Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2026-01-06 @ 5:43 PM
Study NCT ID:
NCT04119193
Status:
COMPLETED
Last Update Posted:
2019-12-11
First Post:
2019-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Agreement and Precision of a Smartphone Application For Continuous Blood Pressure Monitoring
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001795', 'term': 'Blood Pressure Determination'}], 'ancestors': [{'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D010808', 'term': 'Physical Examination'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2019-12-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-10', 'studyFirstSubmitDate': '2019-10-05', 'studyFirstSubmitQcDate': '2019-10-05', 'lastUpdatePostDateStruct': {'date': '2019-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of blood pressure measurement done with the novel smartphone application versus the reference method', 'timeFrame': 'Day of surgery', 'description': 'Comparison of values to invasive reference method (arterial line)'}], 'secondaryOutcomes': [{'measure': 'Number of necessary measure to have a good relationship between both methods', 'timeFrame': 'Day of surgery', 'description': 'Number of necessary measure to have a good relationship between both methods'}, {'measure': 'Usability assessment', 'timeFrame': 'Day of surgery', 'description': 'Identification of possible use error in the manipulation of the device and in the performance of the measure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Technology']}, 'descriptionModule': {'briefSummary': 'Evaluation of an novel smartphone algorithm designed to estimate blood pressure based on collected optical signals on patients against the reference method, (radial arterial catheter) in patients admitted in the post anesthesia care unit after major surgeries.', 'detailedDescription': "The purpose of the study is to compare the blood pressure values measured by a mobile application used with a smartphone and the values measured by reference method, which is the radial arterial line\n\nPatients admitted to the post-anesthesia care unit after major surgeries (Erasme hospital)\n\nPatient's arterial pressure will be measured with both measurement methods (novel smartphone application and the invasive arterial line).\n\nThe placement of an arterial line is standard of care in the investigators institution for patients scheduled for major surgeries. These patients spend 24 hours in the post-anesthesia care unit after their surgery for acute care management. Patient's blood pressure will be measured in parallel (same arm) with the mobile application and with the reference equipment (radial arterial line). Measures will be done during five times ( so five times one minute of recordings).\n\nBlood pressure values obtained by the two methods will be compared to confirm the reliability of the data obtained with the mobile application."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients in the post-anesthesia care unit after their major surgery, equipped with an arterial line', 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult patients in the post-anesthesia care unit after major surgery\n* equipped with an arterial catheters for perioperative management\n* Informed Consent as documented by signature\n* Good understanding of written and oral speaking\n\nExclusion Criteria:\n\n* Patients that cannot sign informed consent\n* Patients in emergency situation, are not legally competent, cannot understand the situation\n* Known contact dermatitis to nickel/chromium\n* Dyshythmia like bigeminy, trigeminy, isolated Ventricular Premature Beats (VPB), atrial fibrillation\n* Lesion or deficiency on hand, preventing index obstruction of smartphone's camera"}, 'identificationModule': {'nctId': 'NCT04119193', 'briefTitle': 'Agreement and Precision of a Smartphone Application For Continuous Blood Pressure Monitoring', 'organization': {'class': 'OTHER', 'fullName': 'Erasme University Hospital'}, 'officialTitle': 'Agreement and Precision of a Novel Smartphone Application (OPTIBP) For Continuous Blood Pressure Monitoring: A Comparison With the Invasive Radial Arterial Catheter', 'orgStudyIdInfo': {'id': '2019-375'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Novel smartphone application for blood pressure measurement', 'type': 'DEVICE', 'description': 'Continuous blood pressure measurements will be compared between the new application and the reference method (invasive radial arterial line) during 5 minutes of recordings.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1070', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Erasme', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'overallOfficials': [{'name': 'Alexandre J Joosten, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ERASME'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Erasme University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Alexandre Joosten, MD PhD', 'investigatorAffiliation': 'Erasme University Hospital'}}}}