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Comparing Smart Monitoring Algorithm with Traditional Methods to Prevent Low Blood Pressure During Brain Aneurysm Surgery: A Clinical 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 - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/07/090028
Enrollment
76
Registered
2025-07-02
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I607- Nontraumatic subarachnoid hemorrhage from unspecified intracranial artery

Interventions

Intervention1: 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 provi

Sponsors

Postgraduate Institute of Medical Education and research, Chandigarh ( INDIA)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Presenting for craniotomy under general anaesthesia for intracranial lesions. AS I and II Age above than 18 years Written informed consent

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Time weighted average mean arterial pressure (MAP) less than 65 mmHg (TWA-AUT-65) in both the groupsTimepoint: On the day of operation

Secondary

MeasureTime frame
Time weighted average MAP less than 60 mm Hg (TWA-AUT-60)Timepoint: On the day of operation;Time weighted average MAP less than 55 mm Hg (TWA-AUT-55)Timepoint: On the day of operation;Time weighted average MAP less than 50 mm Hg (TWA-AUT-50)Timepoint: On the day of operation;Serum creatinineTimepoint: After 24 hours, 48 hours, and 72 hours;Hospital stayTimepoint: At the end of the day;Intensive Care Unit stayTimepoint: At the end of the day;Perioperative fluid intake and blood lossTimepoint: On the day of operation;Concentration of serum troponinTimepoint: at baseline, and day 1 postoperative;Vasopressors and inotropic medication usedTimepoint: From day of operation till end of 7 days;SurvivalTimepoint: at day 90 after surgery;GOSETimepoint: at discharge, 3 months, and 1 year;Number of events of hypotension (MAP less than 65 mm Hg)Timepoint: On the day of operation;Predictive value of HPI in predicting MAP less than 65 mmHg in the control groupTimepoint: On the day of operation

Countries

India

Contacts

Public ContactDr Shiv Lal Soni

Postgraduate Institute of Medical Education and research, Chandigarh ( INDIA)

dr.shivsoni@gmail.com09914208550

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026