| CTRI Number |
CTRI/2025/07/092068 [Registered on: 31/07/2025] Trial Registered Prospectively |
| Last Modified On: |
30/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluating the changes in tracheal cuff pressure in patients undergoing percutaneous nephrolithotomy procedure under general anesthesia in prone position and to correlate it with postoperative sore throat |
|
Scientific Title of Study
|
Evaluation of changes in tracheal cuff pressure in patients undergoing percutaneois nephrolithotomy in prone position and its correlation with sore throat 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 |
Om vasavi palam |
| Designation |
SENIOR RESIDENT |
| Affiliation |
Nizams institute of medical sciences |
| Address |
Nizams institute of medical sciences Panjagutta hyderabad
Hyderabad
TELANGANA
500082
India |
| Phone |
8332922102 |
| Fax |
|
| Email |
omvasavi.palam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sapna Nikhar |
| Designation |
Additional professor |
| Affiliation |
Nizams institute of medical sciences |
| Address |
Nizams institute of medical sciences Panjagutta hyderabad
Hyderabad
TELANGANA
500082
India |
| Phone |
9030460262 |
| Fax |
|
| Email |
sapnanikhar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Om vasavi palam |
| Designation |
SENIOR RESIDENT |
| Affiliation |
Nizams institute of medical sciences |
| Address |
Nizams institute of medical sciences Panjagutta hyderabad
Hyderabad
TELANGANA
500082
India |
| Phone |
8332922102 |
| Fax |
|
| Email |
omvasavi.palam@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nizam’s institute of medical sciences, hyderabad |
|
|
Primary Sponsor
|
| Name |
Om vasavi palam |
| Address |
Nizam’s institute of medical sciences, hyderabad ,500082 |
| Type of Sponsor |
Other [SELF] |
|
|
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 |
| Om vasavi palam |
NIMS |
Department of anesthesiology , NIMS , hyderabad, 500082
Hyderabad
TELANGANA |
8332922102
omvasavi.palam@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Nizam’s institute of medical sciences |
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 |
Cuff pressure manometer( AG Cufill Manometer) |
Assessing tracheal cuff pressure after intubation in supine position, thereafter in prone position at 1st hour of surgery and then at the end of surgery in prone position, and then 4th measurement is done after supining the patient before extubation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Written valid consent, Elective percutaneous nephrolithotomy surgery, Mallampati score 1-3, BMI 18.5-35kg/m2, creatinine less than or equal to 2mg/dl, ASA 1 and 2 |
|
| ExclusionCriteria |
| Details |
1. Patient refusal, Patients with morbid obesity, Anticipated difficult airway, Compromised cardio-respiratory functions, Patient with tracheostomy, Patients with sorethroat, hoarsness, cough, Pregnant women, Procedures requiring transfusion of blood or blood products |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the effect of prone position on tracheal cuff pressure in percutaneous nephrolithotomy surgery |
Assessing tracheal cuff pressure after intubation in supine position, thereafter in prone position at 1st hour of surgery and then at the end of surgery in prone position, and then 4th measurement is done after supining the patient before extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the incidence of postoperative sore throat in prone position in percutaneous nephrolithotomy surgery |
1 year |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
17/08/2025 |
| 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)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This is a Prospective Observational study to evaluate changes in tracheal cuff pressure in patients undergoing percutaneous nephrolithotomy in prone position and its correlation with sore throat
Primary objective- To assess the effect of prone position on tracheal cuff pressure in percutaneous nephrolithotomy surgery Secondary objective– To assess the incidence of postoperative sore throat in prone position in percutaneous nephrolithotomy surgery
Principle goal of tracheal cuff is to maintain and adequate seal in the airway to deliver mechanical ventilation. A cuff pressure between 20-30cm H2O is recommended to provide adequate seal. The ultimate goal is to reduce the risk of complication of over inflation of cuff like post-operative sore throat, hoarseness, cough and under inflation like micro aspiration , ventilator associated pneumonia.
HYPOTHESIS – Tracheal cuff pressure will increase in prone position in percutaneous nephrolithotomy patients and will lead to more incidence of sore throat. |