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临床试验/NCT04991220
NCT04991220Unknown不适用

Evaluation of the Changes of Pleth Variability Index During Preoxygenation for Predicting Hypotension During Induction of Anesthesia in Surgical Patients; Prospective Observational Study

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2021年8月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
96
试验地点
1
主要终点
Hypotension during anesthesia induction

研究概览

简要总结

The aim of this study is to investigate whether the change in pleth variation index (PVI) according to preoxygenation can predict hypotension during anesthesia induction.

详细描述

In patients with hypovolemia or dehydration, pulse pressure variation can be increased by spontaneous forced inspiratory breathing. PVI is a noninvasive method of indicator of fluid responsiveness like purse pressure variation. We expected that the amount of change in PVI between at the time of entering operating room and after preoxygenation with forced inspiration method could be different depending on the patient's volume status.

After entering operating room, monitoring devices, anesthesia depth sensor, and Radical-7® Pulse CO-Oximeter® are attached. Patients rest for 5 minutes, and then baseline systolic blood pressure, diastolic blood pressure, mean blood pressure, and heart rate are collected every 1-minute. Pleth variability index (PVI), perfusion index (PI) are also measured continuously. For pre-oxygenation of anesthesia, take 8 deep breaths at flow 10 l/min of 100% oxygen for 1 minute with maximally forced inspiration. After that, for 2 minutes, patients breathe as usual while maintaining oxygen supply. until tracheal intubation or laryngeal mask insertion. Anesthesia is induced with target concentration infusion of 4.0 ng/ml of remifentanil and 4.0 ug/ml of propofol. When the patient loses consciousness, rocuronium 1.0 mg/kg is administrated and endotracheal tube or laryngeal mask is inserted 2 minutes after. PVI, PI, blood pressure, and heart rate are measured until tracheal intubation or laryngeal mask insertion. Anesthesia induction-related hypotension is defined as a decrease in mean arterial pressure below 60 mmHg at any timepoint from baseline parameter collection to until airway device insertion. The parameters are analyzed by comparing between groups with and without anesthesia induction-related hypotension.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adult patients undergoing elective surgery under general anesthesia

排除标准

  • •(1) American Society of Anesthesiologists (ASA) physical status classification III or higher (2) Patients with cognitive impairment who are unable to follow instructions (3) Patients with pulmonary dysfunction (4) Other patients who are judged inappropriate to the experiment by the researcher

研究组 & 干预措施

preoxygenation

Experimental

Taking 8 deep breaths at 10 l/min of 100% oxygen for 1 minute with forced inspiration for pre-oxygenation

干预措施: Preoxygenation (Procedure)

结局指标

主要结局

Hypotension during anesthesia induction

时间窗: from start of anesthesia induction to just before intubation

When mean blood pressure decreases to less than 60 mmHg at least once from the administration of anesthetic agent to just before intubation

次要结局

  • Systolic blood pressure(from entering operating room to just before intubation)
  • Pulse oximetry plethysmographic waveform; ΔPOP(from the administration of anesthetic agent to just before intubation)
  • Heart rate(from entering operating room to just before intubation)
  • Perfusion index(from entering operating room to just before intubation)
  • Pleth Variability Index (PVi®)(from entering operating room to just before intubation)
  • Saturation of percutaneous oxygen(from entering operating room to just before intubation)
  • Diastolic blood pressure(from entering operating room to just before intubation)

研究者

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

Hee-Soo Kim

Professor

Seoul National University Hospital

研究点 (1)

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