Skip to main content
OpenTrials
Completed

NCT Number: NCT03081793

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tampere University Hospital

Tampere, 33521, Finland

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Recognition of the rhythm

    Time frame: 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 outcomes

  1. quantification of estimation errors

    Time frame: 2 hours

    To quantify the estimation errors of aforementioned parameters by comparing them to reference values obtained from the ECG

  2. identification of PPG morphology

    Time frame: 2 hours

    To quantify difference in morphological and other features calculated from the PPG signals collected from sinus-rhythm and AF patients

Sponsors and collaborators

Lead sponsor

Tampere University Hospital

Other

Collaborators

  • PulseOn Ltd

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 16, 2017
Registry last updated
Sep 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.