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CTRI Number  CTRI/2024/08/071816 [Registered on: 02/08/2024] Trial Registered Prospectively
Last Modified On: 27/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Prediction of hypotension by Ultrasound assessment of major veins in elderly patients posted for lower limb orthopedic surgeries.  
Scientific Title of Study   Comparison of the efficacy of inferior vena cava and internal jugular vein collapsibility index in prediction of hypotension in geriatric patient undergoing spinal anaesthesia for lower limb orthopaedic surgery; 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  Dr Garima karamchandani 
Designation  PG resident 
Affiliation  Dr SNMedical college jodhpur 
Address  Orthopedics operation theatre first floor Department Of Anesthesia MDM Hospital Dr SN Medical College Jodhpur
Orthopedics operation theatre first floor Department Of Anesthesia MDM Hospital Dr SN Medical College Jodhpur
Jodhpur
RAJASTHAN
342001
India 
Phone  9588986212  
Fax    
Email  nicks31894@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vikas Rajpurohit 
Designation  Professor 
Affiliation  Dr SNMedical college jodhpur 
Address  Orthopedics operation theatre first floor Department Of Anesthesia MDM Hospital Dr SN Medical College Jodhpur
Orthopedics operation theatre first floor Department Of Anesthesia MDM Hospital Dr SN Medical College Jodhpur
Jodhpur
RAJASTHAN
342001
India 
Phone  9928060011  
Fax    
Email  drvikasrajpurohit@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Garima karamchandani 
Designation  PG resident 
Affiliation  Dr SNMedical college jodhpur 
Address  Orthopedics operation theatre first floor Department Of Anesthesia MDM Hospital Dr SN Medical College Jodhpur
Orthopedics operation theatre first floor Department Of Anesthesia MDM Hospital Dr SN Medical College Jodhpur
Jodhpur
RAJASTHAN
342001
India 
Phone  9588986212  
Fax    
Email  nicks31894@gmail.com  
 
Source of Monetary or Material Support  
Orthopedics Operation Theatre First Floor MDM Hospital Dr SN Medical College Jodhpur 342001  
 
Primary Sponsor  
Name  Orthopedics Operation Theatre First Floor MDM Hospital Dr SN Medical College Jodhpur 342001 
Address  Orthopedics Operation Theatre First Floor MDM Hospital Dr SN Medical College Shastri Nagar Jodhpur 342001 
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 Garima Karamchandani  MDM Hospital Jodhpur  Orthopedics Operation Theatre First Floor MDM Hospital Dr SN Medical College Jodhpur 342001
Jodhpur
RAJASTHAN 		 9588986212

nicks31894@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, Dr SN Medical College , jodhpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M218||Other specified acquired deformities of limbs,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  65.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  Patients aged 65-85 years of either genders.
ASA grade of I or II.
Patient undergoing spinal anesthesia for an elective lower limb orthopedic surgery.
 
 
ExclusionCriteria 
Details  1)Consent refusal by the patient for study
2)Infection at the site of spinal injection
3)Patients with severe hypovolemia or haemorrhagic shock
4)Pre-existing severe neurological, cardiac, renal or liver disease
5) Thrombocytopenia and Coagulopathies
6) Patient currently taking anti-coagulant/anti-platelet therapy.
7) Spine injury
8) Any contraindication of spinal anesthesia.
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
determine the co-relation of IVCCI vs. IJVCI with hypotension after spinal anesthesia in elderly patient undergoing lower limb orthopedic surgery.   30 minutes post spinal anesthesia 
 
Secondary Outcome  
Outcome  TimePoints 
To determine the co-relation between IJVCI and IVCCI with gender and height
 		 30 minutes post spinal anesthesia  
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   10/09/2024 
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="0"
Months="3"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [nicks31894@gmail.com].

  6. For how long will this data be available start date provided 22-12-2024 and end date provided 22-12-2029?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   The study is a prospective observational study which will be conducted at MDM Hospital (Dr.S.N.Medical college jodhpur and attached group of hospitals). The study is meant to evaluate diagnostic accuracy of IJVCI vs IVCCI  and determine the co-relation of both indices with hypotension in elderly patients undergoing lower limb orthopaedic surgery for 30 minutes post spinal anaesthesia. 
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