| 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
|
|
|
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 |
|
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Regulatory Clearance Status from DCGI
|
|
|
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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- 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 - Proposals should be directed to [pratyushakalagara@gmail.com].
- 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.
- 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 |