| CTRI Number |
CTRI/2025/10/095524 [Registered on: 01/10/2025] Trial Registered Prospectively |
| Last Modified On: |
30/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To find the association between cuff pressures and postoperative sore throat with the use of second generation supraglottic airway device in short surgeries |
|
Scientific Title of Study
|
An observational study to find the association between the intraoperative cuff pressures and postoperative sore throat with reusable second generation supragllotic airway device in short duration surgeries |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Navita Katoch |
| Designation |
Postgraduate student |
| Affiliation |
Lady Hardinge Medical College |
| Address |
Department of anaesthesia Lady Hardinge Medical College Shahid Bhagat Singh Marg
Central
DELHI
110001
India |
| Phone |
8219494535 |
| Fax |
|
| Email |
katochnavita10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vidhi Chandra |
| Designation |
Professor |
| Affiliation |
Lady Hardinge Medical College |
| Address |
Department of anaesthesia Lady Hardinge Medical College Shahid Bhagat Singh Marg
Central
DELHI
110001
India |
| Phone |
9953204447 |
| Fax |
|
| Email |
drvidhivd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Navita Katoch |
| Designation |
Postgraduate student |
| Affiliation |
Lady Hardinge Medical College |
| Address |
Department of anaesthesia Lady Hardinge Medical College Shahid Bhagat Singh Marg
Central
DELHI
110001
India |
| Phone |
8219494535 |
| Fax |
|
| Email |
katochnavita10@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lady Hardinge Medical College |
|
|
Primary Sponsor
|
| Name |
Lady Hardinge Medical College |
| Address |
Department of anaesthesia Lady Hardinge Medical College Shaheed Bhagat Singh Marg, Delhi pincode-110001 |
| 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 Navita Katoch |
Lady Hardinge Medical College |
Department of anaesthesia, Shaheed Bhagat Singh Marg, New Delhi
Central
DELHI |
8219494535
katochnavita10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee for Human Research, LHMC and Assoc. Hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Age 18 years to 60 years |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
18–60 yr old adult patients with American Society of Anesthesiologists (ASA) Physical Status I–II, undergoing short duration surgeries. |
|
| ExclusionCriteria |
| Details |
1. Patients with upper respiratory tract infection or middle ear infection
2. Any contraindication to supraglottic airway device use
3. Patients with a BMI more than 30 kg per m2 |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of patients developing postoperative sore throat at different intraoperative cuff pressures with reusable second generation supragllottic airway device in patients undergoing short duration surgeries |
Proportion of patients developing postoperative sore throat at baseline, 6 hours, 12 hours, 24 hours and 48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Mean (± SD) OLP achieved
2. Mean POST score
3. Proportion of patients developing other postoperative pharyngolaryngeal complications like dysphagia, dysphonia, post operative nausea & vomiting (PONV). |
assessed at baseline, 6 hours, 12 hours, 24 hours, 48hours |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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)
|
12/10/2025 |
| 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="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
|
There is limited clinical data specifically evaluating the incidence of post-operative sore throatin relation to intraoperative cuff pressures with certain specific reusable second generation supraglottic device. Therefore, this study has been planned. |