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临床试验/NCT02035306
NCT02035306已完成不适用

Usefulness of Non-invasive Pulse Co-oximetry Haemaglobin Measurements in Critically Ill Black Patients

Chris Hani Baragwanath Academic Hospital1 个研究点 分布在 1 个国家目标入组 149 人开始时间: 2014年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
149
试验地点
1
主要终点
Accuracy and precision of non invasive haemaglobin measurement.

研究概览

简要总结

To answer the question whether a non-invasive haemaglobin measurement is clinically useful, reliable and accurate as compared to taking a blood sample and checking the haemaglobin level at the laboratory or in a blood gas analyser. This study will take place in a multi-disciplinary ICU of critically ill patients.

详细描述

A presenting sample of 150 patients requiring admission to ICU will be enrolled. These will include paediatric, trauma, adult medical and adult surgical patients. Informed consent will be obtained. Baseline demographic data, vital signs, Massey pigmentation score, and severity of illness scores will be calculated, as well as finger deformity, if present, nail polish or acrylics, smoking habits, finger diameter of finger measured, comorbidities and medications. Patients will be admitted in the usual way, and admission bloods will be sent to the laboratory as per usual protocol. Enrolled patients will in addition have their Haemaglobin and Plethysmography Index (measure of perfusion) measured non-invasively using the Masimo Pronto-7 handheld device. Note of concurrent medications, blood products and vital signs will be recorded at each measurement. Each patient will have measurements done 8 hourly (between 1-5 measurements per patient). Concurrent arterial blood gas samples will be taken in a heparinised syringe and performed on ABL radiometer blood gas analyser.. An additional EDTA blood sample shall be taken at each Pronto measuring point which will be measured at the laboratory on a Sysmex cell counter. Analysis of data will assess precision and accuracy, trend accuracy, and effect of pigmentation, vasopressors and other medication on the results of the non-invasive co-oximetry estimation of haemaglobin.

研究设计

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

入排标准

年龄范围
1 Month 至 100 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients with a condition that requires admission to ICU shall be considered to be eligible.
  • Age 1month to 100years old

排除标准

  • Patients under 1 month old
  • Patients with an unrecordable blood pressure or body temperature <34 degrees.

结局指标

主要结局

Accuracy and precision of non invasive haemaglobin measurement.

时间窗: during ICU admission

Accuracy and precision of non invasive hemoglobin (Hb) measurement to invasive co-oximetry (blood gas analyser), and laboratory haemaglobin measurement. For comparative purposes in our population (dark skinned patients, low Hb levels and during active transfusion) our outcome aim for Hb accuracy will be based on what Masimo has found previously in 11 335 comparisons. These are: * 0.99g/dl at 1SD * Hb between 6g/dl and 12g/dl : 95% of readings within 2g/dl of laboratory value * Hb between 12g/dl and 18g/dl : 95% of readings within 2g/dl of laboratory value Precision shall be described as a co-efficient of variation

次要结局

  • Cost of test(during ICU admission)
  • Effect of skin pigmentation on result(during ICU admission)
  • Effect of patients clinical state on test results.(during ICU admission)
  • Time to result(during ICU admission)

研究者

发起方
Chris Hani Baragwanath Academic Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Susan Murphy

Paediatric Intensivist

Chris Hani Baragwanath Academic Hospital

研究点 (1)

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