| 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.”
|
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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 |
|
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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 |
|
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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 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 |
|
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Regulatory Clearance Status from DCGI
|
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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 |
|
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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. |