| CTRI Number |
CTRI/2026/01/102080 [Registered on: 27/01/2026] Trial Registered Prospectively |
| Last Modified On: |
27/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
A Study to See How Different Ways of Placing a Breathing Tube During Surgery Affect Throat Pain After Surgery |
|
Scientific Title of Study
|
Effectiveness of Various Endotracheal Cuff Pressure Inflation Strategy on Reducing Post Operative Sore Throat - An Observational 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 |
Sitarama Rao |
| Designation |
PG Scholar |
| Affiliation |
SRM Medical Collage and Research Centre |
| Address |
Room No:D4-23,4th floor, D block Extension, Department of Anesthesia, SRM medical college, SRM Nagar,Potheri, Kattankulathur, Chengalpattu district, Tamil Nadu -603203 India.
Chennai
TAMIL NADU
603202
India |
| Phone |
8667651182 |
| Fax |
|
| Email |
sr0348@srmist.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amirdath Prakash |
| Designation |
Assistant Professor |
| Affiliation |
SRM Medical Collage and Research Centre |
| Address |
Room No:D4-23,4th floor, D block Extension, Department of Anesthesia, SRM medical college, SRM Nagar,Potheri, Kattankulathur, Chengalpattu district, Tamil Nadu -603203 India.
Chennai
TAMIL NADU
603202
India |
| Phone |
9444517870 |
| Fax |
|
| Email |
amirdatr@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amirdath Prakash |
| Designation |
Assistant Professor |
| Affiliation |
SRM Medical Collage and Research Centre |
| Address |
Room No:D4-23,4th floor, D block Extension, Department of Anesthesia, SRM medical college, SRM Nagar,Potheri, Kattankulathur, Chengalpattu district, Tamil Nadu -603203 India.
TAMIL NADU
603202
India |
| Phone |
9444517870 |
| Fax |
|
| Email |
amirdatr@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
| SRM Institute of Science and Technology |
|
|
Primary Sponsor
|
| Name |
SRM Institute of Science and Technology |
| Address |
SRM Medical College Hospital and Research Centre, SRM Nagar, Potheri, Kattankulathur, Chengalpattu, Tamil Nadu, 603203, India. |
| 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 Amirdath Prakash |
SRM Medical Collage Hospital and Research Centre |
Room No:D4-23,4th floor, D block Extension, Department of Anesthesia, SRM medical college, SRM Nagar,Potheri, Kattankulathur, Chengalpattu district, Tamil Nadu -603203 India.
Chennai
TAMIL NADU |
9444517870
amirdatr@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM Medical College Hospital and Research Centre Institutional 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 |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients age group between 18 to 65 years
2.Patients with ASA Physical Status I to III
3.Patients who undergoing elective surgery under general anesthesia with endotracheal intubation
4.Surgery duration between 1 to 3 hours
|
|
| ExclusionCriteria |
| Details |
1.Patients with known airway abnormalities
2.Patients with Pre existing sore throat or upper respiratory infection
3.Patients with anticipated difficult airway
4.Patients who requiring nasogastric tube or throat packing
5.Emergency surgeries |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence and severity of postoperative sore throat in patients undergoing general anaesthesia with endotracheal intubation |
One hour, six hours and twenty four hours after extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of postoperative hoarseness cough and dysphagia in patients undergoing general anaesthesia with endotracheal intubation |
One hour, six hours and twenty four hours after extubation |
|
|
Target Sample Size
|
Total Sample Size="186"
Sample Size from India="186"
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)
|
23/02/2026 |
| 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="0"
Months="6"
Days="0" |
|
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)?
Response - NO
|
|
Brief Summary
|
This is a prospective observational study conducted in adult patients undergoing elective surgery under general anaesthesia with endotracheal intubation. The study aims to evaluate the effect of different endotracheal tube cuff pressure management strategies on the incidence and severity of postoperative sore throat. Patients are observed in multiple groups based on the cuff pressure maintained during surgery. Cuff pressure is measured and maintained using a handheld manometer throughout the intraoperative period. Postoperative sore throat and other airway related complications such as hoarseness cough and dysphagia are assessed after extubation. Outcome assessment is done at one hour six hours and twenty four hours following extubation. The findings of this study are expected to help in identifying optimal cuff pressure management strategies to reduce postoperative airway discomfort and improve patient comfort after general anaesthesia. |