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临床试验/CTRI/2025/07/090028
CTRI/2025/07/090028招募中2/3 期

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

Postgraduate Institute of Medical Education and research, Chandigarh ( INDIA)1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2025年7月14日最近更新:

试验速览

阶段
2/3 期
状态
招募中
发起方
入组人数
76
试验地点
1
主要终点
Time weighted average mean arterial pressure (MAP) less than 65 mmHg (TWA-AUT-65) in both the groups

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
Male

入选标准

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

排除标准

  • 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.

结局指标

主要结局

Time weighted average mean arterial pressure (MAP) less than 65 mmHg (TWA-AUT-65) in both the groups

时间窗: On the day of operation

次要结局

  • Hospital stay(At the end of the day)
  • Intensive Care Unit stay(At the end of the day)
  • 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,)
  • Perioperative fluid intake and blood loss(On the day of operation)
  • Concentration of serum troponin(at baseline, and)
  • Vasopressors and inotropic medication used(From day of operation till end of 7 days)
  • Survival(at day 90 after surgery)
  • GOSE(at discharge,)
  • 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)

研究者

发起方
Postgraduate Institute of Medical Education and research, Chandigarh ( INDIA)
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Shiv Lal Soni

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

研究点 (1)

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