| CTRI Number |
CTRI/2026/04/107263 [Registered on: 01/04/2026] Trial Registered Prospectively |
| Last Modified On: |
30/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
prospective |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study to correlate non-invasive Carotid artery ultrasound with fluid responsive index (Pulse Pressure Variation) to guide fluid management during prone position spine surgery |
|
Scientific Title of Study
|
Correlation of non-invasive carotid doppler indices with pulse pressure variability based goal-directed hemodynamic therapy in prone-position thoracolumbar and lumbar neurosurgical procedures: 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 |
SUNIL JOE JACOB |
| Designation |
SENIOR RESIDENT, DM NEUROANESTHESIA |
| Affiliation |
Govind Ballabh Pant Institute of Postgraduate Medical Education and Research |
| Address |
NEUROANESTHESIA AND CRITICAL CARE,
DEPARTMENT OF ANESTHESIOLOGY AND INTENSIVE CARE, 6TH FLOOR
ACADEMIC BLOCK, GB PANT HOSPITAL, NEW DELHI
New Delhi DELHI 110002 India |
| Phone |
9496290441 |
| Fax |
|
| Email |
drsuniljoejacob@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr KIRAN LATA KIRO |
| Designation |
PROFESSOR |
| Affiliation |
Govind Ballabh Pant Institute of Postgraduate Medical Education and Research |
| Address |
NEUROANESTHESIA AND CRITICAL CARE,
DEPARTMENT OF ANESTHESIOLOGY AND INTENSIVE CARE, 6TH FLOOR
ACADEMIC BLOCK, GB PANT HOSPITAL, NEW DELHI
New Delhi DELHI 110002 India |
| Phone |
9718592450 |
| Fax |
|
| Email |
kirankiro@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr KIRAN LATA KIRO |
| Designation |
PROFESSOR |
| Affiliation |
Govind Ballabh Pant Institute of Postgraduate Medical Education and Research |
| Address |
NEUROANESTHESIA AND CRITICAL CARE,
DEPARTMENT OF ANESTHESIOLOGY AND INTENSIVE CARE, 6TH FLOOR
ACADEMIC BLOCK, GB PANT HOSPITAL, NEW DELHI
New Delhi DELHI 110002 India |
| Phone |
9718592450 |
| Fax |
|
| Email |
kirankiro@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govind Ballabh Pant Institute of Postgraduate Medical Education and Research, 1-Jwahar Lal Nehru Marg, New Delhi 110002, India |
|
|
Primary Sponsor
|
| Name |
Govind Ballabh Pant Institute of Postgraduate Medical Education and Research |
| Address |
Neuroanaesthesia and Critical Care,
Department of Anaesthesiology and Intensive Care,
GIPMER, New Delhi,110002.
|
| Type of Sponsor |
Government medical college |
|
|
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 SUNIL JOE JACOB |
Govind Ballabh Pant Institute of Postgraduate Medical Education and Research |
Room No:17,
Neurosurgery OT,2nd
floor, A block, GB Pant
hospital.
New Delhi
DELHI New Delhi DELHI |
9496290441
drsuniljoejacob@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D321||Benign neoplasm of spinal meninges, (2) ICD-10 Condition: M51||Thoracic, thoracolumbar, and lumbosacral intervertebral disc disorders, (3) ICD-10 Condition: A180||Tuberculosis of bones and joints, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All ASA (American Society of Anaesthesiology) physical status I & II patients, scheduled for elective thoracolumbar and lumbar spine surgery in the prone position. |
|
| ExclusionCriteria |
| Details |
•Impaired left ventricular function (ejection fraction less than 50%).
•Moderate to severe valvular disease.
•ECG Rhythm disturbance.
•Carotid artery disease or stenosis more than 50%.
•Basal Metabolic Index (BMI) more than 30 or less than 15 kg m2
•History of cerebrovascular accident or transient ischemic attack.
•Respiratory system disease affecting lung compliance
•Inability to obtain adequate Carotid Doppler signals.
•Severe peripheral arterial occlusive disease
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
•Change in FTc and Change in CDPV to fluid bolus
•Change in PPV to fluid bolus
•Correlation between FTc and Change in CDPV with PPV
|
1.5 min after induction (supine)- Baseline.
2.5 min after completion of fluid loading.
3.10 min after stabilisation in prone position and check for fluid responsiveness.
4.5 min after 2nd fluid loading (if responsive) in prone position.
5.Every hour intraoperatively.
6.After completion of surgery, patient in the prone position.
7.5min after making the patient supine.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Resistivity Index (RI) trends across intraoperative phase |
1.5 min after induction (supine)- Baseline.
2.5 min after completion of fluid loading.
3.10 min after stabilisation in prone position and check for fluid responsiveness.
4.5 min after 2nd fluid loading (if responsive) in prone position.
5.Every hour intraoperatively.
6.After completion of surgery, patient in the prone position.
7.5min after making the patient supine.
|
|
|
Target Sample Size
|
Total Sample Size="62" Sample Size from India="62"
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)
|
01/05/2026 |
| 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 - YES
- 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).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report Response - Analytic Code
- 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.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drsuniljoejacob@gmail.com].
- For how long will this data be available start date provided 24-06-2028 and end date provided 24-06-2038?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This prospective observational study will be conducted in the Departments of Anaesthesiology and Intensive Care in collaboration with Department of Neurosurgery after Institutional Ethics Committee approval. Adult patients undergoing thoracolumbar and lumbar neurosurgical procedures in the prone position will be enrolled following written informed consent. All participants will undergo standard pre-anaesthetic evaluation including detailed history, clinical examination, and review of laboratory and imaging investigations. Routine medications will be continued until the morning of surgery and standard fasting guidelines followed. In the operating room, standard ASA monitors along with BIS, ABG, TOF, and invasive arterial blood pressure monitoring will be instituted. Anaesthesia will be induced with propofol using target-controlled infusion (Eleveld model), fentanyl, and rocuronium, followed by tracheal intubation. Maintenance will include propofol TCI titrated to maintain BIS 40–60, fentanyl infusion, and rocuronium with volume-controlled ventilation adjusted to maintain normocapnia. Baseline haemodynamic and Carotid Doppler parameters will be recorded after induction. Fluid preloading with 6 ml/kg hydroxyethyl starch will be administered, followed by reassessment. Patients will then be positioned prone using the dual transverse roll technique, and Carotid Doppler parameters reassessed after stabilization. Carotid Doppler parameters and pulse pressure variation will be recorded hourly until surgery completion. At the end of surgery, patient will be made supine and final measurements will be taken. Neuromuscular blockade will be reversed; trachea will be extubated once patient meets the extubation criteria, and patient will be shifted to Intensive Care Unit (ICU) for further management. |