RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
BANGALORE, KARNATAKA.
PROFORMA FOR REGISTRATION OF DISSERTATION
TOPIC:
COMPARISION BETWEEN I-GEL AND LARYNGEAL MASK AIRWAY CLASSIC IN PATIENTS UNDER GENERAL ANAESTHESIA WITH
SPONTANEOUS VENTILATION- A RANDOMIZED TRIAL
Dr. MOHAN. H. S
POST GRADUATE
DEPARTMENT OF ANAESTHESIOLOGY
K.V.G MEDICAL COLLEGE AND HOSPITAL
KURUNJIBHAG. SULLIA.-574327
D.K.
KARNATAKA.
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES
KARNATAKA, BANGALORE
ANNEXURE-II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
1.
NAME OF THE CANDIDATE AND
ADDRESS
Dr. MOHAN. H. S
POST GRADUATE STUDENT
DEPARTMENT OF
ANAESTHESIOLOGY K.V.G MEDICAL
COLLEGE AND HOSPITAL
KURUNJIBHAG SULLIA – 574327
2.
NAME OF THE INSTITUTION
K.V.G MEDICAL COLLEGE, SULLIA.
3.
COURSE OF STUDY AND SUBJECT
M.D. ANAESTHESIOLOGY
4.
DATE OF ADMISSION TO COURSE
13-10-2011
5.
TITLE OF TOPIC
COMPARISION BETWEEN I-GEL AND
LARYNGEAL MASK AIRWAY CLASSIC IN PATIENTS UNDER
GENERAL ANAESTHESIA WITH
SPONTANEOUS VENTILATIONA RANDOMIZED TRIAL
COMPARISION BETWEEN I-GEL AND LARYNGEAL MASK AIRWAY CLASSIC IN PATIENTS UNDER GENERAL ANAESTHESIA WITH
SPONTANEOUS VENTILATION-A RANDOMIZED TRIAL.
6
BRIEF RESUME OF THE INTENDED WORK
6.1 Need For the study
The major responsibility of the anaesthesiologist is to provide adequate
ventilation to patient. The most vital element in providing respiration is
maintenance of patent airway. The tracheal intubation is the gold standard method
for maintaining a patent airway during anaesthesia.1
Laryngoscopy and endotracheal intubation produce reflex sympatho-adrenal
stimulation and are associated with raised levels of plasma catecholamines,
hypertension, tachycardia etc.2 Airway devices available can be classified as
intraglottic and extraglottic airway devices, which are employed to protect the
airway both in elective as well as emergency situations.3
The laryngeal mask airway (LMA) has been well established for more than a
decade and is often used when endotracheal intubation was not necessarily
required4. But usage of LMA is limited by the potential risk of aspiration5 or low
pulmonary compliance.6
The i-gel (Intersurgical Ltd, Wokingham, UK) is a new, single-use
supraglottic airway device, for use during anaesthesia. Unlike the conventional
LMAs, it does not have an inflatable cuff. The i-gel is made from a soft, gel-like,
and transparent medical grade
thermoplastic
elastomer.
The cuff has been
designed to create a noninflatable anatomical seal by a shape which is a mirror
impression of the supraglottic anatomy. The i-gel has several other useful design
features including a gastric channel (which allows early recognition of regurgitation
of gastric contents and passage of a drainage tube)7
The main aim of this study is to compare the i-gel with the LMA Classic in
terms of the success of insertion of the device, gas leak pressure, the incidence of
gastric insufflations and postoperative device related complications.
6.2 Review of the Literature:
1. In a study done by Helmy et al where they compared i-gel with classical
LMA, they concluded that there is no statistically significant difference
between both the study groups regarding blood pressure (BP), heart rate
(HR), SpO2, and End tidal CO2 (EtCO2), but insertion and ventilation was
possible at first attempt in 90% patients in i-gel group as compared to 80%
in LMA group.8
2. Richez et al carried out one of the earliest study to evaluate the i-gel. They
found that insertion success rate was 90%, insertion was easy and was
performed at first attempt in every patient.9
3. In a Study done by Keller C, Brimacombe JR et al concluded that for
clinical purposes all four tests are excellent but that the manometric stability
test may be more appropriate for researchers comparing airway sealing
pressure.10
4. In a study done by P. Jindal et al concluded that i-gel effectively conforms to
the perilaryngeal anatomy despite the lack of an inflatable cuff, it
consistently achieves proper positioning for supraglottic ventilation and
causes less hemodynamic changes as compared to other supraglottic
devices.11
5.
In a study done by V uppal et al shows that no significant difference in
efficacy of seal and success rate of first-time insertion between the i-gel
and the LMA Unique although the insertion times for the i-gel are
significantly shorter when compared to the LMA Unique. They concluded
that the i-gel provides a reasonable alternative to the LMA-U for
controlled ventilation during anaesthesia.12
6)
Bimla Sharma et al conducted a randomized prospective comparative study
of proseal LMA versus tracheal tube in laparoscopic cholecystectomy. In
this study success rate of first attempt at insertion was higher for tracheal
tube but not significant (p<0.05). The PLMA group was associated with
better haemodynamic profile (p <0.05) than tracheal tube group.13
7)
Ishwar singh et al studied comparison of clinical performance of i-gel with
LMA proseal in elective surgeries. 60 ASA group I and II adult patients
were randomly assigned into two groups. Group –I (n=30) for i-gel and
group P (n=30) for LMA proseal. The success rate of first attempt of
insertion and ease of gastric tube placement was more with group I (P
>0.05). Blood staining of device and tongue, lip and dental trauma was
more with group P (P > 0.05) and there was no evidence of bronchospasm,
laryngospasm, regurgitation, aspiration or hoarseness in either group.14
8)
P.M. Bodrick et al studied 100 ASA grade I and II spontaneously breathing
patient using LMA in a variety of surgery. Clinically satisfactory airway was
obtained in 98 patients without need to support jaw, extend the head or to handle
the patient in anyway. Insertion was successful in first attempt in 80%, in
second attempt in 70%. In 8 patients the leak was large enough to make
ventilation insufficient, two patients had temporary stridor on removal which
quickly settled, and 12 patients had a temporary sore throat in postoperative
period. 15
9)
Tae-Hyung Han et al studied 1067 ASA I and II patients aged 19-40 years
weighing 34-84 kg undergoing elective caesarean section using LMA.
They concluded that the insertion was successful in 98% at the first
attempt and nine(1%) at the second or third attempt. Air leakage or partial
airway obstruction occurred in 21% patients and 0.7% patients required
intubation. Their study also shows that there were no incidence of
aspiration, regurgitation, laryngospasm, bronchospasm in all insertions of
PLMA.16
10)
Study by N. M. Wharton et al evaluated performance of i-gel supraglottic
airway device in manikins and anaesthetized patients when used by
novices medical students, non anaesthetist physicians and allowed health
professional all unfamiliar with the I-gel. 80% of i-gel was placed in
manikins on first attempt with median insertion time of 14 sec (range 745). 82.5% i-gel were placed in healthy anaesthetized patients and 15% on
the second attempt. Median airway seal was 20cmH2O (13-40) one case of
regurgitation and partial aspiration occurred 17.
6.3 Objectives of the study :
1. To compare the ease of insertion and incidence of gastric insufflations
between i-gel and the LMA-Classic during anaesthesia in spontaneously
breathing patients.
2. To compare haemodynamic changes and postoperative device related
complications between i-gel and the LMA-Classic during anaesthesia in
spontaneously breathing patients.
7
MATERIALS AND METHODS
7.1 Source of data :
The study group will comprise of patients admitted in KVG Medical College
& hospital, Sullia, for various elective surgeries between December 2011 and June
2013.
7.2 Method of Collection of Data :
Inclusion Criteria

Patients aged between 18-60 years

ASA I-II

Body mass index (BMI) between 20-25kg/m2

Scheduled for elective surgeries
Exclusion Criteria

Patients having any abnormality of the neck,

Mouth opening ≤ 2 cm

Upper respiratory tract infections

Intra abdominal surgeries

History of obstructive sleep apnea

Patients who underwent thoracic, abdominal and neurosurgery operations

History of allergy to one or more drugs and latex.

Duration of surgery >2hrs

LMA or i -gel placements had failed after three attempts
Study design, sample size and sampling procedure:
A prospective, randomized, case control study on 100 patients. Patients who
are selected for the study will be randomly allocated to following two groups of 50
each.

Group-A: Patients received anaesthesia with LMA Classic

Group-B: Patients received anaesthesia with I -Gel
Study procedure:
Following approval of the Ethical Committee of KVG Medical College &
Hospital, Sullia and obtaining written informed consent from patients, hundred
patients belonging to ASA I-II, aged between 18-60 years scheduled for elective
surgeries will be enrolled in the study.
Preoperative assessment and medication:
Complete medical history and physical examination will be done for all
patients, including assessment of vital signs and airway assessment. After arrival in
the pre-anaesthetic area, the patients will be given. Inj. Metaclopramide 10 mg. i.v.
1 hr before induction and Inj Glycopyrolate 0.2 mg with inj. midazolam 1.5 mg i,v
just before induction as premedication. After shifting patients inside the operation
theatre, preoxygenated for 3 minutes, and anaesthesia will be induced with propofol
2.5 mg/kg and fentanyl lµg/kg intravenously.
Device insertion:
After an adequate depth of anaesthesia had been achieved, each device will
be inserted by the same senior anaesthetist, In group A, the LMA-Classic will be
inserted according to the manufacturer's instruction manual. A size 3 or 4 LMA
will be used for adult females and a size of 3, 4 or 5 will be used for adult male.
The LMA cuff will be inflated with 20 ml; 30 ml; 40 ml; for size 3; 4; 5;
respectively as recommended by the manufacturer18.
For patients of group B, the I-gel size 3, 4 will be inserted according to the
manufacturer's instructions.9
If it is not possible to insert the device or ventilate through it, two more
attempts of insertion will be allowed. If placements had failed after three
attempts, the case will be abandoned and the airway will be maintained through
other airway device as suitable and this case will be considered as a failed
attempt.
Maintenance of anaesthesia;
After securing the device, spontaneous ventilation in oxygen, nitrous oxide
70 vol% (N2O) and Isoflurane 0.8-1% will be started. Ventilation will be judged to
be optimal if the following four tests will be passed: (i) adequate chest movement;
(ii) stable oxygenation SpO2 not less than 95%; (iii) "square wave" capnography and
(iv) normal range end tidal CO2.
Removal of the device
At the end of the operation, anaesthetic agents will be discontinued, allowing
smooth recovery of consciousness. The device will be removed after the patient regains
consciousness spontaneously and responds to verbal command to open the eyes.
Dysphagia, dysphonia, nausea, vomiting and trauma to mouth, tooth or pharynx and
sore throat will be recorded and will be reassessed within 24 hours.
Parameters measured
Monitoring equipments will be attached to the patient including 5 leads
ECG, non-invasive blood pressure, pulse oximetry. Manometer will be connected
to the proximal end of Magill circuit to measure the airway pressure. The following
parameters will be measured.
1. Heart rate, mean arterial pressure, end-tidal CO2 tension and oxygen saturation
(SpO2) at baseline, after insertion of device, during surgery, at end of surgery
and after removal of device.
2. "The leak pressure by closing the expiratory valve of the Magill circuit at a
fixed low gas flow (3L/min), observing the air-way pressure at which
equilibrium will be reached. At this point gas leakage will be heard at the
mouth, at the epigastrium (epigastric auscultation) or coming out the drainage
tube (I-gel group), manometric stability test is one of the most reliable test.10
3. Number of insertion attempts and each attempt duration (time from picking up
the device until attaching it to the breathing system in seconds).
4. Incidence of airway complications caused by supraglottic devices.

Post-extubation cough, breath holding or laryngospasm,

Presence of blood on the I-gel or LMA

Lip and dental injury.
5. Each patient will be questioned to determine the following complications (in
recovery room and 24 hours postoperatively):

Sore throat (constant pain, independent of swallowing),

Dysphagia (difficulty or pain with swallowing),

Dysphonia (difficulty or pain with speaking),

Numbness of the tongue or the oropharynx,

Blocked or painful ears
Follow- up: Yes
Follow –up- period :24 hours in post-operative ward
Statistical analysis:
The data will be analyzed using SPSS version 11.5 software for windows
7. For categorized parameters chi-square test will be used, Fisher exact test will
be used for data less than 5 in each cell, while for numerical data t-test will be
used to compare two groups. The level of significant used will be p<0.05.
7.3
Does the study require any investigation\intervention to be conducted
on patients\ humans\ animals? If so, please describe briefly:
Yes
This study will be conducted on the 100 patients undergoing surgery under
general anaesthesia with either classic LMA or I–Gel in spontaneous ventilation.
7.4
Has ethical clearance been obtained from your institution in case of
7.3?
Yes. Copy of Ethical Committee Clearance attached.
8
REFERENCES.
1.
The European Resuscitation Council (ERC) and the American Heart
Association (AHA) in collaboration with the International Liaison
Committee on Resuscitation (ILCOR): International Guidelines 2000 for
Cardiopulmonary Resuscitation and Emergency Cardiac Care. An
International Consensus on Science. Resuscitation 2000; 6:29-71.
2. Gal TJ. Airway management. In: Miller RD, editor. Textbook of
anaesthesia, 6th ed. Philadelphia: Elsevier; 2005; 1617-52.
3. Jayashree S. Laryngeal mask airway and its variants. Indian J Anaesth
2005; 49:275-80.
4. Weiler N, Latorre F, Eberle B, Goedecke R, Heinrichs W. Respiratory
mechanics, gastric insufflation pressure, and air leakage of the laryngeal
mask airway. Anesth Analg 1997; 84:1025-28.
5. Barker P, Langton J A, Murphy P J, Rowbotham DJ. Regurgitation of
gastric contents during general anaesthesia using the laryngeal mask
airway. Br J Anaesth 1992; 69:358-60.
6. Asai T, Murao K, Shingu K. Efficacy of the laryngeal tube during
intermittent positive pressure ventilation. Anaesthesia 2000; 55:1099-102.
7. Levitan RM, Kinkle WC. Initial anatomic investigations of the I-gel
airway: A novel supraglottic airway without inflatable cuff. Anaesthesia
2005; 60:1022-66.
8. Amr M Helmy, Hossam M Atef, Ezzat M El-Taher, Ahmed Mosaad
Henidak. Comparative study between I-gel, a new supraglottic airway
device, and classical laryngeal mask airway in anesthetized spontaneously
ventilated patients. Saudi journal of anaesthesia 2010; 4:131-36.
9. Richez B, Saltel L, Banchereau F. A new single use supraglottic device
with a noninflatable cuff and an esophageal vent: An observational study of
the i-gel. Anesth. Analg 2008; 106:1137-39.
10. Keller C, Brimacombe JR, Morris R. Comparison of four methods for
assessing airway sealing pressure with laryngeal mask airway in adult
patients. Br J Anaesth 1999; 82:286-87.
11. Jindal P,Rizvi, A,Sharma JP. Is I-Gel a new revolution among supraglottic
airway devices? A comparative evaluation. Middle East J Anesthesiol
2009; 20:53-58.
12. V Uppal, S Gangaiah, G Fletcher, J Kinsella. Randomised crossover
comparison between the i-gel and the LMA Unique in anaesthetised,
paralysed adult patients. Br J Anaesth 2009; 103(6):882-85.
13. Sharma B, Bhan M, Sinha A, et al. A randomised prospective comparative
study of PLMA versus Tracheal tube in Lap. cholecystectomy. Asian
Archives of Anaesthesiology and resuscitation 2008; 67; 1615-22.
14. Singh I, Gupta M, Tandon M. Comparison of clinical performance of I-gel
with LMA-Proseal in elective surgeries. Indian J of Anaesthesia
2009;53(3):302-305
15. Brodrick PM, Webster NR and Num JF. Use of Laryngeal mask airway in
spontaneously breathing patients in variety of surgery. Anaesthesia. 1989;
72:99-101.
16. Tae-Hyung Han, J.Brimacombe Eun Tu Lee and Long Senk. Using LMA
in elective caesarean section. Indian.Anaesth.2001;58:226-28
17. Wharton NM, Gibbison B, Gabbott DA, et al. I-gel insertion by novices in
manikins and patients. Anaesthesia. 2009; 63(9):991-95
18. Brain A, Denman WT, Goudsouzian NG. Laryngeal Mask North America Inc;
1999. Airway Instruction Manual. San Diego, Calif: LMA North America Inc;
1999;4;131-36
9
10.
SIGNATURE OF CANDIDATE;
REMARKS OF THE GUIDE;
I-gel is a new device, so
camparasion between I-gel and LMA is a
good topic for dissertation
11.
11.1 NAME AND DESIGNATION
OF
11.1 Guide :
Prof. GANAPATHY. P
PROFESSOR AND HEAD OF THE
DEPARTMENT
11.2 Signature :
11.3 Head of the department:
11.4 Signature:
12.
12.1 Remarks of the Principal:
12.2 Signature :
Prof. GANAPATHY. P
ETHICAL COMMITTEE CLEARANCE
1.
TITLE OF DISSERTATION:
COMPARISION
BETWEEN
I-GEL
AND
LARYNGEAL MASK AIRWAY - CLASSIC IN
PATIENTS UNDER GENERAL ANAESTHESIA
WITH
SPONTANEOUS
VENTILATION
- A RANDOMIZED TRIAL
2.
NAME OF THE CANDIDATE:
Dr. MOHAN. H. S
3.
NAME OF THE GUIDE:
Prof. GANAPATHY. P
4.
APPROVED/NOT APPROVED:
APPROVED
Sri. KRISHNAMURTHY, Chairperson.
Dr. SUBBANNAYYA KOTIGADDE, Secretary.
Dr. GOPAL RAO, Member.
Dr. C.S. MOHANRAJ, Member.
Dr. H.R.SHIVAKUMAR. Basic scientist.
LAW EXPERT; Sri. KRISHNAMURTHY. Advocate
5
PRINCIPAL
K.V.G MEDICAL COLLEGE AND HOSPITAL, SULLIA.
COMPARISION BETWEEN I-GEL AND LARYNGEAL MASK AIRWAY - CLASSIC IN
PATIENTS UNDER GENERAL ANAESTHESIA WITH SPONTANEOUS VENTILATION A RANDOMIZED TRIAL
PROFORMA
INFORMED CONSENT
I Dr.MOHAN.H.S.PG Department of anaesthesia conducting a randomized trial for award of
MD degree in Anaesthesia.
The topic of the study is:
COMPARISION BETWEEN I-GEL AND LARYNGEAL MASK AIRWAY -CLASSIC IN
PATIENTS UNDER GENERAL ANAESTHESIA WITH SPONTANEOUS
VENTILATION- A RANDOMIZED TRIAL
Objectives:
1
To compare the ease of insertion and incidence of gastric insufflations between i-gel
and the LMA-Classic during anaesthesia in spontaneously breathing patients.
3. To compare haemodynamic changes and postoperative device related complications
between i-gel and the LMA-Classic during anaesthesia in spontaneously breathing
patients.
I have been briefed on the foregoing research being conducted by
Dr.Mohan.H.S.and it has been conveyed to me in my own language .I have had the
opportunity to ask questions about it & all questions that I have asked have been
answered to my satisfaction.I consent voluntarily to participate as a participant in this
research & understand that I have the right to withdraw from the research at any time
without in any way affecting my medical care.
Name of the
participant:………………………………………………………………………………
Signature of the
participant:………………………………………………………………………………
Date:(d/m/y)……………………………………………………………………………
If illiterate
A literate witness must sign( If possible this person should be selected by the
participant and should have no connection to the research team)
I have read and witnessed the accurate reading of the consent form to the
potential participant and the individual has had the opportunity to ask questions,I
confirm that the individual has given consent freely.
Name of the witness............................................................
Signature of witness:……………….............................…
Date:(d/m/y)……………................................................
Thumb impression of participant
I have read and witnessed the accurate reading of the consent form to the potential
participant and the individual has had the opportunity to ask questions,I confirm that
the individual has given consent freely. In case of any doubt I have been asked to
contact :
Dr.MOHAN.H.S.
PG. ANAESTHESIA
K.V.G.MEDICAL AND HOSPITAL.SULLIA.574327
CONTACT NO: 9964584035
Name of Researcher:………………………………………………………
Signature of researcher:……………………………………………………
Date :( d/m/y)………………………………………………………………
A copy of this informed consent form has been provided to participant
……………………………………….......... after initialed by the Researcher.
PROFORMA
COMPARISION BETWEEN I-GEL AND LARYNGEAL MASK AIRWAY -CLASSIC IN PATIENTS
UNDER GENERAL ANAESTHESIA WITH SPONTANEOUS VENTILATION- A RANDOMIZED TRIAL
Group (Tick any one)
 Group-A: LARYNGEAL MASK AIRWAY – CLASSIC
 Group-B: I-Gel
GENERAL CHARACTERSTIC ;
 Name
:
 Age/Gender
:
 IP. Number
:
 Ward/SU
:
 Date of surgery
:
 ASA Physical status
:
 Co morbidity
:
 Patient on any drugs
:
 Weight
:
 Height
:
 Body mass index
:
 Airway
:

Mouth opening (cms.)

Modified mallampatti grade
 Type of surgery
:
:
:
 Patient position during surgery
:
 Duration of surgery
:
 Monitors
:

SpO2
:

NIBP
:

5 Lead ECG
:

EtCO2
:
Medications : Pre-medication :
Inj. Metaclopramide 10 mg i.v 1 hr before induction
Inj. Midazolam. 1.5 mg i.v just before induction
Inj Glycopyrolate 0.2 mg i.v just before induction
OBSERVATIONS:
Number of insertion attempt (tick any one):
 1
 2
 3
 failure
Duration of insertion attempt in seconds:
Efficacy of seal
o Airway Leak pressure ( cm H2O)- Manometer method :
Gastric Insufflation: ( tick any one );
 Yes
 No
Intraoperative haemodynamics:
TIME
Baseline
Post Induction
1Min. after insertion
5 Min. after insertion
10 Min. after insertion
15 Min. after insertion
20 Min. after insertion
Heart rate
MAP
EtCo2
SpO2
25 Min. after insertion
30 Min. after insertion
45 Min. after insertion
1hr, after insertion
1hr.15 Min. after insertion
1hr 30 Min. after insertion
2hrs. after insertion
After removal of device
MAP-Mean arterial pressure
Spo2 - Oxygen saturation
EtCo2 –End tidal CO2
Post operative device related complications (followed up for 24 hrs postoperatively)
 Presence of blood in airway device
 Yes
 No
 Post extubation cough
 Yes
 No
 Laryngospasm
 Yes
 No
 Sore throat
 Yes
 No
 Dysphagia
 Yes
 No
 Dysphonia
 Yes
 No
 Nausea /Vomiting
 Yes
 No
 Trauma to the lip/ teeth/pharynx
 Yes
 No
 Arrhythmia
 Yes
 No
 Odynaphagia
 Yes
 No
 Ear pain / Blocked ears
 Yes
 No
 Successful Gastric tube insertion
 Yes
 No
 Numbness of tongue
 Yes
 No