent) or unwilling to give consent.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Case Record Numbers
Blinding/Masking
Not Applicable
Primary Outcome
Outcome TimePoints
To determine oropharyngeal leak pressure of Non-inflatable SAD I-gel and inflatable
Immediate
Secondary Outcome
Outcome TimePoints
First-time insertion success rate of Non-inflatable LMA i-gel versus inflatable LMA
Immediate & till 24 hours post surgery
Target Sample Size
Total Sample Size= "130"Sample Size from India= "130" Final Enrollment numbers achieved (Total)= "0" Final Enrollment numbers achieved (India)= "0"
Phase of Trial
N/A
Date of First Enrollment (India)
05/12/2023
Date of Study Completion (India) Date Missing
Date of First Enrollment (Global) Date Missing
Date of Study Completion (Global) Date Missing
Estimated Duration of Trial
Years= "1"Months= "3"Days= "0"
Recruitment Status of Trial (Global)
Modification(s)
Not Applicable
Recruitment Status of Trial (India) Completed
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
What data in particular will be shared?Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
What additional supporting information will be shared? Response - Study ProtocolResponse - Statistical Analysis PlanResponse - Informed Consent FormResponse - Clinical Study Report Who will be able to view these files?Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
For what types of analyses will this data be available?Response - To achieve aims in the approved proposal.
By what mechanism will data be made available?Response (Others) - Institute bioethics cell archival
For how long will this data be available start date provided 05-03-2025 and end date provided 05-03-2030 ?Response (Others) - 3-5 years after completion of study
Any URL or additional information regarding plan/policy for sharing IPD? Additional Information - nil
Brief Summary
The prototypical supraglottic airway device (SAD) was invented by Dr Archie Brain in 1983.Its
role has since evolved, substituting the clinical space of what traditionally was occupied by mask
ventilation and tracheal intubation. These are a group of airway devices that are inserted into
pharynx for ventilation. SADs may be broadly classified as cuffed peri-laryngeal sealers, cuffed
pharyngeal sealers and cuff-less anatomically pre-shaped sealers. According to evolution they
can also be classified as 1st and 2nd generation devices, where the 2nd generation devices are
designed to protect against aspiration with a gastric channel resulting in better seal pressures.
The 2nd generation SADs appear to out-perform the 1st generation devices in efficacy, safety
and suitability for advance uses. Despite these recent advances, SADs still have several
limitations which include the risk of aspiration, inadequate positive pressure ventilation,
potential loss or blockage of airway, and air leakage from incorrectly sized SAD or hyperinflated
cuff [1]. The airway pressure at which gas leaks into the oropharyngeal space is known as
oropharyngeal leak pressure (OLP). OLP value is a measure of successful placement followed
by functioning of SAD. Several studies have been done for the OLP measurements during
various SAD insertions [1-5]. SAD’s have several advantages over endotracheal tubes
[12,13]Provides smooth induction of anaesthesia without much hemodynamic instability.
Insertion is easier & faster than intubation especially for those unfamiliar with endotracheal
intubation. Anesthesia with endotracheal intubation, although accompanied by a low incidence
of complications requires the use of neuromuscular blocking agents, and has a longer extubation
and recovery times. The I-gel (Intersurgical Ltd, Wokingham, Berkshire, UK) is a supraglottic
airway device with an anatomically designed non-inflatable mask that snugly fits onto the peri
laryngeal framework. The device has a buccal cavity stabiliser with an airway channel and a
gastric tube insertion channel [6,14].Ambu Aura GainTM(Ambu,Ballerup,Denmark) is a
relatively novel supraglottic airway device which has been introduced recently. It has features
different from that of i-gel. AuraGain has an inflatable cuff and a curved body,in addition
because the airway tube of Ambu AuraGain is wide can be used as a conduit for tracheal
intubation[6].
The present study is aimed at comparing the oropharyngeal leak pressure when inflatable
supraglottic device LMA Aura Gain and non-inflatable supraglottic device i- gel is inserted by
the trainee anaesthesiologist.
Aims and objectives
The purpose of this study is to compare the oropharyngeal leak pressure, first attempt success
rate, total insertion attempts, insertion time, oropharyngeal leak pressure, gastric tube insertion,
fiber optic view and complications associated with Inflatable LMA aura gain and non-inflatable
supraglottic airway device i- gel by trainee anaesthesiologist.
Primary outcome:
ï‚· To determine oropharyngeal leak pressure of Non-inflatable SAD I-gel and inflatable
SAD Ambu Aura Gain by trainee Anaesthesiologist.
Secondary outcome:
ï‚· First-time insertion success rate of Non-inflatable LMA i-gel versus inflatable LMA
Ambu Aura Gain by trainee Anaesthesiologist.
ï‚· No. of attempts required for successful placement of SAD
ï‚· Effective device insertion time
ï‚· Fiberoptic grading of SAD placement
ï‚· Ease of insertion of gastric tube
ï‚· Complications- staining of LMA after removal, sore throat
ï‚· Ease of insertion by the trainee
Material and Methods
Study Design and Sample Size
The samples size calculation was based on a previous study [Theiler LG, et al. 2009](22,23)
reporting that the OLP of the i-gel™ was 27±9 cmH2O. Assuming that a difference of 20% in
the OLP was clinically significant, at minimum two-sided 95% confidence interval and at 90%
power of the study, required 60 patients in each group. Finally, a total of 130 patients will be
randomized with 65 patients in group1 and 65 patients in group 2. Sample size was estimated
using software “Power analysis and sample size, version-16 (PASS-16)â€.
Study Setting
Tertiary care hospital in northern India.
Inclusion Criteria
1. ASA I and II patients
2. Both male and female patients between 18-65 years of age
3. Elective procedures(Duration of surgery less than 3 hours)
4. Patient with BMI less than 30 kg/m2
Exclusion Criteria
1. Patients unable (legally incompetent) or unwilling to give consent.
2. ASA III/IV patients
3. Patients with BMI more than 30 kg/m2
4. Patients in whom Supraglottic devices are contraindicated.
5. Patients with neurological or cognitive deficits, anticipated difficult airway.
6. Patients with increased risk of aspiration.
7. Patients with reduced cardiopulmonary reserve.
Material and Method
Following approval from the Institutional Ethics Committee and registering the trial in CTRI
and after obtaining written and informed consent from all-participating patients, a prospective
randomized control study will be conducted to compare non inflatable SAD (supraglottic airway
device) I-gel versus Inflatable SAD LMA Ambu Aura Gain. All trainee anesthesiologists will
be trained with audio, visual and manikin-based skill learning of LMA insertion. Training
Anaesthesiologist will be the one who has joined the Department of Anaesthesiology within 3
years. All trainees will be trained on both the SAD devices, explaining its preparation,
lubrication of the device, insertion technique, fixation, and evaluation of its efficacy. The trainee
will also assist and witness at least 20 LMA insertions in operative room before they participate
in the study. Trainee will be chosen with randomization for the type of LMA insertion during
the study.
During the pre-operative visit, the detailed history will be recorded and clinically examined.
Informed written consent will be obtained from all the patients. On the day of the surgery, the
patient will be kept fasting for 6 hours to solid food and 2 hours to clear liquids prior to entering
the operating room.
The trainee will be randomly categorized into two groups (Group A: Ambu Aura Gain and
Group I: I-gel) by computer-generated random numbers that were enclosed in a sealed envelope
opened only at the time of induction. The sizes of the I-gel and Ambu Aura Gain devices are as
per the manufacturer’s recommendation and are based on the patients’ body weight, i.e., Size 3
for weight 30-60 kg and size 4 for 50-90 kg for the I-gel; and size 3 for weight 30-50 kg, size 4
for 50-70 kg and size 5 for 70-100 kg for the Ambu Aura Gain.
After securing intravenous access, all patients will be monitored using non-invasive blood
pressure, electrocardiogram (ECG), pulse oximeter (SpO2) and capnography. All patients will
be pre-medicated with midazolam 1.5-2 mg and fentanyl 2 µg kg−1. Following pre-oxygenation
with 100% oxygen for 3 minutes, anaesthetic induction will be initiated with i.v propofol 2 mg
kg−1. The head placed in neutral position on a pillow. After the loss of motor response to jaw
thrust LMA will be inserted by the trainee.
A well lubricated Ambu Aura Gain will be inserted by keeping the handle/shaft approximately
parallel to the patient’s chest and then pushing the device along the hard palate after opening the
mouth. Similarly, the I-gel will be introduced using a standard technique in which the device is
firmly grasped, with the cuff outlet facing the chin and then gently guided along the hard palate
until resistance is felt [11,12,17 to 19].
The device will be either reinserted or the size of the device will be changed if an obvious leak
is observed. If the insertion fails even after three attempts, an alternative device will be used and
operator will be changed to consultant and that patient will be excluded from the study.
Insertion time is defined as time needed for insertion of a prepared SAD insertion to its
successful confirmation of effective ventilation with a visible etCO2 tracking on the monitor
and bilateral chest movement. Correct position of SAD will be also be confirmed using
“suprasternal notch†and “bubble†tests. The effective device insertion time starts when the
prepared SAD device is picked up by the operator. Patients will undergo Pressure control
ventilation (PCV mode) with a target tidal volume of 7-8 mL⋅kg−1. Anaesthesia will be
maintained with air + oxygen mixture with sevoflurane and intermittent boluses of fentanyl. All
patients will receive 1 g of injection Paracetamol post induction of anaesthesia as a standard
protocol.
Immediately after insertion, OLP will be determined by closing the adjustable pressure limiting
valve of the breathing circuit, with a fresh gas flow of 3 L/min and the patient head in neutral
position [7,10,14,15,16]. While increasing the airway pressure only up to 40 cmH2O,
oropharyngeal leak was assessed by placing the stethoscope and hearing for noise over the
patient’s neck, immediately lateral to the thyroid cartilage. The OLP will be the pressure in the
circuit when noise is heard and there is equilibrium in the airway pressure in the breathing circuit
[8]. After determination of the OLP, fiberoptic views will be obtained by anesthesiologist by
placement of a fiberoptic scope [21] through the SAD. The fiberoptic scope is passed to a
position just proximal to mask aperture bars and view is scored as follows Brimacombe scoring
:4-Only cords seen;3-Cords plus posterior epiglottis seen ;2-Cords plus anterior epiglottis
seen;1-Cords not seen but function adequate;0-Failure to function where cords not seen fiberoptically. Function is not relevant for scores 4 to 2 because the vocal cords are visible and any
failure to function is not due to proper positioning [22].
After the device has been successfully placed, a lubricated size 10 French G gastric tube will be
inserted. The ease of insertion is graded as easy, difficult and impossible. The patients’ heart
rate (HR), mean arterial blood pressure (MAP), peak airway pressure and SpO2 will be recorded
base line, just after insertion of the LMA and then for every 10-minutes. SpO2<95% is
considered as oxygen desaturation. Following surgery, the device is removed when the patient
becomes awake and responsive. The integrity of the device and the presence of blood stains will
be noted. The patient is inspected for any complications related to LMA insertion like - injury
to the lips, tongue and teeth. On removal of the device cough, staining of LMA and sore throat
and dysphagia (for next 24 hrs) will be recorded.
PATIENT’S PROFORMA
Name:…………………………………………….Age…………Sex………………………
CR No………………………………. Weight..…………Height……………………………….
Diagnosis……………………………………………………………………..............................
Comorbidities………………………………………
Duration of Anaesthesia………………………..
Complications- LMA staining, injury to lips, teeth , sore throat, cough and dysphagia
Oropharyngeal Leak Pressure
No.of SAD’s priorly placed by the trainee
No. of LMA Insertion attempt taken
Attempt no. of successful insertion
LMA insertion time
Duration of surgery
Peak air way pressure
BP and Heart rate
Spo2
Capnongram
Variables AmbuAura Gain i-gel
No.of insertion attempts
ï‚· One
ï‚· Two
ï‚· Three
Oropharyngeal seal leak
pressure(cm of H20)
Ease of gastric tube
insertion
ï‚· Easy
ï‚· Difficult
ï‚· Impossible
Ventilatory parameters
Haemodynamic parameters
Fibreoptic anatomic view
of glottic structures
Brimacombe score
4-Only cords seen
3-Cords plus posterior
epiglottis seen
2-Cords plus anterior
epiglottis seen
1-Cords not seen but
function adequate
0-Failure to function
where cords not seen fiberoptically
Ease of insertion by the
performer
• Easy
• Difficult
Blood stain on the device
Sore throat
Any other side effect
Statistical analysis:
Mean and standard deviation (SD) or median (interquartile range) will be used for continuous
variables depend on normality status. Categorical variables will be presented in number (%).
Two proportion z test / Chi square test / Fisher exact test will be used to compare the
proportions between the groups. Independent samples t test or its non-parametric tests to be
used to compare the means or medians between the study groups. Two-way repeated measures
ANOVA / Linear mixed model to be used to test the association between study groups and
change in the measurements over the time points. All statistical analyses will be performed
using SPSS software for windows version 23.0 (SPSS, Chicago, IL), with a significance level
of 0.05.
Review of literature:
1.Berthold Moser et al conducted a study on oropharyngeal leak pressure of LMA protector
vs the LMA Supreme which demonstrated that LMA Protectorâ„¢ enabled a higher OLP
compared to the LMA Supremeâ„¢.
2.Tomas Henlin et al studied Five different second -generation supraglottic airway devices
ProSeal LMA,Supreme LMA,i-gel,SLIPA, and Laryngeal Tube Suction-D,were
studied.Operators were inexperienced users with a military background,combat
lifesavers,nurses,and physicians.They demonstrated that first attempt success rate was higher
in the Supreme LMA(96%) followed by i-gel (87.9%).Oropharyngeal seal pressures were
higher in the Laryngeal Tube Suction-D and ProSeal LMA groups than in other three devices
3. Hur M et al performed a study on comparison of clinical performance of i-gel with that of
AuraGain in patients with simulated cervical immobilization,which showed the rate of first
attempt successful insertion of i-gel as 92.3% vs 86% for AuraGain. The i-gelâ„¢ and the
AuraGainâ„¢ showed comparable oropharyngeal leak pressures .
4.Myoung H.Kim et al compared the efficacy &safety of the LMA-Supreme and i-gel in
anaesthetised and paralysed elderly patients which demonstrated the rate of successful
insertion at the first attempt was similar between the two groups (94.3 vs. 82.7%, P= 0.072),
more patients required device manipulation during insertion with the LMA-S than the i-gel
(42.3 vs. 18.9%, P=0.011). Good fibreoptic laryngoscopy grades were significantly more
common with the i-gel than the LMA-S (79.3 vs. 55.8%, P=0.042), and peak inspiratory
pressures were lower in the i-gel group both immediately after insertion and at the end of
surgery. Leak pressures were significantly higher in the i-gel group than the LMA-S group,
both immediately after insertion and at the end of surgery (25.8 vs. 23.0, P=0.036; and 28.1
vs. 23.7, P < 0.001 respectively).
5.Jee Eun Chang et al compared the LMA-Protectorâ„¢ and the i-gelâ„¢ in terms of adequacy
of the airway seal, insertion time, ease and accuracy of insertion, and the incidence of
postoperative sore throat,which concluded that The LMA-Protectorâ„¢ provided a better
airway sealing effect than the i-gelâ„¢.
6.Chandra M. Kumar et al suggested replacing routinely practiced ‘blind’ insertion techniques
with a “vision-guided†insertion of SADs which will provide objective evidence of correct
SAD placement in the hypopharynx, adequate inflation of cuff, and correctly chosen SAD
size, with the epiglottis resting on the outside of SAD without downfolding. If these
conditions are met, air leak may be mitigated and airway obstruction avoided; the OLP will
provide a meaningful and scientific proof of the SAD efficacy, paving the way for future
comparative studies of SADs.
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