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Real Time ST-segment Deviation Detection in High-risk Patients Detected by Wireless Single-lead ECG

3 de janeiro de 2022 atualizado por: Jonathan Attilla Koefoed Starling, Rigshospitalet, Denmark
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.

Visão geral do estudo

Descrição detalhada

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:

Baseline characteristics of patients undergoing major abdominal surgery and patients admitted with AECOPD with and without myocardial injury will be summarized in frequency tables including Using descriptive statistics, we will describe the occurrence of ST-segment deviations in the single-lead (Lifetouch) ECG in patients with and without myocardial injury as well as the association between ST-deviation and subsequent myocardial injury, which will be adjusted for known risk factors; age, gender, BMI, daily smoker (never-, previous-, current smoker), alcohol consumption (none, below- or above recommendations), ASA classification (ASA 1,2,3,4), history of myocardial infarction, history of diabetes mellitus, history of chronic heart failure. Furthermore, the sensitivity and specificity of continuous wireless single-lead ECG with the applied threshold of <-0.255 mV and > 0.245 mV will be determined. Receiver operating characteristics (ROC) analyses will be made to determine which type of ST-deviation and which specific threshold value was most sensitive for TnT elevations. Through ROC analyses it will also be examined how different variations of durations affect the thresholds' sensitivity and specificity. Statistical analysis will be performed using statistical software SPSS.

Tipo de estudo

Observacional

Inscrição (Real)

698

Contactos e Locais

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Locais de estudo

      • Copenhagen, Dinamarca, 2100
        • Rigshospitalet, Department of Anesthesiology, Centre for Cancer and Organ Diseases, University of Copenhagen, Blegdamsvej 9, 2200 Copenhagen, Denmark

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra Não Probabilística

População do estudo

Patients from the two WARD studies: WARD COPD and WARD Surgery. Patients were included at Rigshospitalet (department of abdominal surgery) and Bispebjerg Hospital (departments of emergency medicine, pulmonary medicine, and abdominal surgery) in Denmark from February 2018 to September 2020 after obtained written informed consent. Eligibility was determined by the investigator. All patients were monitored with wireless equipment, which continuously measures vital signs.

Descrição

Inclusion Criteria:

WARD-COPD:

  • ≥ 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.

Exclusion Criteria:

WARD-COPD:

  • 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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Intervenção / Tratamento
no myocardial injury
In this study, patients were divided into groups of myocardial injury, where patients had 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.
The continuous wireless monitoring is 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 in the study was the plasma concentration of high-sensitive cardiac troponin T (hsTnT).
Myocardial injury
In this study, patients were divided into groups of myocardial injury, where patients had 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.
The continuous wireless monitoring is 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 in the study was the plasma concentration of high-sensitive cardiac troponin T (hsTnT).

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Frequency of patients with ST-deviation <-0.255 and/or >0.245 mV on single-lead ECG
Prazo: 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.
30 minutes

Medidas de resultados secundários

Medida de resultado
Prazo
Frequency of patients with significant ST-deviations <-0.1 and/or >0.1 mV lasting ≥ 1 minute.
Prazo: 1 minute
1 minute
Frequency of patients with significant ST-deviations <-0.1 and/or >0.1 mV lasting ≥ 10 minutes.
Prazo: 10 minutes
10 minutes
Frequency of patients with significant ST-deviations <-0.1 and/or >0.1 mV lasting ≥ 20 minutes.
Prazo: 20 minutes
20 minutes
Frequency of patients with significant ST-deviations <-0.1 and/or >0.1 mV lasting ≥ 30 minutes.
Prazo: 30 minutes
30 minutes
Frequency of patients with ST-deviation <-0.255 and/or >0.245 mV lasting ≥ 1 minute.
Prazo: 1 minute
1 minute
Frequency of patients with ST-deviation <-0.255 and/or >0.245 mV lasting ≥ 10 minutes.
Prazo: 10 minutes
10 minutes
Frequency of patients with ST-deviation <-0.255 and/or >0.245 mV lasting ≥ 20 minutes.
Prazo: 20 minutes
20 minutes
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.
Prazo: 3 days
3 days

Colaboradores e Investigadores

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Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

20 de fevereiro de 2018

Conclusão Primária (Real)

9 de junho de 2020

Conclusão do estudo (Real)

9 de junho de 2020

Datas de inscrição no estudo

Enviado pela primeira vez

10 de dezembro de 2021

Enviado pela primeira vez que atendeu aos critérios de CQ

10 de dezembro de 2021

Primeira postagem (Real)

29 de dezembro de 2021

Atualizações de registro de estudo

Última Atualização Postada (Real)

12 de janeiro de 2022

Última atualização enviada que atendeu aos critérios de controle de qualidade

3 de janeiro de 2022

Última verificação

1 de janeiro de 2022

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • ST-Deviation WARD

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Sim

produto fabricado e exportado dos EUA

Não

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