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CTRI Number  CTRI/2024/04/065713 [Registered on: 15/04/2024] Trial Registered Prospectively
Last Modified On: 10/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Change in upper airway related ultrasonographic parameters during percutaneous nephrolithotomy surgery under prone patient position 
Scientific Title of Study   Change in upper airway related ultrasonographic parameters during percutaneous nephrolithotomy under prone position- A prospective observational cohort 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  Darshan GowdaT A 
Designation  Post graduate student 
Affiliation  All India Institute Of Medical Sciences Rishikesh 
Address  Department Of Anaesthesiology, A block, Level 6, AIIMS Rishikesh, Virbhadra road, Rishikesh, Pin code: 249203

Dehradun
UTTARANCHAL
249203
India 
Phone  8105937269  
Fax    
Email  tadarshangowda@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Gaurav Jain 
Designation  Additional Professor 
Affiliation  All India Institute Of Medical Sciences Rishikesh 
Address  Department Of Anaesthesiology, A block, Level 6, AIIMS Rishikesh, Virbhadra road, Rishikesh, Pin code: 249203

Dehradun
UTTARANCHAL
249203
India 
Phone  8808631209  
Fax    
Email  gauravhld@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Gaurav Jain 
Designation  Additional Professor 
Affiliation  All India Institute Of Medical Sciences Rishikesh 
Address  Department Of Anaesthesiology, A block, Level 6, AIIMS Rishikesh, Virbhadra road, Rishikesh, Pin code: 249203

Dehradun
UTTARANCHAL
249203
India 
Phone  8808631209  
Fax    
Email  gauravhld@gmail.com  
 
Source of Monetary or Material Support  
Department Of Anaesthesiology, A block, Level 6, AIIMS Rishikesh, Virbhadra road, Rishikesh, Distt Dehradun, Uttarakhand, India, Pin code 249203 
 
Primary Sponsor  
Name  NONE 
Address  NA 
Type of Sponsor  Other [NA] 
 
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 Darshan Gowda  All India Institute Of Medical Sciences, Rishikesh  Department Of Anaesthesiology, OT complex, B block, Level 6, AIIMS Rishikesh, Virbhadra road, Rishikesh.
Dehradun
UTTARANCHAL 		 8105937269

tadarshangowda@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, AIIMS Rishikesh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  ASA grade 1 and 2
Patients undergoing percutaneous nephrolithotomy surgery under general anaesthesia 
 
ExclusionCriteria 
Details  BMI greater than 35kg/m2
Pregnant women and parturients
Patients with predicted difficult intubation
Patients with abnormal pharynx or anatomy 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the intraoperative change in upper airway related ultrasonographic parameters after anaesthesia induction in patients undergoing percutaneous nephrolithotomy under prone position  Measured at timepoints T2 and T3.
Where, T2- Just after initiation of the mechanical ventilation after confirmation of the endotracheal tube placement
T3- Just after turning the patient to supine position at the end of the surgery  
 
Secondary Outcome  
Outcome  TimePoints 
To correlate the intraoperative duration of proning with change in intraoperative upper airway related ultrasonographic parameters after anaesthesia induction in patients undergoing percutaneous nephrolithotomy under prone position  Measured at timepoints T2, T3 and whole of intraoperative period.
Where, T2- Initiation of the mechanical ventilation after confirmation of the endotracheal tube placement
T3- Shifting of the patient to supine position at the end of the surgery  
To evaluate various factors that may be associated with intraoperative change in upper airway related ultrasonographic parameters after anaesthesia induction in patients undergoing percutaneous nephrolithotomy under prone position.
 		 Whole intraoperative period 
To correlate intraoperative change in upper airway related ultrasonographic parameters with ease of extubation after undergoing percutaneous nephrolithotomy under prone position  Measured at timepoints T2, T3 and during extubation.
Where, T2- Initiation of the mechanical ventilation after confirmation of the endotracheal tube placement
T3- Shifting of the patient to supine position at the end of the surgery  
To correlate intraoperative change in upper airway related ultrasonographic parameters with airway complications during the first 48 hours of postoperative period after percutaneous nephrolithotomy under prone position  Measured at timepoints T2, T3 and for 48 hours postoperatively.
Where, T2- Initiation of the mechanical ventilation after confirmation of the endotracheal tube placement
T3- Shifting of the patient to supine position at the end of the surgery  
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   25/04/2024 
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="1"
Months="0"
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   Surgery under prone position is often a necessity when accessing posterior anatomic structures like spine, retroperitoneum and upper urinary tracts. However, prone position is associated with position related oedema, visual loss, peripheral nerve palsies, pressure sores, cardiovascular compromise, compartment syndrome, oropharyngeal edema, macroglossia, sublingual hematoma which have to be assessed increasingly to be able to predict early and to have adequate prophylactic measures. Ultrasound is a quick, accessible and reliable tool which can be used in operating rooms and can visualize anatomical structures in the supraglottic, glottic and subglottic regions. There is sufficient evidence to advocate utility of airway ultrasound to predict difficult intubation, but literature on intraoperative change in these parameters is sparse. we hypothesize that change in upper airway during prone position may be reflected as significant change in upper airway related ultrasound parameters namely tongue thickness (TT), tongue volume (TV), skin to hyoid distance (SH), skin to thyrohyoid membrane distance (ST). It may help in predicting ease of extubation at the end of surgery and estimating the associated risk of postoperative airway related complications in patient undergoing surgery under prone position. We aim to investigate the intraoperative change in upper airway related ultrasonographic parameters in patients with unanticipated difficult airway, undergoing percutaneous nephrolithotomy under prone position. 
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