Clinical trial NCT04374344: Qualitative Analysis of Photoplethysmography Waveforms for the Detection of Cardiac Arrhythmias
Official title: Qualitative Analysis of Photoplethysmography Waveforms for the Detection of Cardiac Arrhythmias Using a Pulse-deriving Smartphone Application
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Arrhythmia
Keywords: Qualitative analysis
Photoplethysmography
Single-lead electrocardiography
Lead sponsor: Qompium NV
Sponsor class: INDUSTRY
First posted: 2020-05-05
Enrollment: 76
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Medical professionals including cardiologists and cardiology residents with and without experience in qualitative analysis of PPG waveforms.

Brief summary: Single-lead electrocardiography (ECG) technologies and photoplethysmography (PPG) deriving smartphone apps are gaining interest in the heart rhythm detection space since these apps have the potential to capture and assess heart rhythms. Proprietary arrhythmia detection algorithms are proven to be reliable and accurate. However, insights into the readability of PPG waveforms by human reviewers remain limited. To the investigators' knowledge, there are no publications available regarding the readability of PPG waveforms by human reviewers. The objective of the study was to assess the readability of PPG and single-lead ECG analysis by medical professionals, with respect to the gold-standard 12-lead ECG diagnosis, and investigate whether additional information positively impacts PPG analysis.

Detailed description: During the study, the readability of PPG and single-lead ECG waveform analysis will be investigated. The objective of the study is to determine the readability of PPG and single-lead ECG measurements, with respect to the gold-standard 12-lead ECG, and investigate whether additional information positively impacts the readability of PPG. Medical professionals (cardiologists and cardiology residents), blinded for the patients' characteristics and history, are instructed to separately analyse the following signals, obtained from 30 patients.

* 30 outputs with PPG waveforms
* 30 outputs with PPG waveforms with tachogram and Poincaré
* 30 outputs with PPG waveforms with tachogram, Poincaré, and algorithm interpretation
* 30 outputs with single-lead ECG waveforms
* 30 outputs with 12-lead ECG waveforms

Participants report the results of the qualitative analysis via a digital questionnaire with multiple-choice questions. Medical professionals classify each rhythm trace as regular rhythm, one or more ectopic/missed heartbeats, atrial flutter, atrial fibrillation, unreadable, or other. The tachogram, Poincaré, and the algorithm interpretation are subsequently added to investigate whether the additional information improves the readability of PPG. Based on the provided answers, the study team will determine the readability of PPG and single-lead ECG analysis interpretation, with respect to the gold-standard 12-lead ECG diagnosis.

Eligibility criteria: Inclusion Criteria:

* Cardiologist or cardiology resident
* Able to understand Dutch or English

Primary outcomes:
measure: Diagnostic accuracy to discriminate between atrial fibrillation and non-atrial fibrillation rhythms
timeFrame: Through study completion, an average of 3 months
Secondary outcomes:
measure: Required elements to increase the readability of PPG measurements
timeFrame: Through study completion, an average of 3 months
measure: Diagnostic accuracy of PPG analysis: experienced in PPG analysis vs inexperienced in PPG analysis
timeFrame: Through study completion, an average of 3 months
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost Limburg
state: Limburg
Study officials:
affiliation: Ziekenhuis Oost-Limburg
name: Pieter Vandervoort, MD
role: PRINCIPAL_INVESTIGATOR
References: