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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03081793
• Other study ID #: Wristheartrate
• Status: Completed
• Phase: N/A
• First received: March 10, 2017
• Last updated: September 18, 2017
• Start date: May 1, 2017
• Est. completion date: August 30, 2017

Study information

• Verified date: September 2017
• Source: Tampere University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 30, 2017
• Est. primary completion date: August 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
Finland	Tampere University Hospital	Tampere

Sponsors (2)

Lead Sponsor	Collaborator
Tampere University Hospital	PulseOn Ltd

Country where clinical trial is conducted

Finland, 

Outcome

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