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临床试验/NCT04506957
NCT04506957Unknown不适用

Non-invasive Continuous Total Hemoglobin Measurement by Pulse CO-Oximetry in Major Spine Surgery

Klinik Hirslanden, Zurich0 个研究点目标入组 50 人开始时间: 2020年12月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
主要终点
Reliability of SpHb to detect CoOxHb and its changes

研究概览

简要总结

This study is a data collection/sampling project for transcutaneous continuous Pulse CO-Oximetry and accessories (SW-Version Radical-7® Pulse CO-Oximeter with the Masimo rainbow SETTM, V1.6.2.4i Masimo Corp., Irvine, CA, USA, and the RD rainbow SET-2, Rev-O Fingersensor). The device received the CE Mark in 2012 and is approved by the Swiss Medic for clinical use. The Radical-7 device isolates multiple (7+) wavelengths of light of arterial signals using adaptive filters. It provides continuous noninvasive monitoring of arterial oxygen saturation (RadSpO2), pulse rate (RadPR), carboxyhaemoglobin saturation (SpCO), methaemoglobin saturation (SpMET), total haemoglobin concentration in g/dl (SpHb) and/or respiration rate (RRa). Additionally, Low Signal IQ (Low SIQ), Perfusion Index (PI), Pleth Variability Index (PVI), total arterial oxygen content (SpOC), Haematocrit (SpHCT), Signal identification Quality (SIQa), Respiration Indicator (RI) are displayed.The purpose of this prospective study is to investigate the reliability of non-invasive continuously measured SpHb by the Masimo Radical-7® Pulse co-oximeter (Radical 7 device) under steady state conditions by comparison against simultaneously invasive measured arterial haemoglobin concentrations (CoOxHb) in major spine surgery patients, in which high blood loss was expected

详细描述

The objective of this investigation is the comparison of CoOxHb, HCT and SaO2 values of a blood gas analyzer (ABL 825, Radiometer Medical A/S) with simultaneously measured SpHb values of the Radical 7 device during the procedure of major spine surgery.

The primary endpoint of the study is the reliability of SpHb to detect CoOxHb and its changes during the process Secondary endpoint is the reliability of RadSpO2, RadPR, SpHCT and SpMET to detect SaO2, PR, HCT and MetHb and its changes during the process.

Inclusion criteria:

  1. Patients scheduled for major spine surger
  2. Age 18 years and older
  3. Written consent of the participation after clarification about the study

Exclusion criteria:

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

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

  • Patients scheduled for major spine surgery
  • Written consent of the participation after clarification about the study

排除标准

  • No consent to participate
  • No German comprehension
  • Black skin patients
  • Patients with COVID-19 illness

结局指标

主要结局

Reliability of SpHb to detect CoOxHb and its changes

时间窗: 24 months

Co-oximetry hemoglobin values from blood gas analyzer is simultaneous compared with the transcutaneous detected SpHb (Pulse CO-Oximetry hemoglobin measurement). Linear correlation and Bland Altman Analysis are performed for analysis these data pairs

次要结局

未报告次要终点

研究者

发起方
Klinik Hirslanden, Zurich
申办方类型
Other
责任方
Principal Investigator
主要研究者

Werner Baulig

Prof. Dr. med. Werner Baulig

Klinik Hirslanden, Zurich

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