Usefulness of Non-invasive Pulse Co-oximetry Haemaglobin Measurements in Critically Ill Black Patients
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
- 否
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
Susan Murphy
Paediatric Intensivist
Chris Hani Baragwanath Academic Hospital
