Clinical trial NCT03081793: Estimation of Average and Beat-to-beat Heart Rate With a Novel Wrist-worn PPG Device in Surgery Patients
Official title: Estimation of Average and Beat-to-beat Heart Rate With a Novel Wrist-worn PPG Device in Surgery Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: postoperative monitoring
plethysmography
monitoring
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
Collaborators: name: PulseOn Ltd
First posted: 2017-03-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients subjected to surgery requiring post-operative care. A heterogenous sample of patients with atrial fibrillation and patients with sinus rhytm

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).

Eligibility criteria: 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

Primary outcomes:
measure: Recognition of the rhythm
timeFrame: 2 hours
Secondary outcomes:
measure: quantification of estimation errors
timeFrame: 2 hours
measure: identification of PPG morphology
timeFrame: 2 hours
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
Study officials:
References: