| CTRI Number |
CTRI/2026/01/101456 [Registered on: 19/01/2026] Trial Registered Prospectively |
| Last Modified On: |
17/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study comparing two airway devices to improve correct placement and stability during anesthesia for elective surgery patients. |
|
Scientific Title of Study
|
Utilization of a Novel Video-Integrated Laryngeal Mask Airway vs conventional LMA for Accurate Placement and Maintenance in Patients Undergoing Elective Surgeries Under General Anesthesia.
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sriram S |
| Designation |
Post graduate |
| Affiliation |
Saveetha medical college and institute |
| Address |
104 main road manganampattu anaikkranchathiram post , thirumailad
Nagapattinam
TAMIL NADU
609102
India |
| Phone |
8098161083 |
| Fax |
|
| Email |
Sapprowsri@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Lakshmi R |
| Designation |
Professor MD anaesthesiology |
| Affiliation |
Saveetha institute of medical and technical sciences |
| Address |
Department of Anaesthesiology,Saveetha medical college and hospital,Saveetha nagar,Chennai Tamilnadu 602105
Saveetha nagar,thandalam, Chennai,Tamilnadu 602105
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
9380535766 |
| Fax |
|
| Email |
rajlakshmidrkr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Lakshmi R |
| Designation |
Professor MD anaesthesiology |
| Affiliation |
Saveetha institute of medical and technical sciences |
| Address |
Department of Anaesthesiology,Saveetha medical college and hospital,Saveetha nagar,Chennai Tamilnadu 602105
Saveetha nagar,thandalam, Chennai,Tamilnadu 602105
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
9380535766 |
| Fax |
|
| Email |
rajlakshmidrkr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha institute of medical and technical sciences , Saveetha nagar , thandalam , Chennai 602105 india |
|
|
Primary Sponsor
|
| Name |
Saveetha institute of medical and technical sciences |
| Address |
Department of anaesthesiology, Saveetha medical college and hospitals,thandalam,Chennai,602105 |
| 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 |
| Sriram s |
Saveetha medical college and hospitals |
Department of anaesthesiology,Saveetha medical college and hospital,thandalam Chennai,602105
Kancheepuram
TAMIL NADU |
8098161083
Sapprowsri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha medical college and hospital institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 2||Placement, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Utilization of a conventional Laryngeal mask airway for Accurate Placement and Maintenance in Patients Undergoing Elective Surgeries Under General Anesthesia.
|
Patients will be premedicated with Inj. Glycopyrrolate 0.01 mg/kg, Inj. Midazolam 0.05 mg/kg, and Inj. Fentanyl 2 mcg/kg intravenously prior to induction. Induction of anesthesia will be achieved with Inj. Propofol 2 mg/kg. Following induction, a conventional laryngeal mask airway will be inserted once per patient via the oral route by the investigating anesthesiologist using the standard blind insertion technique. Correct placement will be confirmed using clinical parameters including chest expansion and capnography. The device will be maintained throughout the surgical procedure and removed at the end of anesthesia. |
| Intervention |
Utilization of a novel video integrated Laryngeal mask airway for Accurate Placement and Maintenance in Patients Undergoing Elective Surgeries Under General Anesthesia. |
Patients will be premedicated with Inj. Glycopyrrolate 0.01 mg/kg, Inj. Midazolam 0.05 mg/kg, and Inj. Fentanyl 2 mcg/kg intravenously prior to induction. Induction of anesthesia will be achieved with Inj. Propofol 2 mg/kg. Following induction, a video-integrated laryngeal mask airway will be inserted once per patient via the oral route by the investigating anesthesiologist under real-time video guidance to ensure accurate placement. The device will be maintained throughout the surgical procedure and removed at the end of anesthesia. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1, 2 patient
Anticipated difficult airway
Lemon score 3 and 4
Elective surgeries
|
|
| ExclusionCriteria |
| Details |
Patient refusal
Lemon score more than 4
Obesity more than 35kg per m2
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the efficacy and accuracy of video integrated versus Conventional Laryngeal mask airway patient undergoing elective surgeries undergoing general anesthesia
|
Timing will be recorded from introduction of the laryngeal mask airway into the oral cavity until confirmation of correct placement by chest expansion and continuous endtidal carbon dioxide tracing. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the number of attempts & repositioning required for intubating with both techniques
To evaluate the time required for intubating with both techniques
|
Timing will be recorded from introduction of the laryngeal mask airway into the oral cavity until confirmation of correct placement by chest expansion & continuous endtidal carbon dioxide tracing. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
29/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
This study compares a novel video integrated laryngeal mask airway with a conventional laryngeal mask airway for accurate placement and maintenance during elective surgeries under general Anaesthesia. The study evaluates placement accuracy insertion success airway stability ventilation parameters and airway related compilations to determine whether video guidance improves supraglottic airway management |