| CTRI Number |
CTRI/2026/01/101368 [Registered on: 16/01/2026] Trial Registered Prospectively |
| Last Modified On: |
16/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluating The Role Of Internal Jugular Vein Collapsibility Index (IJVCI) In Supine And In Head Up Position For Predicting Post Spinal Hypotension In Elderly Patients Posted For Lower Limb Surgeries |
|
Scientific Title of Study
|
To Evaluate The Role Of Internal Jugular Vein Collapsibility Index (IJVCI) In Supine And In Head Up Position For Predicting Post Spinal Hypotension In Geriatric Patients Posted For Lower Limb Surgeries |
| 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 Nandini C V |
| Designation |
Associate Professor |
| Affiliation |
Dr B R Ambedkar Medical College and Hospital |
| Address |
Department of Anaesthesiology, Dr B R Ambedkar Medical College and Hospital, Kadugondanahalli,
Bangalore
Bangalore KARNATAKA 560045 India |
| Phone |
9535024072 |
| Fax |
|
| Email |
nandinivraj@yahoo.co.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Nandini C V |
| Designation |
Associate Professor |
| Affiliation |
Dr B R Ambedkar Medical College and Hospital |
| Address |
Department of Anaesthesiology, Dr B R Ambedkar Medical College and Hospital, Kadugondanahalli,
Bangalore
Bangalore KARNATAKA 560045 India |
| Phone |
9535024072 |
| Fax |
|
| Email |
nandinivraj@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Nandini C V |
| Designation |
Associate Professor |
| Affiliation |
Dr B R Ambedkar Medical College and Hospital |
| Address |
Department of Anaesthesiology, Dr B R Ambedkar Medical College and Hospital, Kadugondanahalli,
Bangalore
Bangalore KARNATAKA 560045 India |
| Phone |
9535024072 |
| Fax |
|
| Email |
nandinivraj@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Dr B R Ambedkar Medical College and Hospital, Kadugondanahalli, Bangalore 560045, Karnataka , India |
|
|
Primary Sponsor
|
| Name |
Dr Nandini C V |
| Address |
Department of Anaesthesiology, Dr B R Ambedkar Medical College and Hospital, Kadugondanahalli, Bangalore 560045, Karnataka, India |
| 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 |
| Dr Nandini C V |
Dr B R Ambedkar Hospital |
Department Of Anaesthesiology, Major OT complex, 3rd floor Bangalore KARNATAKA |
9535024072
nandinivraj@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution Ethics Committee, Dr B R Ambedkar Medical College |
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 |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients posted for elective lower limb surgery belonging to ASA I, II, III |
|
| ExclusionCriteria |
| Details |
Patients with known coagulation or bleeding disorder
Patient with raised intracranial pressure
Patients with local site infection
Patients with spine deformity |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine whether the internal jugular vein collapsibility index (IJVCI) measured in supine and thirty degree head up preoperatively using ultrasonography can predict the development of post spinal hypotension in geriatric patients undergoing lower limb surgeries under spinal anaesthesia |
Baseline, 15mins Before Subarachnoid Block |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare IJVCI values between geriatric patients who develop post spinal hypotension & those who do not |
Baseline, Before Subarachnoid block, After subarachnoid block, 5min after, 10mins, 15mins, 20mins, 25minutes, 30minutes |
| To identify optimal IJVCI cutoff value that best predicts post spinal hypotension in this population |
Baseline, Before Subarachnoid block, After subarachnoid block, 5min after, 10mins, 15mins, 20mins, 25minutes, 30minutes |
| To examine the relationship between baseline hemodynamic parameters (SBP, DBP, MAP, HR) & development of post spinal hypotension |
Baseline, Before Subarachnoid block, After subarachnoid block, 5min after, 10mins, 15mins, 20mins, 25minutes, 30minutes |
|
|
Target Sample Size
|
Total Sample Size="54" Sample Size from India="54"
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)
|
30/01/2026 |
| 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
|
Spinal anesthesia is widely used for a variety of surgical procedures because of its simplicity, rapid onset, and favorable safety profile. Advantages also include nil airway manipulation, avoidance of polypharmacy, minimizing blood loss and minimal interference with cognition in the perioperative period.
Despite these advantages, post-spinal hypotension remains one of its most frequent and clinically significant complications. This drop in blood pressure occurs as a result of sympathetic blockade, leading to vasodilation and a relative reduction in circulating blood volume. In vulnerable groups—such as elderly patients, individuals with chronic illnesses, or those with limited physiological reserve—this hemodynamic instability can result in organ hypoperfusion, postoperative morbidity, prolonged hospitalization, and increased mortality.
Traditional methods for assessing intravascular volume, including invasive monitoring or ultrasound assessment of the inferior vena cava, may be difficult to apply in all surgical settings due to limitations such as technical difficulty, patient body habitus, and the need for specialized equipment.
The internal jugular vein (IJV), located superficially in the neck, easily visualised offers a more accessible window for ultrasonographic evaluation. Its collapsibility during respiration has been shown to correlate with intravascular volume status. Hence assessing the IJV collapsibility index may serve as a practical and rapid method to estimate a patient’s volume status before spinal anesthesia.
Hence the aim of this study is to determine whether the internal jugular vein collapsibility index (IJVCI), measured through ultrasonography in supine and 30 degree head-up position, can reliably predict the occurrence of post-spinal hypotension in geriatric patients undergoing surgery under spinal anesthesia. By evaluating the relationship between pre-anesthetic IJV measurements and subsequent blood pressure changes, the study seeks to assess whether this noninvasive method can serve as an effective tool for identifying patients at increased risk of hemodynamic instability. |