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临床试验/NCT05615376
NCT05615376已完成不适用

Beat to Beat A Prospective Study in Paediatric, Adolescent and Young Adult Patients Aged 7 to 18 Years of Age Who Are Undergoing or Have Undergone Cancer Therapy to Evaluate the Agreement Between QTc Measured Using 12 Lead Electrocardiogram (ECG) and a Wearable Device ECG

Murdoch Childrens Research Institute1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2023年2月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
45
试验地点
1
主要终点
Recording of a 12 lead ECG and wearable device ECG

研究概览

简要总结

A prospective study in paediatric, adolescent and young adult patients aged 7 to 18 years to evaluate the agreement between QTc measured using 12 lead electrocardiogram (ECG) and the wearable device ECG.

详细描述

Rationale: Leveraging existing wearable technology has the ability to scale routine screening strategies across large populations and can facilitate ambulatory care. In recent years, wearable technology has rapidly diffused into consumer markets and provides unique opportunities to engage individuals on health issues of personal interest, and to collect personal health data. One example of such technology is the ability to perform electrocardiogram (ECG) type traces on wearable devices. However, utilization of this data source to improve patient outcomes has not been fully realized in the health care field. An app-based heart ECG algorithm that can be remotely analysed for QTc prolongation with potential to then notify the user of such potential irregularities could lead to widespread screening, detection and initiation of treatment solutions (i.e. correction of electrolytes, alteration of exacerbating medications, cardiac monitoring etc).

Trial Design: This will be a prospective, single arm, experimental, non-significant risk study conducted with the assistance of eligible participants. Parents or mature minors will download the Beat to Beat app, once consented.

Once consented the wearable device will be paired to the parent/guardians phone following the steps provided by the wearable device app. Once the device is paired and the study coordinator has assisted with the download of 'Beat to Beat' app, the patients will then be able to commence the ECG readings. A 12 lead ECG will be performed by the study team and immediately following this, an ECG will be recorded on the wearable device. The wearable device will be placed on the left wrist for a Lead I reading, on the left lower abdomen for a Lead II reading and in the fourth intercostal space left parasternal for a chest V2 Lead reading. Recording of the 12 lead ECG and wearable device ECG will be repeated again 4 days later. Once both timepoints (and two device recordings for each time period) have been completed the ECGs will be retrieved from the Beat to Beat app. Both the 12 lead and wearable device ECG will be de-identified and given a patient identifier before being uploaded into the REDCap database.

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
7 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Paediatric or adolescent diagnosis of cancer AND an inpatient of The Royal Children's Hospital, Melbourne for at least 5 days at the time of consent.
  • •Patient age ≥ 7 years at time of eligibility screening
  • •If age < 18 years, parent or guardian able to provide consent
  • •Parental or participant ( if > 18 years of age) possession of the following at time of eligibility screening, ascertained from automatic hardware/software/device pairing check:
  • •iPhone (6s or later) with iOS version 15.0 or later defined as iPhone model/iOS version used to complete screening eligibility.
  • •Proficient in written and spoken English, defined by self-report of comfort reading, writing, and speaking English on iPhone.
  • •Valid phone number associated with iPhone, ascertained from self-report.
  • •Valid email address, ascertained from self-report.
  • •Participants or parents need to be able to press down on the wearable device crown for 30 seconds

排除标准

  • •Unable to wear the wearable device.
  • •< 18 years of age without guardian or parent to provide consent.
  • •Interpreter required for consent purposes.

研究组 & 干预措施

ECG App arm

Experimental

Participants will be provided with a wearable device on Day 1 and Day 4 whilst admitted in hospital.

干预措施: ECG application (Device)

ECG App arm

Experimental

Participants will be provided with a wearable device on Day 1 and Day 4 whilst admitted in hospital.

干预措施: 12 lead ECG (Device)

结局指标

主要结局

Recording of a 12 lead ECG and wearable device ECG

时间窗: Day 4 of inpatient stay

12 lead ECG and wearable device ECG recordings will be taken at the time point of care. The wearable device ECG will be placed on the left wrist to record a V1 (lead I) ECG and on the left ankle to record a V2 (lead II) ECG reading from which the QT interval can be calculated.

Calculation of QT interval by two blinded health professionals

时间窗: Day 4 of inpatient stay

The wearable device ECG and 12 lead ECG will be de-identified and given appropriate study numbers. This data will be listed separately for each patient. The QT interval for each recording will be calculated. This is the time corresponding to beginning of depolarization to repolarization of the ventricles. It is calculated using a standardised approach (Fridericia's formula:QTcF = QT divided by cube root of RR).

Recording of a 12 lead ECG and wearable device ECG

时间窗: Day 1 of inpatient stay

12 lead ECG and wearable device ECG recordings will be taken at the time point of care. The wearable device ECG will be placed on the left wrist to record a V1 (lead I) ECG and on the left ankle to record a V2 (lead II) ECG reading from which the QT interval can be calculated.

Calculation of QT interval by two blinded health professionals

时间窗: Day 1 of inpatient stay

The wearable device ECG and 12 lead ECG will be de-identified and given appropriate study numbers. This data will be listed separately for each patient. The QT interval for each recording will be calculated. This is the time corresponding to beginning of depolarization to repolarization of the ventricles. It is calculated using a standardised approach (Fridericia's formula:QTcF = QT divided by cube root of RR).

次要结局

  • To calculate the interobserver variability between the two health care professional readings of QTc.(Day 4 inpatient stay)
  • Sensitivity calculations of wearable device vs 12 Lead ECG(Day 4 inpatient stay)
  • Specificity calculations of wearable device vs 12 Lead ECG(Day 4 inpatient stay)
  • Number of Participants with Abnormal QTc that is greater than 0.48mm on 12 lead ECG and wearable device ECG(Day 4 inpatient stay)
  • Number of Participants with Abnormal QTc that is greater than 0.48mm on 12 lead ECG and wearable device ECG(Day 1 inpatient stay)
  • Sensitivity calculations of wearable device vs 12 Lead ECG(Day 1 inpatient stay)
  • Specificity calculations of wearable device vs 12 Lead ECG(Day 1 inpatient stay)
  • To calculate the interobserver variability between the two health care professional readings of QTc.(Day 1 inpatient stay)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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