A Single Centre Study Comparing a Continuous Non-invasive Lactate Sensor Measurement to Standard Invasive Measurements of Venous and Arterial Lactate in Patients Undergoing Elective Coronary Artery Bypass Graft +/- Valve Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Continuous lactate sensor measurement compared venous and arterial blood gas lactate measurements.
研究概览
简要总结
The main goal of this study is to see how well a non-invasive lactate sensor measures lactate levels compared to standard blood tests. This might reduce the need for frequent blood draws during surgery recovery, and also provide a more comfortable experience for patients. This will also give us information regarding the suitability of the lactate sensor for monitoring other patients - for instance people attending the accident and emergency department with chest pain in which lactate levels may help make a quick diagnosis.
Patients will be approached for this study if they are undergoing routine coronary artery bypass surgery (CABG) or valve replacement surgery. Participants will wear the non-invasive lactate sensor for up to 14 hours, and the readings will be correlated to lactate levels in blood samples. Once the sensor has been removed and the participant has been discharged from their elective surgery admission, the participant has completed the study.
Participation in this study and the data collected from the sensor will help us understand how well it works and how it can be used to improve patient care in the future.
In the future, the data from this new device will be used to train computer algorithms to provide quick responses that could help manage a patients condition, improving future medical care.
详细描述
Summary of the study design and methodology
The research nurse or doctor will meet with the patient to explain the study and check the following:
Pre-screening: The research nurse, who may also be part of the patients direct care team will look at the records for patients who are attending St Bartholomews hospital for cardiac surgery for grafts and or valve replacement.
Informed Consent: If the patient is eligible and wishes to participate in the study, a qualified individual from the research team will obtain their consent. If the person obtaining the consent is not a doctor, the participant will be given the opportunity to discuss the study with a medically qualified individual.
Screening: The research nurse or doctor will collect demographic information from the patient and ensure the patient meets the study's inclusion and exclusion criteria.
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
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able and willing to give informed consent
- •≥18 to ≤ 90 years old
- •Successful surgery as defined by the below criteria (which will be recorded in the eCRF):
- •Operative Success: The successful completion of coronary artery bypass grafting (CABG) +/- valve insertion with grafts and/or valves
- •Absence of the following complications:
- •Significant bleeding requiring reoperation
- •Evidence of major life-changing stroke
排除标准
- •Previous coronary artery bypass grafting
- •Recent acute coronary syndrome (within 4 weeks of consent date)
- •Heart failure with EF <35% (from TTE or CT from past 6 months - if both available lower value will be used).
- •Chronic severe renal failure (estimated eGFR less than 30 mL/min/1.73m2 by the MDRD formula recorded within 6 months of planned consent date)
- •Severe anaemia (<10 recorded within 6 months of planned consent date)
- •Known or suspected allergies to medical grade silicone adhesives
- •Pre-existing skin condition on the upper arm where the device would be applied, including recent burns/ scalds, open wounds or clinically significant skin lesions.
- •Patients with implanted medical devices such as pacemakers or other CLMs
- •Severe liver cirrhosis (≥ stage III)
- •Lymphoedema or pitting oedema at the time of consent
- •Pregnancy
- •History of ongoing malignant disease
- •Hypoalbuminaemia (<35 g/L recorded within 6 months of consent date)
- •Those lacking capacity to consent or are deemed vulnerable adults
- •Unable to speak English
研究组 & 干预措施
Lactate Sensor Device Arm
Continuous interstitial fluid lactate monitoring using the non-invasive Nemaura Investigational Lactate Device.
干预措施: Lactate sensor (Device)
结局指标
主要结局
Continuous lactate sensor measurement compared venous and arterial blood gas lactate measurements.
时间窗: 14 hours
Correlation coefficients describing the strength of association between a non-invasive continuous lactate sensor measurement (using a commercially developed investigational device by Nemaura Pharma Ltd) and local Radiometer ABL 90, venous and arterial blood gas lactate measurements (both absolute and change) measured hourly up to 12 samples within a 14-hour period post-elective CABG +/- valve replacement surgery.
Continuous lactate sensor measurement compared Troponin-T
时间窗: 14 hours
Correlation coefficients describing the strength of association between a non-invasive continuous lactate sensor measurement (using a commercially developed investigational device by Nemaura Pharma Ltd) and venous laboratory measurements of high-sensitivity troponin-T measured hourly up to 12 samples within a 14-hour period post-elective CABG +/- valve replacement surgery.
次要结局
- Relationship between arterial and venous lactate measurements(14 hours)
- Evaluate safety of lactate sensor(24 hours)
- Relationship between arterial and venous lactate and venous troponin measurements(14 hours)