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CTRI Number  CTRI/2024/11/076236 [Registered on: 04/11/2024] Trial Registered Prospectively
Last Modified On: 14/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study to compare three different techniques for insertion of Proseal laryngeal mask airway during anaesthesia to determine the easiest method of insertion  
Scientific Title of Study   Comparison of three different techniques for the insertion of proseal laryngeal mask airway in adults- A prospective randomised clinical study  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr PRATYUSHA 
Designation  POST GRADUATE STUDENT  
Affiliation  Shimoga institute of medical sciences  
Address  DEPARTMENT OF ANAESTHESIOLOGY MAJOR OT COMPLEX, 3RD FLOOR, MCGANN TEACHING DISTRICT HOSPITAL, SHIMOGA INSTITUTE OF MEDICAL SCIENCES

Shimoga
KARNATAKA
577201
India 
Phone  7829653553  
Fax    
Email  pratyushachowdhary777@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr ASHWINI S 
Designation  ASSOCIATE PROFESSOR 
Affiliation  RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES  
Address  MAIN OT COMPLEX, 3rd FLOOR, DEPARTMENT OF ANAESTHESIOLOGY MCGANN TEACHING DISTRICT HOSPITAL, SHIMOGA

Shimoga
KARNATAKA
577201
India 
Phone  9980812398  
Fax    
Email  ashwinisatrasala@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR ASHWINI S 
Designation  ASSOCIATE PROFESSOR  
Affiliation  Shimoga institute of medical sciences  
Address  MAJOR OT COMPLEX, 3RD FLOOR, DEPARTMENT OF ANESTHESIOLOGY, MCGANN TEACHING DISTRICT HOSPITAL, SHIMOGA INSTITUTE OF MEDICAL SCIENCES

Shimoga
KARNATAKA
577201
India 
Phone  9980812398  
Fax    
Email  ashwinisatrasala@gmail.com  
 
Source of Monetary or Material Support  
MCGANN TEACHING DISTRICT HOSPITAL, SHIMOGA INSTITUTE OF MEDICAL SCIENCES,SHIMOGA, KARNATAKA,INDIA-577201 
 
Primary Sponsor  
Name  SHIMOGA INSTITUTE OF MEDICAL SCIENCES SHIMOGA  
Address  DEPARTMENT OF ANESTHESIOLOGY MAJOR OT COMPLEX 3RD FLOOR MCGANN TEACHING DISTRICT HOSPITAL SHIMOGA INSTITUTE OF MEDICAL SCIENCES  
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR PRATYUSHA   McGann Teaching District hospital, Shimoga   DEPARTMENT OF ANESTHESIOLOGY, MAJOR OT COMPLEX, 3RD FLOOR, MCGANN TEACHING DISTRICT HOSPITAL, SHIMOGA INSTITUTE OF MEDICAL SCIENCES
Shimoga
KARNATAKA 
7829653553

pratyushachowdhary777@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, SIMS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L988||Other specified disorders of the skin and subcutaneous tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Insertion of Proseal laryngeal mask airway   Insertion of Proseal laryngeal mask airway using index finger technique  
Comparator Agent  Insertion of Proseal laryngeal mask airway using 90 degree rotation technique   Rotating the Proseal laryngeal mask airway 90 degree clockwise in the oral cavity and rotating it back after reaching the hypopharynx 
Comparator Agent  Insertion of Proseal laryngeal mask airway using metallic introducer  Inserting premounted Proseal laryngeal mask airway using metallic introducer  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients undergoing elective surgeries that require general anaesthesia with Proseal Laryngeal mask airway

2.Age group of more than 18 years and less than 60 years of either sex

3.American society of anaesthesiologists (ASA) physical status 1 and 2

 
 
ExclusionCriteria 
Details  1. Age group of less than 18 years old and more than 60 years old of either sex

2. American society of anaesthesiologists (ASA) physical status 3 and 4 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Time taken for successful insertion of Proseal laryngeal mask airway   From Picking up the Proseal laryngeal mask for insertion till adequate chest rise and ETCO2 graph 
 
Secondary Outcome  
Outcome  TimePoints 
Hemodynamic changes during insertion of Proseal laryngeal mask airway with three different techniques   1)Basal vitals before insertion of Proseal laryngeal mask airway
2) immediately after insertion of Proseal laryngeal mask airway

3) 5 mins after insertion of Proseal laryngeal mask airway
 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/11/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  20/11/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [pratyushakalagara@gmail.com].

  6. For how long will this data be available start date provided 11-07-2024 and end date provided 11-07-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Need for the study:
The Proseal Laryngeal mask airway (PLMA) is a supraglottic airway device
commonly used in clinical practice for airway management during general anaesthesia.
It has been popular due to its ease of insertion, high success rate of insertion, and less
risk of invasive manipulation.
1
However, despite its widespread use, the standard technique for insertion of
Proseal LMA (PLMA) remains a topic of debate. The traditional insertion technique
involves the use of the index finger to place the PLMA into position, which can be
challenging in patients with limited mouth opening, large tongue, or short neck.
2
In
response to these challenges, various alternative techniques have been introduced,
including the 90° rotation technique and the use of metallic introducer.
3
The index finger technique involves using the index finger for introducing the
PLMA upto hypopharynx, allowing for better control and a smoother insertion.
4
The 90 degree rotation technique involves rotating the Proseal laryngeal mask
airway 90 degrees anticlockwise during insertion into oropharynx, which has been
shown to reduce the risk of epiglottic entrapment and improve the seal of the Proseal
LMA.
5
The metallic introducer technique is performed using a rigid metallic introducer
which guides the PLMA into position, which may be advantageous in patients with
difficult airway.
6
However, the insertion technique for the Proseal LMA is crucial for its successful
use, and there is currently no consensus on the most optimal technique. This has led to
the development of different techniques for Proseal LMA insertion, each with its own
advantages and disadvantages. Therefore, our study is proposed to compare the efficacy
of these three techniques and determine the most suitable approach for Proseal LMA insertion 
 
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