Non-invasive Continuous Total Hemoglobin Measurement by Pulse CO-Oximetry in Major Spine Surgery
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:
- Patients scheduled for major spine surger
- Age 18 years and older
- 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
- 否
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
Werner Baulig
Prof. Dr. med. Werner Baulig
Klinik Hirslanden, Zurich
