| CTRI Number |
CTRI/2025/07/091522 [Registered on: 23/07/2025] Trial Registered Prospectively |
| Last Modified On: |
23/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Application of paratracheal pressure using ultrasound transducer and comparing its effect on supraglottic airway device placement |
|
Scientific Title of Study
|
Comparison of the effects of paratracheal pressure on placement of 2 types of supraglottic airway device - IGEL Vs LARYNGEAL MASK AIRWAY SUPREME a prospective randomised control trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nivedithaa P |
| Designation |
Post graduate |
| Affiliation |
Sri Ramachandra institute of higher education and research |
| Address |
Department of Anaesthesiology and pain medicine, Sri Ramachandra institute of higher education and research, porur
Chennai
TAMIL NADU
600116
India |
| Phone |
9176619070 |
| Fax |
|
| Email |
nivedithaa1121994@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Akilandeswari |
| Designation |
Professor |
| Affiliation |
Sri Ramachandra institute of higher education and research |
| Address |
Department of Anaesthesiology and pain medicine Sri Ramachandra institute of higher education and research porur
Chennai
TAMIL NADU
600116
India |
| Phone |
9840636238 |
| Fax |
|
| Email |
akilaanes@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akilandeswari |
| Designation |
Professor |
| Affiliation |
Sri Ramachandra institute of higher education and research |
| Address |
Department of Anaesthesiology and pain medicine Sri Ramachandra institute of higher education and research porur
TAMIL NADU
600116
India |
| Phone |
9840636238 |
| Fax |
|
| Email |
akilaanes@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH INDIA ,TAMILNADU PORUR CHENNAI - 600116 |
|
|
Primary Sponsor
|
| Name |
Nivedithaa P |
| Address |
Department of Anaesthesiology and pain medicine Sri Ramachandra institute of higher education and research India Tamil Nadu porur Chennai 600116 |
| Type of Sponsor |
Other [Self funding ] |
|
|
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 |
| NIVEDITHAA |
Sri Ramachandra institute of higher education and research |
Department of Anaesthesiology and pain medicine Sri Ramachandra institute of higher education and research
Chennai
TAMIL NADU |
9176619070
nivedithaa1121994@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Sri Ramachandra institute of higher education and research |
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 |
| Intervention |
IGEL |
After induction of general anaesthesia paratracheal pressure shall be applied using ultrasound transducer probe and placement of supraglottic airway device - IGEL shall be attempted and time for successful insertion and resistance will be noted |
| Comparator Agent |
LARYNGEAL MASK AIRWAY SUPREME |
After induction of general anaesthesia paratracheal pressure shall be applied using ultrasound transducer and placement of supraglottic airway device - Laryngeal mask airway supreme shall be attempted and time for successful inset and resistance will be noted |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Scheduled for elective surgery planned under supraglottic airway device as the airway technique |
|
| ExclusionCriteria |
| Details |
Patient refusal
Patient’s at risk of aspiration
Morbidly obese patient’s
Anticipated difficult airway
Patient’s requiring postoperative ventilator support |
|
|
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 required for successful insertion
Number of attempts |
Time required for successful insertion at baseline
Number of attempts at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Resistance during insertion |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108"
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)
|
30/08/2025 |
| 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="1"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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)?
|
|
Brief Summary
|
Supraglottic airway devices play an integral role in airway management in anaesthetic practice. They provide a less invasive and quicker alternative for securing the airway. In patient’s with increased risk of regurgitation and aspiration as a standard technique cricoid pressure is applied to prevent the same. The application of cricoid pressure while inserting a supraglottic airway device poses difficulty in inserting and placement of the device. The application of paratracheal pressure has limited effect on the insertion and placement of the supraglottic airway device. The successful placement of supraglottic airway device after occlusion of oesophagus by applying paratracheal pressure using ultrasound warrants the use of supraglottic airway device in patient’s with risk of regurgitation and aspiration. |