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临床试验/NCT05341167
NCT05341167已完成不适用

Use of the Hypotension Prediction Index Algorithm (HPI) for the Prevention of Intraoperative Hypotension (IOH) in Adult Patients Undergoing Spinal Surgery: Study Protocol for a Randomized Clinical Trial

Attikon Hospital2 个研究点 分布在 1 个国家目标入组 85 人开始时间: 2022年5月11日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
85
试验地点
2
主要终点
Time-weighted average (TWA) in hypotension

研究概览

简要总结

The aim of this study is to investigate the hypothesis that the use of the Hypotension Prediction Index algorithm (HPI) can reduce intraoperative hypotension (IOH) in adult patients undergoing spinal surgery in the prone position under general anesthesia, as well as to explore its effect on in-hospital postoperative morbidity and mortality.

详细描述

The study is a Prospective Randomized clinical trial. Adult patients (>18y) undergoing spinal surgery in the prone position under general anesthesia will be included.

The patients will be randomized using a computer-generated, permuted block randomization with a 1:1 allocation into two groups.

Intervention group: in this group, the HPI algorithm will be used in order to prevent hypotensive episodes Control group: in this group standard anesthetic care will be provided. Hypotensive episodes will be treated with vasoactive agents and fluids.

All patients will receive the same type of anaesthesia (TIVA with propofol) and monitoring including Patient State Index (PSI), non-invasive monitoring of blood pressure, SpO2, continuous electrocardiographic monitoring, ETCO2 and urinary output. Additionally, invasive continuous measurement of the patient's blood pressure will be available via radial artery catheterization. The arterial catheter will be connected to both the standard monitor and the platform which includes the HPI software. Arterial blood gas testing will be performed on an hourly basis.

Intraoperative recordings include PSI values, hemodynamic parameters every 10-15 minutes and urinary output every hour. Hemodynamic parameters will also be collected electronically from the monitor. The total doses of propofol, opioids/sedatives, fluids and vasoactive agents will also be recorded, as well as the estimated blood loss.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

盲法说明

Not aware of the study group

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients undergoing scheduled spine surgery performed in prone position under general anaesthesia

排除标准

  • Heart failure with reduced ejection fraction (LVEF<35%)
  • Severe aortic and/or mitral regurgitation
  • Persistent atrial fibrillation or other significant cardiac arrhythmias
  • Significant preoperative hypotension
  • End-stage renal disease on dialysis/RRT

研究组 & 干预措施

Intervention group:

Active Comparator

The HPI algorithm will be used in order to prevent hypotensive episodes. When the HPI is greater than 85%, the anesthesiologist will have to intervene within the next 2 minutes taking the hemodynamic parameters available into consideration, as well as the treatment protocol that has been designed according to current literature

干预措施: Vasoactive Agent (Drug)

Control group:

Other

Hypotensive episodes will be treated with vasoactive agents and fluids according to the standard clinical practice. The HPI algorithm recordings will be blinded and will not be available to the anesthesiologist for the duration of the operation.

干预措施: Vasoactive Agent (Drug)

结局指标

主要结局

Time-weighted average (TWA) in hypotension

时间窗: Up to 15 minutes after the end of operation

Time-weighted average (TWA) in hypotension will be calculated in all patients.

次要结局

未报告次要终点

研究者

发起方
Attikon Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Paraskevi Matsota

Prof of Anestehsiology

Attikon Hospital

研究点 (2)

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