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CTRI Number  CTRI/2025/12/098512 [Registered on: 05/12/2025] Trial Registered Prospectively
Last Modified On: 04/12/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   “Comparing two ways of checking the breathing-tube cuff during surgery — constant pressure monitoring versus the usual manual checking — to see which one leads to fewer sore throat after surgery.”  
Scientific Title of Study   Continuous Endotracheal Cuff Pressure Monitoring vs Conventional Pilot Balloon Palpation Method on incidence of Postoperative Sore Throat (POST) in intubated patients- A Quasi Experimental Controlled Before and After (CBA) Study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  RAJU SHAKYA 
Designation  ASSISTANT PROFESSOR ANAESTHESIOLOGY & CRITICAL CARE 
Affiliation  NEIGRIHMS (North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences) 
Address  FACULTY QUARTER B9E, North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences (NEIGRIHMS), SHILLONG, MEGHALAYA

East Khasi Hills
MEGHALAYA
793018
India 
Phone  9615310805  
Fax    
Email  adarsh204330@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  RAJU SHAKYA 
Designation  ASSISTANT PROFESSOR ANAESTHESIOLOGY & CRITICAL CARE 
Affiliation  North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences 
Address  FACULTY QUARTER B9E, North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences, SHILLONG, MEGHALAYA

East Khasi Hills
MEGHALAYA
793018
India 
Phone  9615310805  
Fax    
Email  adarsh204330@gmail.com  
 
Details of Contact Person
Public Query
 
Name  RAJU SHAKYA 
Designation  ASSISTANT PROFESSOR ANAESTHESIOLOGY & CRITICAL CARE 
Affiliation  North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences (NEIGRIHMS) 
Address  FACULTY QUARTER B9E, North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences (NEIGRIHMS), SHILLONG, MEGHALAYA

East Khasi Hills
MEGHALAYA
793018
India 
Phone  9615310805  
Fax    
Email  adarsh204330@gmail.com  
 
Source of Monetary or Material Support  
North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences(NEIGRIHMS) SHILLONG 
 
Primary Sponsor  
Name  North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences 
Address  NEIGRIHMS, shillong vpo mawdiangdiang east khasi hills district meghalaya 793018 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Raju Shakya  North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences (Neigrihms)  OT Complex 4th floor, dept of anaesthesiology
East Khasi Hills
MEGHALAYA 
9615310805

adarsh204330@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
NEIGRIHMS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z758||Other problems related to medicalfacilities and other health care,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group A  Monitoring of ET cuff pressure to keep it within (20-30) cm H20 
Comparator Agent  Group B  Continuous monitoring of endotracheal cuff pressure. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Adults aged (18–65) years
ASA physical status (I - III) American Society of Anesthesiologists (ASA)classification
Modified Mallampati Grade (I-III)
Expected duration of intubation more than 1 hour
Elective surgery under endotracheal intubation
BMI (19-30) kg per m2 
 
ExclusionCriteria 
Details  More than two attempts of intubation
Patients with preoperative cough, sore throat, smoking, airway disease like COPD
Patients with preoperative nasogastric tube in situ
Previous history of Throat, Laryngeal, or Tracheal Surgery
Pregnancy
Use of nitrous oxide 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate & compare the incidence of postoperative sore throat (POST) within 24 hrs of intubation in patients with continuous cuff pressure monitoring versus the conventional palpation method.  (0, 2, 4, 12 and 24) hour 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate other complications within 24 hours of extubation:
postoperative nausea & vomiting (PONV),
hoarseness
cough. 
(0, 2, 4, 12 and 24) hour 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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 1/ Phase 2 
Date of First Enrollment (India)   22/12/2025 
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="2"
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  

Participants will include patients undergoing elective surgeries requiring general anesthesia with endotracheal intubation. This prospective quasi experimental controlled before and after study will allocate the first 40 patients to Group A and the next 40 patients to Group B, without randomization. Because of the nature of the intervention, the anesthesiologist cannot be blinded, but the outcome assessors and patients will remain blinded to group allocation.

A standardized general anesthesia protocol will be followed for all participants. After fasting as per guidelines and receiving routine premedications, patients will undergo induction with fentanyl, propofol, and rocuronium, followed by endotracheal intubation with a cuffed PVC tube. Cuff inflation techniques will differ between groups. Group A will use pilot balloon palpation based on audible leak, while Group B will have cuff pressure continuously monitored and maintained between 20 to 30 cm H2O at 15 minute intervals. Anesthesia maintenance will include oxygen air mixture with sevoflurane, and muscle relaxation will be maintained with intermittent rocuronium dosing. Sugammadex will be used for reversal at the end of surgery, and postoperative analgesia will include intravenous paracetamol.

Patients requiring more than two intubation attempts will be excluded. Postoperative assessments including sore throat, nausea, vomiting, cough, and hoarseness will be performed at 0, 2, 4, 12, and 24 hours by blinded assessors. Total intubation duration will also be recorded.

 
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