Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2026-01-01 @ 8:56 AM
Study NCT ID:
NCT03944967
Status:
COMPLETED
Last Update Posted:
2023-11-21
First Post:
2019-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postoperative Remote Monitoring of Vital Signs in Older Cardiac Surgery Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000860', 'term': 'Hypoxia'}, {'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}], 'ancestors': [{'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2021-12-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-20', 'studyFirstSubmitDate': '2019-04-22', 'studyFirstSubmitQcDate': '2019-05-08', 'lastUpdatePostDateStruct': {'date': '2023-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hypoxemia', 'timeFrame': 'Three consecutive days after ICU discharge', 'description': 'Duration of sPO2 \\<80%, \\<85%, \\<90% and \\<95% in minutes per hour'}, {'measure': 'Respiratory deterioration', 'timeFrame': 'Three consecutive days after ICU discharge', 'description': 'Duration of respiratory rate \\<10 min-1, \\>20 min-1, \\>25 min-1, \\>30 min-1 in minutes per hour'}, {'measure': 'Arrythmia', 'timeFrame': 'Three consecutive days after ICU discharge', 'description': 'Duration of pulse rate \\<50 min-1, \\>100 min-1, \\>110 min-1, \\>120 min-1 in minutes per hour'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypoxemia', 'Respiratory Failure', 'Arrythmia']}, 'descriptionModule': {'briefSummary': 'A significant number of elderly patients experience a complication after cardiac surgery. This study aims to determine if postoperative remote monitoring of vital signs can be used to identify medicatie risk factors for vital sign deterioration in older cardiac surgery patients.\n\n* Single center pilot study.\n* 100 older patients undergoing cardiac surgery.\n* Continuous remote monitoring of vital signs after ICU discharge\n* Main study endpoint is vital sign deterioration.', 'detailedDescription': 'Cardiac surgery in elderly patients aims to improve functional capacity and overall survival but may also precipitate major morbidity and mortality. Despite major improvements in the safety of anesthesia and surgery a significant number of elderly patients experience a complication after cardiac surgery.\n\nTo determine if postoperative remote monitoring of vital signs can be used to identify medication risk factors for vital sign deterioration in older cardiac surgery patients..\n\n* Single center pilot study.\n* 100 older patients undergoing cardiac surgery.\n* Continuous remote monitoring of vital signs starts after ICU discharge\n* PR, RR and SpO2 will be continuously monitored in all patients.\n* Patients and healthcare personnel are blinded for monitoring results.\n* Main study endpoint is vital sign deterioration.\n\nThe study population includes 100 patients ≥70 years undergoing elective cardiac surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population includes 100 patients ≥70 years undergoing elective cardiac surgery.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥70 years undergoing elective cardiac surgery.\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03944967', 'acronym': 'AGEAWARE', 'briefTitle': 'Postoperative Remote Monitoring of Vital Signs in Older Cardiac Surgery Patients', 'organization': {'class': 'OTHER', 'fullName': 'St. Antonius Hospital'}, 'officialTitle': 'Postoperative Remote Monitoring of Vital Signs in Older Cardiac Surgery Patients', 'orgStudyIdInfo': {'id': 'NL68944.100.19'}}, 'contactsLocationsModule': {'locations': [{'zip': '3435 CM', 'city': 'Nieuwegein', 'state': 'Utrecht', 'country': 'Netherlands', 'facility': 'St Antonius hospital', 'geoPoint': {'lat': 52.02917, 'lon': 5.08056}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'St. Antonius Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PI', 'investigatorFullName': 'dr. P. Noordzij', 'investigatorAffiliation': 'St. Antonius Hospital'}}}}