Estimation of Average and Beat-to-beat Heart Rate With a Novel Wrist-worn PPG Device in Surgery Patients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03081793

Enrollment

Registered

2017-03-16

Start date

2017-05-01

Completion date

2017-08-30

Last updated

2017-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

postoperative monitoring, plethysmography, monitoring

Brief summary

The aim of the study is to the reliability and feasibility of a novel optical heart rate monitor in hospital patients. Especially patients with atrial fibrillation are included. Patients will be monitored for two hours during routine post-operative care. The data from study device will be compared to routine monitoring. The design of the study is a Pilot feasibility study.

Detailed description

The primary use of photoplethysmography (PPG) measurement in clinical settings is usually the determination of the blood oxygen saturation level of the patient. The same device often reports also an average pulse rate of the subject. If the subject has low blood perfusion in the hands or suffers from acute atrial fibrillation, the determination of the pulse rate is challenging and therefore the readings provided by current technology are unreliable. Optical heart rate monitors (OHR) have recently become popular in sports and wellness applications and their performance in healthy subjects having normal blood perfusion in the extremities is well studied and documented and good accuracy has been shown healthy subjects. The performance of wrist-worn OHR monitors in hospital patients, however, has not been extensively studied. The aim of the study is to test novel wrist-worn photoplethysmographic (PPG) device in surgery patients and study its feasibility in detecting heart rate and beat to beat heart rate of patients having normal sinus rhythm or arrhythmia, such as atrial fibrillation (AF).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Age: \> 18 years * Subjected to surgery at Tampere University Hospital * Spontaneously ventilating * Volunteering for the study * Able to give a written informed consent

Exclusion criteria

* Having a cardiac pacemaker * Surgical operation performed in wrist area or any other reason that prevents placing the wrist-worn device in correct location * Neurological disease (e.g. Parkinson's) possibly causing notable amount of shivering * Non-Caucasian skin colour * Inability to give an informed consent * Denial of participation

Design outcomes

Primary

Measure	Time frame	Description
Recognition of the rhythm	2 hours	To verify that average heart rate (HR) and beat-to-beat heart rate estimation is reliable also with hospital patients having either normal sinus rhythm, atrial fibrillation, or other arrhythmia

Secondary

Measure	Time frame	Description
quantification of estimation errors	2 hours	To quantify the estimation errors of aforementioned parameters by comparing them to reference values obtained from the ECG
identification of PPG morphology	2 hours	To quantify difference in morphological and other features calculated from the PPG signals collected from sinus-rhythm and AF patients

Countries

Finland

Outcome results