Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2026-01-02 @ 10:19 PM
Study NCT ID:
NCT03081793
Status:
COMPLETED
Last Update Posted:
2017-09-19
First Post:
2017-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Estimation of Average and Beat-to-beat Heart Rate With a Novel Wrist-worn PPG Device in Surgery Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2017-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-18', 'studyFirstSubmitDate': '2017-03-10', 'studyFirstSubmitQcDate': '2017-03-10', 'lastUpdatePostDateStruct': {'date': '2017-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recognition of the rhythm', 'timeFrame': '2 hours', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'quantification of estimation errors', 'timeFrame': '2 hours', 'description': 'To quantify the estimation errors of aforementioned parameters by comparing them to reference values obtained from the ECG'}, {'measure': 'identification of PPG morphology', 'timeFrame': '2 hours', 'description': 'To quantify difference in morphological and other features calculated from the PPG signals collected from sinus-rhythm and AF patients'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['postoperative monitoring', 'plethysmography', 'monitoring'], 'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nIf 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.\n\nOptical 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.\n\nThe 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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients subjected to surgery requiring post-operative care. A heterogenous sample of patients with atrial fibrillation and patients with sinus rhytm', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age: \\> 18 years\n* Subjected to surgery at Tampere University Hospital\n* Spontaneously ventilating\n* Volunteering for the study\n* Able to give a written informed consent\n\nExclusion Criteria:\n\n* Having a cardiac pacemaker\n* Surgical operation performed in wrist area or any other reason that prevents placing the wrist-worn device in correct location\n* Neurological disease (e.g. Parkinson's) possibly causing notable amount of shivering\n* Non-Caucasian skin colour\n* Inability to give an informed consent\n* Denial of participation"}, 'identificationModule': {'nctId': 'NCT03081793', 'briefTitle': 'Estimation of Average and Beat-to-beat Heart Rate With a Novel Wrist-worn PPG Device in Surgery Patients', 'organization': {'class': 'OTHER', 'fullName': 'Tampere University Hospital'}, 'officialTitle': 'Estimation of Average and Beat-to-beat Heart Rate With a Novel Wrist-worn PPG Device in Surgery Patients', 'orgStudyIdInfo': {'id': 'Wristheartrate'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with sinus Rhythm', 'description': 'Patients with sinus rhythm at the beginning of monitoring'}, {'label': 'Atrial fibrillation', 'description': 'Patients with atrial fibrillation at the beginning of monitoring'}]}, 'contactsLocationsModule': {'locations': [{'zip': '33521', 'city': 'Tampere', 'country': 'Finland', 'facility': 'Tampere University Hospital', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tampere University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'PulseOn Ltd', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}