| CTRI Number |
CTRI/2026/03/105608 [Registered on: 09/03/2026] Trial Registered Prospectively |
| Last Modified On: |
06/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to know the effects of lying on stomach for kidney stone surgery on breathing tube measurements done by ultrasound technique |
|
Scientific Title of Study
|
Effects of the prone position on ultrasonographic airway parameters in adult patients undergoing percutaneous nephrolithotomy under general anaesthesia: A prospective observational study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Swati Chhabra |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences,Jodhpur |
| Address |
Department of Anaesthesiology and Critical Care, D and T block, 3rd floor, All India Institute of Medical Sciences, Basni Phase 2, Jodhpur, Rajasthan
Jodhpur
RAJASTHAN
342005
India |
| Phone |
07340033034 |
| Fax |
|
| Email |
swati_virgo83@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Swati Chhabra |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences,Jodhpur |
| Address |
Department of Anaesthesiology and Critical Care, D and T block, 3rd floor, All India Institute of Medical Sciences, Basni Phase2 , Jodhpur, Rajasthan
Jodhpur
RAJASTHAN
342005
India |
| Phone |
07340033034 |
| Fax |
|
| Email |
swati_virgo83@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Kesava Raj A |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, Jodhpur |
| Address |
Department of Anaesthesiology and Critical care, D and T block,3rd floor,All India Institute of Medical Sciences, Basini Phase2 , Jodhpur, Rajasthan
Jodhpur
RAJASTHAN
342005
India |
| Phone |
09790820763 |
| Fax |
|
| Email |
alagavelkesavaraj@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Basni Phase2, Jodhpur, Rajasthan-342005, India |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Jodhpur |
| Address |
Department of Anaesthesiology and Critical Care, D and T block, 3rd floor, All India Institute of Medical Sciences, Basni Phase 2, Jodhpur, Rajasthan, India-342005 |
| 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 Swati Chhabra |
All India Institute of Medical Sciences, Jodhpur |
Operation theatre, Department of Anaesthesiology and Critical Care, D and T block , 3rd floor, All India Institute of Medical Sciences, Basni Phase2, Jodhpur, Rajasthan, India-342005
Jodhpur
RAJASTHAN |
07340033034
swati_virgo83@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS Jodhpur |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N200||Calculus of kidney, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All adult patients posted for elective percutaneous nephrolithotomy under general anaesthesia in prone position |
|
| ExclusionCriteria |
| Details |
EXCLUSION CRITERIA
History of maxillofacial deformity, tumour, or trauma,
Decompensated heart, respiratory, liver, or kidney diseases,
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the measurements of the anterior soft tissue thickness at the level of the hyoid pre- and post-operatively |
T0 preoperatively
T1 postoperatively (within 30 minutes of extubation) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the measurements of the tongue thickness, tongue volume, and tongue width pre- and post-operatively.
To compare the measurements of the parapharyngeal space pre- and post operatively
To compare the neck circumference measurements pre- and post-operatively
|
T0 preoperatively
T1 postoperatively (within 30 minutes of extubation) |
|
|
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)
|
01/04/2026 |
| 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="1"
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
|
AIMS To compare the preoperative and postoperative ultrasonographic upper airway measurements of patients undergoing percutaneous nephrolithotomy in the prone position. PRIMARY OBJECTIVE To compare the measurements of the anterior soft tissue thickness at the level of the hyoid pre- and post-operatively SECONDARY OBJECTIVES To compare the measurements of the tongue thickness, tongue volume, and tongue width pre- and post-operatively. To compare the measurements of the parapharyngeal space pre- and post operatively To compare the neck circumference measurements pre- and post-operatively INCLUSION CRITERIA All patients aged more than 18 years of age undergoing elective percutaneous nephrolithotomy under general anaesthesia in the prone position EXCLUSION CRITERIA History of maxillofacial deformity, tumour, or trauma, Decompensated heart, respiratory, liver, or kidney diseases, |