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临床试验/NCT06141681
NCT06141681招募中不适用

Evaluation of Microcirculation With Photoplethysmography (Pulse Oximetry) in Healthy Volunteers and Ventilated Patients

Hospital Privado de Comunidad de Mar del Plata1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年6月19日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
20
试验地点
1
主要终点
variations in AC signal of photoplethysmography

研究概览

简要总结

The objective of this observational study is to explore microcirculation in healthy volunteers and in ventilated patients in the operating room and in critical care.

The general objective of this study is to evaluate microcirculation with photoplethysmography (PPG) in different pathophysiological situations and to compare PPG with available standard methods. Specifically, evaluate the correlation between the determinations of AC-DC waves obtained by Photoplethysmography (PPG) and those obtained in different dynamic tests in healthy volunteers.

To compare microcirculation assessments [capillary refill time (CRT), perfusion index (PI), perfusion index variability (PIV)] with measurements obtained by PPG in the context of critically ill patients.

To compare microcirculation assessments (CRT, PI PVI) with measurements obtained by PPG in the context of patients on invasive mechanical ventilation (IMV) in the operating room and in critical care.

详细描述

An attempt is made to explore different physiological aspects that affect microcirculation such as vascular tone and blood volume.

Photoplethysmography usually examines the AC wave equivalent to the pulsatile wave, however the DC component has been less explored and can account for the microcirculation and volemia status of the subjects.

Since there is no gold standard, it will be compared against different validated methods.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

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

入选标准

  • Written informed consent.
  • Age > 18 years.

排除标准

  • Pregnancy.
  • Respiratory and/or cardiovascular pathologies.
  • Peripheral vascular disease.
  • Operation room or Critical care Unit patients
  • Inclusion criteria:
  • Written informed consent.
  • Age > 18 years.
  • Critical patients ventilated in the ICU of any origin.
  • Exclusion criteria:
  • Known peripheral vascular disease.
  • Burns on both upper limbs.
  • Trauma to both upper limbs.

结局指标

主要结局

variations in AC signal of photoplethysmography

时间窗: Through study completion, an average of 1 year

Changes in the AC wave of photoplethysmography (it does not currently have standardized measurement units) will be evaluated in each functional test (CRT, LPR, venous occlusion test, progressive arterial occlusion test). It will be treated as a continuous numerical variable.

variations in DC signal of photoplethysmography

时间窗: Through study completion, an average of 1 year

Changes in the DC wave of photoplethysmography (it does not currently have standardized measurement units) will be evaluated in each functional test (CRT, LPR, venous occlusion test, progressive arterial occlusion test). It will be treated as a continuous numerical variable.

次要结局

未报告次要终点

研究者

发起方
Hospital Privado de Comunidad de Mar del Plata
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nora Angélica Fuentes

Principal Investigator

Hospital Privado de Comunidad de Mar del Plata

研究点 (1)

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