Photoplethysmography to detect circulatory arrest: A study in patients with induced cardiac arrest

Recruiting

Conditions: hartstilstand
Cardiac arrest
10019280

Registration Number: NL-OMON51869

Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 207

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet one
of the following
criteria:
- Undergoing ventricular fibrillation induction during defibrillation testing
after ICD
implantation
- Undergoing rapid ventricular pacing during TAVR procedure
- Undergoing ventricular tachycardia ablation
Additionally, a subject must meet all of the following criteria:
- Age => 18 years
- Fitting the wristband

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded
from
participation in this study:
- Unwilling or unable to provide informed consent
- Known hemodynamically relevant subclavian artery stenosis
- Medical issues that interfere with wearing of the wristband (e.g. skin
disorders)
- Unavailability of wristband used for PPG recording

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Sensitivity and specificity of the developed algorithm for circulatory arrest<br /><br>detection</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Positive predictive value of the developed algorithm for circulatory arrest<br /><br>detection<br /><br>- Negative predictive value of the developed algorithm for circulatory arrest<br /><br>detection<br /><br>- PPG-derived signal characteristics during circulatory and non-circulatory<br /><br>arrest<br /><br>- Sources of noise<br /><br>- Sources of false positive alarms<br /><br>- Patient satisfaction scores<br /><br>- Complaints regarding the fit of the wristband<br /><br>- Correlation and agreement of heart rate measurements<br /><br>- Correlation and agreement of oxygen saturation measurements<br /><br>- Correlation and agreement of blood pressure measurements</p><br>