| CTRI Number |
CTRI/2024/08/072059 [Registered on: 07/08/2024] Trial Registered Prospectively |
| Last Modified On: |
20/05/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of oropharyngeal leak pressure of Laryngeal mask airway protector,BASKA mask and I Gel in anaesthetized patients for laparoscopic surgery, a prospective randomized study |
|
Scientific Title of Study
|
A prospective, randomized, comparative study of three supraglottic devices -the Laryngeal Mask Airway Protector, the Baska mask and I gel in anesthetized patients for laparoscopic surgery |
| 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 VINISHA RV |
| Designation |
Resident |
| Affiliation |
SRI RAMACHANDRA MEDICAL COLLEGE AND RESEARCH HOSPITAL |
| Address |
Anaesthesiology department,Sri Ramachandra Medical College,Room no-648,Girls hostel,Porur,Sri Ramachandra university Porur,Chennai
Tamilnadu
India
Chennai
TAMIL NADU
600116
India |
| Phone |
8825532225 |
| Fax |
|
| Email |
vinisha8870@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ARUNA PARAMESWARI |
| Designation |
HEAD OF DEPARTMENT |
| Affiliation |
SRI RAMACHANDRAC MEDICAL COLLEGE AND RESEARCH HOSPITAL |
| Address |
Anaesthesiology department
Sri Ramachandra Institute Of Higher Education and Research Porur, CHENNAI
Chennai
TAMIL NADU
600116
India |
| Phone |
9840529863 |
| Fax |
|
| Email |
hod.anaesthesiology@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
DR VINISHA RV |
| Designation |
Resident |
| Affiliation |
SRI RAMACHANDRA MEDICAL COLLEGE AND RESEARCH HOSPITAL |
| Address |
Anaesthesiology department,Sri Ramachandra Medical College,Room no-648,Girls hostel,Porur,Sri Ramachandra university Porur,Chennai
Tamilnadu
India
Chennai
TAMIL NADU
600116
India |
| Phone |
8825532225 |
| Fax |
|
| Email |
vinisha8870@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRI RAMACHANDRA MEDICAL COLLEGE AND RESEARCH HOSPITAL,PORUR,
CHENNAI ,600116 |
|
|
Primary Sponsor
|
| Name |
SRI RAMACHANDRA MEDICAL COLLEGE AND RESEARCH HOSPITAL |
| Address |
Sri Ramachandra University Porur,
Chennai-600116 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 VINISHA RV |
SRI RAMACHANDRA MEDICAL COLLEGE AND RESEARCH HOSPITAL |
OR complex,A6 AND D6 Anaesthesiology Department ,Porur ,Chennai-600116
TAMILNADU
Chennai
TAMIL NADU |
8825532225
vinisha8870@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL RESEARCH ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Laryngeal mask airways |
Comparison between Laryngeal mask airway protector, Baska mask,I Gel |
| Intervention |
Oropharyngeal leak pressure of different Laryngeal mask airways |
Oropharyngeal leak pressure(OLP) will be determined by closing the expiratory valve of the circle system at a fresh gas flow of three litre per minute and observing the airway pressure at equilibrium by auscultating the leak sound over the thyroid cartilage using a stethoscope F for a period of one minute |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients of either gender of ASA(American society of Anaesthesiologists) 1 and 2 for elective Laparoscopic surgery under general anaesthesia |
|
| ExclusionCriteria |
| Details |
Anticipated difficult airway
Lesions in oropharynx
Emergency surgery
Patients at risk of aspiration-hiatus hernia,GI surgeries,GI pathology |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Oropharyngeal leak pressure |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Success insertion at the first attempt
Insertion time
Ease of supraglottic airway insertion
Fibre optic view of vocal cord through the LMA
Ease of gastric tube placement
The presence of blood on the device at the end of removal
Incidence and severity of postoperative sore throat at PACU,12h and at 24hr after surgery |
At baseline,12hrs and 24hrs |
|
|
Target Sample Size
|
Total Sample Size="141"
Sample Size from India="141"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
19/08/2024 |
| 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="1"
Days="1" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| 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 - NO
|
|
Brief Summary
|
The performance of laryngeal mask airway (LMA) as measured by oropharyngeal leak pressure(OLP) is reported to be higher the OLP indicating better seal with patients airway and hence enhanced safety,A high seal pressure guarantees sufficient patient ventilation whenever high peak airway pressures are necessary |