跳至主要内容
临床试验/NCT04217226
NCT04217226已完成不适用

Evaluation of Perfusion Index-derived Parameters as Predictors of Hypotension After Induction of General Anaesthesia: a Prospective Cohort Study.

Cairo University1 个研究点 分布在 1 个国家目标入组 93 人开始时间: 2020年1月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
93
试验地点
1
主要终点
The area under receiver operating characteristic (AUROC) curve for perfusion index to predict hypotension after induction of anesthesia

研究概览

简要总结

The perfusion index (PI) is a numerical value for the ratio between pulsatile and non-pulsatile blood flow measured by a special pulse oximeter. PI represents the baseline sympathetic tone which is assumed one of the factors contributing for hypotension. Patients with low PI were reported by Mahendale and Rajasekhar to show greater hypotension after induction of anesthesia. This was explained by the high sympathetic tone in these patients which is suddenly masked by propofol administration leading to profound hypotension.

This study aims to evaluate the ability of preoperative plethysmographic variability index, perfusion index and the Dicrotic Plethysmography to predict post-induction hypotension.

详细描述

The perfusion index (PI) is a numerical value for the ratio between pulsatile and non-pulsatile blood flow measured by a special pulse oximeter. PI represents the baseline sympathetic tone which is assumed one of the factors contributing for hypotension. Patients with low PI were reported by Mahendale and Rajasekhar to show greater hypotension after induction of anesthesia. This was explained by the high sympathetic tone in these patients which is suddenly masked by propofol administration leading to profound hypotension. Moreover, The PI has been described as a reliable tool for vascular tone assessment and monitoring.

Dicrotic Plethysmography (Dicpleth): is easily derived from the photoplethysmographic signal. It represents the relative height of the dicrotic wave compared with the maximum peak of the waveform, has been described as the amount of reflected wave, dependent on the vascular tone. M.Coutrot et al quantified Dicpleth variations to detect arterial hypotension and mentioned that Dicpleth and PI are both related to vascular tone and are easily derived from the photoplethysmographic signal. Moreover, Chowienczyk PJ et. al. demonstrated that the reduction in Dicpleth is related to the reduction of vascular tone caused by vasodilator drugs, such as salbutamol or glyceryl trinitrate

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 59 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • • Adult patients (18-59 years)
  • Patients scheduled for elective surgeries under general anaesthesia

排除标准

  • • Operations which will last for less than 15 minutes.
  • Patients with cardiac morbidities (impaired contractility with ejection fraction < 40% and tight valvular lesions, unstable angina).
  • Patients with heart block and arrhythmia (atrial fibrillation and frequent ventricular or supraventricular premature beat).
  • Patient with decompansted respiratory disease (poor functional capacity, generalized wheezes, peripheral O2 saturation < 90% on room air).
  • Patients with peripheral vascular disease or long standing DM affecting PVI readings.
  • Pregnancy.

结局指标

主要结局

The area under receiver operating characteristic (AUROC) curve for perfusion index to predict hypotension after induction of anesthesia

时间窗: 10 minutes

PI will be recorded in the supine position by an anaesthesiologist who was not involved in the further intraoperative monitoring of the patient using Masimo SET

次要结局

  • diastolic arterial blood pressure(5 minutes)
  • Heart rate(5 minutes)
  • Mean arterial blood pressure(15 minutes)
  • Dicrotic Plethysmography(10 minutes)
  • systolic arterial blood pressure(5 minutes)
  • Incidence of post-induction hypotension(15 minutes after induction of anesthesia)
  • Plethysmographic variability index(10 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bassant M. Abdelhamid

associate professor

Cairo University

研究点 (1)

Loading locations...

相似试验