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

3 janvier 2022 mis à jour par: 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.

Aperçu de l'étude

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Réel)

698

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
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).

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Frequency of patients with ST-deviation <-0.255 and/or >0.245 mV on single-lead ECG
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Délai
Frequency of patients with significant ST-deviations <-0.1 and/or >0.1 mV lasting ≥ 1 minute.
Délai: 1 minute
1 minute
Frequency of patients with significant ST-deviations <-0.1 and/or >0.1 mV lasting ≥ 10 minutes.
Délai: 10 minutes
10 minutes
Frequency of patients with significant ST-deviations <-0.1 and/or >0.1 mV lasting ≥ 20 minutes.
Délai: 20 minutes
20 minutes
Frequency of patients with significant ST-deviations <-0.1 and/or >0.1 mV lasting ≥ 30 minutes.
Délai: 30 minutes
30 minutes
Frequency of patients with ST-deviation <-0.255 and/or >0.245 mV lasting ≥ 1 minute.
Délai: 1 minute
1 minute
Frequency of patients with ST-deviation <-0.255 and/or >0.245 mV lasting ≥ 10 minutes.
Délai: 10 minutes
10 minutes
Frequency of patients with ST-deviation <-0.255 and/or >0.245 mV lasting ≥ 20 minutes.
Délai: 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.
Délai: 3 days
3 days

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

20 février 2018

Achèvement primaire (Réel)

9 juin 2020

Achèvement de l'étude (Réel)

9 juin 2020

Dates d'inscription aux études

Première soumission

10 décembre 2021

Première soumission répondant aux critères de contrôle qualité

10 décembre 2021

Première publication (Réel)

29 décembre 2021

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

12 janvier 2022

Dernière mise à jour soumise répondant aux critères de contrôle qualité

3 janvier 2022

Dernière vérification

1 janvier 2022

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • ST-Deviation WARD

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Oui

produit fabriqué et exporté des États-Unis.

Non

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