Atrial FibrillationNCT03081793
Estimation of Average and Beat-to-beat Heart Rate With a Novel Wrist-worn PPG Device in Surgery Patients
An observational study of Atrial Fibrillation, run by Tampere University Hospital at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 30 participants
- Where
- 1 siteFinland
- Study dates
- 1 May 2017to 30 Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients subjected to surgery requiring post-operative care. A heterogenous sample of patients with atrial fibrillation and patients with sinus rhytm
Who may be able to join
- Age: > 18 years
- Subjected to surgery at Tampere University Hospital
- Spontaneously ventilating
- Volunteering for the study
- Able to give a written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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).
- Conditions
- Atrial Fibrillation
- Keywords
- postoperative monitoring, plethysmography, monitoring
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with sinus Rhythm | Patients with sinus rhythm at the beginning of monitoring | |
| Atrial fibrillation | Patients with atrial fibrillation at the beginning of monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 hours
Secondary outcomes (2)
quantification of estimation errors
To quantify the estimation errors of aforementioned parameters by comparing them to reference values obtained from the ECG
Measured: 2 hours
identification of PPG morphology
To quantify difference in morphological and other features calculated from the PPG signals collected from sinus-rhythm and AF patients
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2017
- Study start1 May 2017
- Primary completion30 Aug 2017
- Study completion30 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- PulseOn Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03081793
- Sponsor's protocol ID
- Wristheartrate
- Status last verified
- Sep 2017
- First submitted
- 10 Mar 2017
- Last updated
- 19 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimation of Average and Beat-to-beat Heart Rate With a Novel Wrist-worn PPG Device in Surgery Patients
- ClinicalTrials.gov ID
- NCT03081793
- Acronym / sponsor ID
- Wristheartrate
- Conditions
- Atrial Fibrillation
- Keywords
- postoperative monitoring, plethysmography, monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Collaborators
- PulseOn Ltd
- Study start
- 1 May 2017 (actual)
- Primary completion
- 30 Aug 2017 (actual)
- Study completion
- 30 Aug 2017 (actual)
- First posted
- 16 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with sinus Rhythm | – | –Patients with sinus rhythm at the beginning of monitoring |
| Atrial fibrillation | – | –Patients with atrial fibrillation at the beginning of monitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients subjected to surgery requiring post-operative care. A heterogenous sample of patients with atrial fibrillation and patients with sinus rhytm
Key inclusion criteria (5 listed)
- Age: > 18 years
- Subjected to surgery at Tampere University Hospital
- Spontaneously ventilating
- Volunteering for the study
- Able to give a written informed consent
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
quantification of estimation errors
Time frame: 2 hours
identification of PPG morphology
Time frame: 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Tampere University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recognition of the rhythm (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2017.