| CTRI Number |
CTRI/2024/06/069558 [Registered on: 26/06/2024] Trial Registered Prospectively |
| Last Modified On: |
26/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of endotracheal tube cuff pressure on sore throat after surgery on patients undergoing keyhole surgeries under general anaesthesia. |
|
Scientific Title of Study
|
Effect Of Cuff Pressure On Postoperative Sore Throat In Laparoscopic Surgeries A Prospective 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 |
Sneha Vaniyan Chandran |
| Designation |
Post Graduate Student |
| Affiliation |
K S Hegde Medical Academy |
| Address |
Department of anaesthesia and ot technology ,K S Hegde Medical Academy P.O. Nityanandanagar, Deralakatte, Mangaluru, Karnataka 575018
Department of anaesthesia and ot technology K S Hegde Medical Academy P.O. Nityanandanagar, Deralakatte, Mangaluru, Karnataka 575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7022775692 |
| Fax |
|
| Email |
snehavaniyan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Govindraj Bhat |
| Designation |
Associate Professor |
| Affiliation |
K s hegde medical academy |
| Address |
Department of Anaesthesiology
Associate professor
K S HEGDE MEDICAL ACADEMY
P.O. Nityanandanagar, Deralakatte, Mangaluru, Karnataka 575018
Associate professor
Department of anaesthesiology
K S HEGDE MEDICAL ACADEMY
P.O. Nityanandanagar, Deralakatte, Mangaluru, Karnataka 575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9343561152 |
| Fax |
|
| Email |
govindrajbhat@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Govindraj Bhat |
| Designation |
Associate Professor |
| Affiliation |
K s hegde medical academy |
| Address |
Associate professor
Department of anaesthesiology
K S HEGDE MEDICAL ACADEMY
P.O. Nityanandanagar, Deralakatte, Mangaluru, Karnataka 575018
Department of anaesthesiology
Associate professor
K S HEGDE MEDICAL ACADEMY
P.O. Nityanandanagar, Deralakatte, Mangaluru, Karnataka 575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9343561152 |
| Fax |
|
| Email |
govindrajbhat@nitte.edu.in |
|
|
Source of Monetary or Material Support
|
| K S Hegde Medical Academy , Derlakatte , Mangaluru 575018
|
|
|
Primary Sponsor
|
| Name |
K S hegde medical academy |
| Address |
K S HEGDE MEDICAL ACADEMY
P.O. Nityanandanagar, Deralakatte, Mangaluru, Karnataka 575018 |
| Type of Sponsor |
Private 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 |
| Sneha Vaniyan Chandran |
Justice K S Hegde Charitable Hospital |
K S Hegde Medical Academy
P.O. Nityanandanagar, Deralakatte, Mangaluru, Karnataka 575018
Dakshina Kannada
KARNATAKA |
7022775692
snehavaniyan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee K S Hegde Medical Academy |
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 |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients belonging to 18-60 years of age undergoing elective laparoscopic surgeries with ASA physical status grade I and II under general anaesthesia |
|
| ExclusionCriteria |
| Details |
Patients with difficult airway
Mallampati grading > III
Pre-existing cough or sore throat
Patients with laryngotracheal abnormalities
Emergency cases
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary objective is to evaluate the occurrence of post operative sore throat after inflating the cuff using a manometer versus the traditional syringe-assisted cuff inflation method |
24 hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| • The secondary objective is to assess the incidence of postoperative hoarseness and cough in the patients. |
24 hour |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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)
|
25/07/2024 |
| 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
|
Tracheal intubation can cause various postoperative complications . One among that is post operative sore throat. In this study we will assess the severity of POST.Post operative sore throat is assessed using Harding and McVey scoring system. The purpose of this study is to evaluate the effect of cuff pressure of endotracheal tube on POST and also to assess the conventional method and instrumental measurement of cuff pressure and its effect on postoperative hoarseness and cough. |