Real Time ST-segment Deviation Detection in High-risk Patients Detected by Wireless Single-lead ECG
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 698
- 试验地点
- 1
- 主要终点
- Frequency of patients with ST-deviation <-0.255 and/or >0.245 mV on single-lead ECG
研究概览
简要总结
This study primarily aims to describe the frequency of significant ST-deviations, defined as ECG-ST-deviations <-0.255 or >0.245 mV for a minimum duration of 30 minutes as measured by a single-lead ECG in patients admitted with AECOPD or following major abdominal surgery. Secondarily we will describe the frequency of ST-deviations <-0.255 or >0.245 mV for a minimum duration of 1, 10 and 20 minutes, respectively, as well as for patients with ST-deviations <-0.1 or >0.1 mV for a minimum duration of 1, 10, 20 and 30 minutes, respectively. Lastly, we will investigate the association between ST-deviations and subsequent myocardial injury while adjusting for known risk factors.
详细描述
Background:
Assesment of wireless ECG-monitoring devices is essential for patient monitoring as it enables activity and out-of-hospital monitoring. Former studies have found a random variation for ST-deviations between wireless single-lead ECG and 12-lead ECG, which suggests that clinical monitoring of ST-deviations by single-lead ECG must be corrected for this to minimize false positive cases. Thus, we aimed to assess how a corrected limit of agreement for ST-deviations affects the ability to detect true myocardial ischemia by comparing thresholds to troponin elevations.
Methods:
This study sought to analyze data from two WARD cohort studies (NCT03491137) and (NCT03660501). Patients were included at Rigshospitalet and Bispebjerg Hospital from February 2018 to September 2020. The Surgery and COPD studies consisted of 505 and 202 patients, respectively, who were hospitalized with AECOPD or scheduled for elective major abdominal surgery lasting > 2 hours. All patients were monitored with wireless equipment, which continuously measured vital signs. The continuous wireless monitoring used in this study consisted of a single-lead ECG patch (Isansys Life Touch patch) which consists of two ECG electrodes placed on the left side of the patients' thorax. The patch measures respiratory rate (RR), heart rate (HR), heart rate variability (HRV) and electrocardiogram (ECG)s. Another monitoring device was the plasma concentration of high-sensitive cardiac troponin T (hsTnT, Cobas 8000, e801 module, Diagnostics Roche). In this study, patients were divided into a myocardial injury group with TnT elevations (of 20-64 ng/L with an absolute change of ≥ 5 ng/L, or a hsTnT level ≥65 ng/L, both evaluated as due to ischemic etiology) and a group with no myocardial injury.
Analysis:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years
- •Patients admitted to emergency departments or pulmonary wards with AECOPD as admission diagnosis with suspected acute exacerbation of COPD
- •The diagnosis had to be sustained in the patient record at the time of inclusion
- •Expected admittance longer than 24 hours
- •Possibility of an investigator to include the patient within 24 hours from admission
- •WARD-Surgery:
- •≥ 60 years
- •Elective major abdominal cancer surgery
- •Estimated surgical duration ≥ 2 hours.
排除标准
- •Patients who were not expected to cooperate to wear the monitoring equipment
- •Unable to give informed consent
- •Patients who were withheld active treatment
- •Implanted cardioverter defibrillator or pacemaker
- •Severe allergy for plaster/silicone
- •WARD-Surgery:
- •Implanted cardioverter defibrillator or pacemaker
- •Allergy to study devices
- •Severe cognitive impairment assessed by MMSE
- •Inability to cooperate wearing the wireless monitoring equipment
结局指标
主要结局
Frequency of patients with ST-deviation <-0.255 and/or >0.245 mV on single-lead ECG
时间窗: 30 minutes
The primary outcome is the frequency of patients with ST-deviation \<-0.255 and/or \>0.245 mV (0.1 mV + LoA) on single-lead ECG monitoring lasting ≥ 30 minutes.
次要结局
- Frequency of patients with ST-deviation <-0.255 and/or >0.245 mV lasting ≥ 30 minutes and myocardial injury within three days of the first continuous monitoring day.(3 days)
- Frequency of patients with ST-deviation <-0.255 and/or >0.245 mV lasting ≥ 1 minute.(1 minute)
- Frequency of patients with significant ST-deviations <-0.1 and/or >0.1 mV lasting ≥ 1 minute.(1 minute)
- Frequency of patients with significant ST-deviations <-0.1 and/or >0.1 mV lasting ≥ 20 minutes.(20 minutes)
- Frequency of patients with ST-deviation <-0.255 and/or >0.245 mV lasting ≥ 20 minutes.(20 minutes)
- Frequency of patients with significant ST-deviations <-0.1 and/or >0.1 mV lasting ≥ 10 minutes.(10 minutes)
- Frequency of patients with significant ST-deviations <-0.1 and/or >0.1 mV lasting ≥ 30 minutes.(30 minutes)
- Frequency of patients with ST-deviation <-0.255 and/or >0.245 mV lasting ≥ 10 minutes.(10 minutes)
研究者
Jonathan Attilla Koefoed Starling
Medical Student
Rigshospitalet, Denmark