| CTRI Number |
CTRI/2025/07/090028 [Registered on: 02/07/2025] Trial Registered Prospectively |
| Last Modified On: |
02/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Smart Monitoring Algorithm with Traditional Methods to Prevent Low Blood Pressure During Brain Aneurysm Surgery: A Clinical Study |
|
Scientific Title of Study
|
Effect of predictive prevention algorithm based on HPI versus conventional PPV based hemodynamic management on intraoperative hypotension in surgeries for intracranial space occupying lesions: A randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IEC-INT/2024/Study-1925 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shiv Lal Soni |
| Designation |
Additional Professor |
| Affiliation |
Postgraduate Institute of Medical Education and research, Chandigarh ( INDIA) |
| Address |
5th floor, Nehru Hospital, Postgraduate Institute of Medical Education and research, Sector 12, Chandigarh (INDIA)
Chandigarh
CHANDIGARH
160012
India |
| Phone |
09914208550 |
| Fax |
|
| Email |
dr.shivsoni@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shiv Lal Soni |
| Designation |
Additional Professor |
| Affiliation |
Postgraduate Institute of Medical Education and research, Chandigarh ( INDIA) |
| Address |
5th floor, Nehru Hospital, Postgraduate Institute of Medical Education and research, Sector 12, Chandigarh (INDIA)
Chandigarh
CHANDIGARH
160012
India |
| Phone |
09914208550 |
| Fax |
|
| Email |
dr.shivsoni@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shiv Lal Soni |
| Designation |
Additional Professor |
| Affiliation |
Postgraduate Institute of Medical Education and research, Chandigarh ( INDIA) |
| Address |
5th floor, Nehru Hospital, Postgraduate Institute of Medical Education and research, Sector 12, Chandigarh (INDIA)
Chandigarh
CHANDIGARH
160012
India |
| Phone |
09914208550 |
| Fax |
|
| Email |
dr.shivsoni@gmail.com |
|
|
Source of Monetary or Material Support
|
| Postgraduate Institute of Medical Education and Research, Sector-12, Chandigarh, INDIA, Pincode:- 160012 |
|
|
Primary Sponsor
|
| Name |
Postgraduate Institute of Medical Education and research, Chandigarh ( INDIA) |
| Address |
Postgraduate Institute of Medical Education and research, Sector 12, Chandigarh-160012,(INDIA) |
| 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 Shiv Lal Soni |
Postgraduate Institute of Medical Education and Research, Chandigarh |
Neurosurgical OT Complex, Nehru Hospital, Postgraduate Institute of Medical Education and Research, Chandigarh-160012
Chandigarh
CHANDIGARH |
9914208550
dr.shivsoni@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Postgraduate Institute of Medical Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I607||Nontraumatic subarachnoid hemorrhage from unspecified intracranial artery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group HPI |
Patients in HPI group will be monitored with EV 1000 HPI monitor (Edwards Lifescience) and management will be done as per study protocol. Firstly, baseline variables as provided by EV1000 monitor will be noted before induction of anaesthesia and measures will be taken to keep stroke volume variation (SVV) 13%, (Systemic Vascular Resistance) SVR 800, cardiac index (CI) baseline and Mean Arterial Pressure (MAP) 65 mmHg. Anesthesiologist intervention will be initiated if HPI85%. An in-room investigator will assign the HPI alert to one of 4 pre-decided interventions as (1) vasopressors, (2) inotropes, (3) fluids and (4) Observation. In the event MAP is less than 65 mmHg irrespective the HPI algorithm will be start at the SVV stage, however the treating anesthesiologist will be free to deviate from the algorithm as needed (such deviations will be recorded). |
| Comparator Agent |
Group PPV |
PPV will be measured continuously from the Datex-Ohmeda S/5 Avance Anesthesia workstation’s invasive arterial monitoring waveform and hemodynamic management will be initiated as per the algorithm based on PPV values. The EV1000 sensor will be connected to the patient however the clinician will be unaware of the parameters displayed using EV1000 sensor (screen display will be closed and audible alerts will be off). |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Male |
| Details |
Presenting for craniotomy under general anaesthesia for intracranial lesions.
AS I and II
Age above than 18 years
Written informed consent
|
|
| ExclusionCriteria |
| Details |
Refusal of consent
Surgery without controlled ventilation/monitored anaesthesia care
Contraindication to invasive blood pressure monitoring
Atrial fibrillation
Pregnancy
Massive Ascites
GCS less than 15
Known pulmonary disease (Asthma, COPD, interstitial lung disease, current smoker)
Known intracardiac shunts and severe valvular heart disease.
Patient with ongoing active infection |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time weighted average mean arterial pressure (MAP) less than 65 mmHg (TWA-AUT-65) in both the groups |
On the day of operation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time weighted average MAP less than 60 mm Hg (TWA-AUT-60) |
On the day of operation |
| Time weighted average MAP less than 55 mm Hg (TWA-AUT-55) |
On the day of operation |
| Time weighted average MAP less than 50 mm Hg (TWA-AUT-50) |
On the day of operation |
| Serum creatinine |
After 24 hours,
48 hours, and
72 hours |
| Hospital stay |
At the end of the day |
| Intensive Care Unit stay |
At the end of the day |
| Perioperative fluid intake and blood loss |
On the day of operation |
| Concentration of serum troponin |
at baseline, and
day 1 postoperative |
| Vasopressors and inotropic medication used |
From day of operation till end of 7 days |
| Survival |
at day 90 after surgery |
| GOSE |
at discharge,
3 months, and
1 year |
| Number of events of hypotension (MAP less than 65 mm Hg) |
On the day of operation |
| Predictive value of HPI in predicting MAP less than 65 mmHg in the control group |
On the day of operation |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
14/07/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Intraoperative hypotension is one of the commonest adverse events in neurosurgery. It is associated with increased mortality and morbidity in the postoperative period such as cerebral infarction. Incidence of intraoperative hypotension varies from 5% - 99%. The causes for IOH during neurosurgery include anaesthetic drugs, uncorrected hypovolemia, pre-existing co – morbidities, use of osmotherapy, bleeding and surgical manipulation. The Hypotension Prediction Index (HPI) represents a pioneering advancement in hemodynamic monitoring, anticipating intraoperative hypotensive episodes before they occur. Through a sophisticated software algorithm, HPI evaluates data collected by invasive blood pressure monitoring sensors, providing early insights into the factors contributing to impending hypotension and guiding timely interventions to address hemodynamic instability. Given the strong association between hypotension and postoperative complications, including increased risks of myocardial infarction, cerebrovascular incidents, and prolonged hospital stays, it is conceivable that timely and appropriate interventions by anaesthesiologists could mitigate such damage. These interventions aim to reduce both the frequency and duration of intraoperative hypotension, potentially leading to improved patient outcomes. |