RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE, KARNATAKA

ANNEXURE – II

SYNOPSIS FOR REGISTRATION OF SUBJECT FOR DISSERTATION

1. Name of the DR. CHETAN B. BHAT

candidate and P.G. IN ANAESTHESIOLOGY,

Address DEPARTMENT OF ANAESTHESIOLOGY AND

(In Block Letters) CRITICAL CARE,

VIJAYANAGAR INSTITUTE OF MEDICAL

SCIENCES, BELLARY, KARNATAKA,

583104.
2. Name of the
VIJAYANAGAR INSTITUTE OF MEDICAL
Institute
SCIENCES, BELLARY, KARNATAKA.
3. Course of Study M.D. DEGREE IN ANAESTHESIOLOGY

and Subject
4. Date of Admission
17-06-2010
to Course
5. Title of Topic “COMPARISON OF THE LARYNGEAL MASK

AIRWAYS: LMA-CLASSIC AND LMA-PROSEAL IN

CHILDREN.”
6. BRIEF RESUME OF THE INTENDED WORK

6.1 NEED FOR THE STUDY

The Laryngeal Mask Airway (LMA) is a supraglottic airway device

designed to maintain a clear airway, which sits outside of and creates a seal

around the larynx. It is relatively non-invasive as compared to endotracheal

intubation and in scenarios where endotracheal intubation is not mandatory, LMA

has emerged as a formidable choice over endotracheal intubation 1. Compared

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with the face mask, the LMA allows for a more "hands-free approach" to airway

management 2. In difficult airway management, LMA can bypass obstruction at

supraglottic level and allow rescue oxygenation and ventilation, provided that

mouth opening is sufficient 3.

The LMA-Classic is a first generation supraglottic airway device, with

largest evidence base for efficacy and safety, and is considered benchmark against

which newer LMA are judged 1. However, use of positive pressure ventilation and

the associated gastric insufflations are a limitation of its use 4.

The LMA-ProSeal is a second generation supraglottic airway device with

modified cuff and drainage tube, designed for better seal with both the respiratory

and gastrointestinal tracts, notwithstanding the access to the alimentary tract 5, 6, 7.

The present study is planned to compare efficacy of the LMA-Classic and LMA-

ProSeal in children undergoing elective surgery under general anaesthesia.

6.2 REVIEW OF LITERATURE

Brain invented LMA-Classic in 1983, and was introduced into pediatric

anaesthesia practice in 1988. Since then, the LMA-Classic has found widespread
1, 8
acceptance in Pediatric Anesthesia Practice . However, the limitation of the

LMA-Classic for use during the positive pressure ventilation and the associated

gastric insufflations, led to the refinement of the design of the LMA-Classic

leading to invention of the LMA-ProSeal by Brain et al in 2000 6.

In randomized crossover study by K. Goldmann et al, in which thirty

anaesthetized, non-paralyzed children were randomly assessed with size 2 LMA-

ProSeal and LMA-Classic, ease of insertion and quality of initial airway were

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similar for both devices. However, air entry into the stomach occurred more

frequently with the LMA-Classic 9.

Shimbori H. et al randomized sixty children undergoing herniorrhaphy,

orchiopexy or myringotomy to size 2 LMA-Classic or size 2 LMA-ProSeal

groups for airway management. There was no statistical difference between the

two groups for the success rates at first attempt of insertion. However the LMA-

Classic had a higher rate of postoperative blood staining on the device, but there

was no tongue-lip-dental trauma or hoarseness in either group 10.

An Indian study by Pravesh Kanthed et al, found the ease of insertion and

the number of attempts at insertion were comparable between LMA-ProSeal and

LMA-Classic. There was no difference in pharyngolaryngeal morbidity and no

incidence of regurgitation or aspiration between LMA-ProSeal and LMA-Classic.

Also, the LMA-ProSeal offered high reliability of gastric tube placement 7.

K. Goldmann et al, with size 21/2 LMA, in their randomized crossover

study, had similar ease of insertion and first-attempt insertion success rate for

LMA-ProSeal and LMA-Classic. However, The LMA-ProSeal had better quality

of insertion. Air entry into the stomach was more common with the LMA-Classic
4
.

In a randomized, non-crossover study by Lopez-Gil M et al, LMA-ProSeal

and LMA-Classic had similar ease of insertion, fibreoptic position, and frequency

of mucosal trauma. Also, there were no differences in performance among the

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sizes 2, 2.5, and 3 of either LMA-ProSeal or LMA-Classic 5.

6.3 OBJECTIVES OF THE STUDY

Effectiveness of LMA-ProSeal as compared to LMA-Classic in children

regarding a) Ease of insertion and number of insertion attempts; b) Device

positional stability and possible oropharyngeal leak; c) Airway trauma and d)

Hemodynamic changes

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7. MATERIAL AND METHODS

7.1 SOURCE OF DATA

The study will be done in the Vijayanagar Institute of Medical Sciences in

the Department of Anesthesiology and Critical Care for period from 01–Jan –

2011 to 30–Dec–2011.

Inclusion criteria:

a. Pediatric patients of age 3 years and above with weight between 5 kg to

45 kg.

b. American Society of Anesthesiologists Physical Status Grade I or II.

c. Elective surgical procedures in supine position.

Exclusion criteria:

a. Refusal by the parent / guardian for the consent for study.

b. American Society of Anesthesiologists Physical Status III and above.

c. Patient at specific risk of aspiration and anticipated difficult airway.

d. Head and neck procedures.

7.2 METHODS OF COLLECTION OF DATA – (Including sampling

procedure if any)

After taking permission from ethics committee and with parental consent, 60

patients will be enrolled in the study and randomly allocated to one of the two

groups, applying computer generated randomization In Group A (LMA-C group):

LMA-Classic will be inserted, while in Group B (LMA-P group): LMA-ProSeal

will be inserted.

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 7.3 Does the study require any investigation or intervention to be conducted

on patients or other humans or animals? If so please describe briefly?

Yes, the following blood investigations from the peripheral venipuncture

sample are done pre-operatively: Hemoglobin, Blood grouping and Rhesus

typing, Random blood sugar, Blood urea and Serum Creatinine. All procedures

and investigations will be done under the direct supervision of the guide.
7.4 Has ethical clearances been obtained from your institution in case of 7.3

Yes, Ethical clearance has been obtained from the VIMS Institutional Ethics

Committee, Vijayanagar Institute of Medical Sciences.

8. LIST OF REFERENCES

1. Michelle C. White, Tim M. Cook, Peter A. Stoddart. A critique of elective

pediatric supraglottic airway devices. Pediatric Anesthesia 2009 19 (Suppl.

1): 55–65.

2. Efrat R, Kadari A, Katz. The laryngeal mask airway in pediatric anesthesia:

experience with 120 patients undergoing elective groin surgery. J Pediatr

Surg. 1994 Feb;29(2):206-8.

3. Bhavesh Patel, Robert Bingham. Laryngeal mask airway and other

supraglottic airway devices in paediatric practice Contin Educ Anaesth Crit

Care Pain February 1, 2009 9:6-9.

4. Goldmann K, Jakob C. A randomized crossover comparison of the size 2 1/2

laryngeal mask airway ProSeal versus laryngeal mask airway-Classic in

pediatric patients. Anesth Analg. 2005 Jun;100(6):1605-10.

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5. Lopez-Gil M, Brimacombe J, Garcia G. A randomized non-crossover study

comparing the ProSeal and Classic laryngeal mask airway in anaesthetized

children. Br J Anaesth. 2005 Dec;95(6):827-30.

6. Brain AI, Verghese C, Strube PJ. The LMA ProSeal – a laryngeal mask with

an oesophageal vent. Br J Anaesth. 2000 ; 84 (5): 650-4.

7. Kanthed P, Sharma B, Sood J, Kumra VP. Comparison of LMA-ProSeal TM

with LMA ClassicTM in Anaesthetised Paralysed Children. Indian J Anaesth

2008;52:44.

8. Brain AI. The development of the Laryngeal Mask–a brief history of the

invention, early clinical studies and experimental work from which the

Laryngeal Mask evolved. Eur J Anaesthesiol Suppl 1991; 4: 5–17.

9. K. Goldmann, C. Jakob. Size 2 ProSeal™ laryngeal mask airway: a

randomized, crossover investigation with the standard laryngeal mask

airway in paediatric patients. Br J Anaesth. 94(3):385-389.

10. H. Shimbori, K. Ono, T. Miwa, N. Morimura, M. Noguchi, K. Hiroki.

Comparison of the LMA-ProSeal™ and LMA-Classic™ in children. Br J

Anaesth. 93(4): 528-531.

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9. SIGNATURE OF THE
CANDIDATE

10. REMARKS OF THE GUIDE

11. NAME & DESIGNATION (IN

BLOCK LETTERS)
11.1 GUIDE DR. DEVANAND B., MD, DA, DNB.
Professor and Head,
Department of Anaesthesiology and
Critical Care,
Vijayanagar Institute of Medical
Sciences, Bellary, Karnataka
11.2 SIGNATURE

11.3 CO-GUIDE (IF ANY) DR. BALABHASKAR S., DA, DNB.

Associate Professor,
Department of Anaesthesiology and
Critical Care,
Vijayanagar Institute of Medical
Sciences, Bellary, Karnataka
11.4 SIGNATURE

11.5 HEAD OF THE DR. DEVANAND B., MD, DA, DNB.

DEPARTMENT Professor and Head,
Department of Anaesthesiology and
Critical Care,
Vijayanagar Institute of Medical
Sciences, Bellary, Karnataka.

11.6 SIGNATURE

12. 12.1 REMARKS OF THE

CHAIRMAN & PRINCIPAL

12.2 SIGNATURE

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 BELLARY
26-11-2010
FROM
THE PROFESSOR AND HEAD,
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE,
VIJAYANAGAR INSTITUTE OF MEDICAL SCIENCES,
BELLARY, KARNATAKA

TO
THE PRINCIPAL,
VIJAYANAGAR INSTITUTE OF MEDICAL SCIENCES,
BELLARY, KARNATAKA

Through proper channel

Sir,
As per the regulations of the RGUHS for the Dissertation topic, the following
post graduate student in M.D DEGREE IN ANAESTHESIOLOGY has been allotted
the Dissertation topic as follows by the official registration committee of all qualified
and eligible guides of the Department of Anaesthesiology and Critical Care

NAME TOPIC GUIDE

DR. CHETAN B. BHAT “COMPARISON OF THE DR. DEVANAND B., MD, DA, DNB.
P.G., LARYNGEAL MASK PROFESSOR AND HEAD,
DEPARTMENT OF AIRWAYS: LMA- DEPARTMENT OF
ANAESTHESIOLOGY CLASSIC AND LMA- ANAESTHESIOLOGY AND
AND CRITICAL CARE, PROSEAL IN CRITICAL CARE,
VIJAYANAGAR CHILDREN” VIJAYANAGAR INSTITUTE OF
INSTITUTE OF MEDICAL SCIENCES, BELLARY,
MEDICAL SCIENCES, KARNATAKA
BELLARY,
KARNATAKA
Therefore I request you to kindly communicate the acceptance of the dissertation
topic allotted to the P.G student at an early date.

Thanking you
Yours faithfully

(Dr. DEVANAND B., MD, DA, DNB.)

9
 BELLARY
26-11-2010
FROM
THE PROFESSOR AND HEAD,
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE,
VIJAYANAGAR INSTITUTE OF MEDICAL SCIENCES,
BELLARY, KARNATAKA

TO
THE REGISTRAR,
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
BANGALORE, KARNATAKA.

Sir,
Through proper channel

As per the regulations of the RGUHS for the Dissertation topic, the following post
graduate student in M.D DEGREE IN ANAESTHESIOLOGY has been allotted the
Dissertation topic as follows by the official registration committee of all qualified and
eligible guides of the Department of Anaesthesiology

NAME TOPIC GUIDE

DR. CHETAN B. BHAT “COMPARISON OF DR. DEVANAND B., MD,
THE LARYNGEAL DA, DNB.
P.G.,
MASK AIRWAYS:
DEPARTMENT OF LMA-CLASSIC AND PROFESSOR AND HEAD,
LMA-PROSEAL IN DEPARTMENT OF
ANAESTHESIOLOGY
CHILDREN”
AND CRITICAL CARE, ANAESTHESIOLOGY
VIJAYANAGAR AND CRITICAL CARE,
INSTITUTE OF VIJAYANAGAR
MEDICAL SCIENCES, INSTITUTE OF
BELLARY, KARNATAKA MEDICAL SCIENCES,
BELLARY, KARNATAKA.

Therefore I request you to kindly communicate the acceptance of the dissertation

topic allotted to the P.G student at an early date.

Thanking you
Yours faithfully

(Dr. DEVANAND B., MD, DA, DNB.)

10
 Bellary
26-11-2010
FROM
DR. CHETAN B. BHAT,
P.G. IN ANAESTHESIOLOGY,
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE,
VIJAYANAGAR INSTITUTE OF MEDICAL SCIENCES,
BELLARY, KARNATAKA

TO
THE PRINCIPAL,
VIJAYNAGAR INSTITUTE OF MEDICAL SCIENCES,
BELLARY, KARNATAKA

THROUGH PROPER CHANNEL

Respected sir,

Sub: ACCEPTANCE, REGISTRATION AND FORWARDING OF DISSERTATION

TOPIC

In accordance with the above cited topic, I the undersigned studying in P.G course in
M.D DEGREE IN ANAESTHESIOLOGY have been allotted the Dissertation topic
“Comparison of the Laryngeal Mask Airways: LMA-Classic and LMA-ProSeal in
children” under the guidance of Dr. Devanand B., DA, MD, DNB, Professor and
Head, Department of Anesthesiology and Critical Care, Vijayanagar Institute of
Medical Sciences, Bellary, Karnataka. I request you to kindly forward the dissertation
topic in the prescribed form to the University for Approval.

Thanking you
Yours faithfully

(DR. CHETAN B. BHAT)

GUIDE:

DR. DEVANAND B., MD, DA, DNB.

Professor and Head,
Department of Anesthesiology and Critical Care,
Vijayanagar Institute of Medical Sciences,
Bellary, Karnataka.

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