Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 10:16 PM
Study NCT ID:
NCT04628858
Status:
COMPLETED
Last Update Posted:
2022-04-27
First Post:
2020-11-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Wireless Assessment of Respiratory and Circulatory Distress in Vascular Surgical Patients - An Observational Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Troponin-T'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2021-07-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-20', 'studyFirstSubmitDate': '2020-11-09', 'studyFirstSubmitQcDate': '2020-11-09', 'lastUpdatePostDateStruct': {'date': '2022-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Any serious adverse events', 'timeFrame': '30 days', 'description': 'In accordance with ICH-GCP: any untoward medical occurrence that(...)\n\n* Results in death\n* Is life-threatening\n* Requires inpatient hospitalization or causes prolongation of existing hospitalization\n* Results in persistent or significant disability/incapacity\n* Requires intervention to prevent permanent impairment or damage'}, {'measure': 'Readmission', 'timeFrame': '6 months'}, {'measure': 'ICU admission', 'timeFrame': '6 months'}, {'measure': 'Mortality', 'timeFrame': '6 months'}], 'primaryOutcomes': [{'measure': 'Physiologic abnormal vital signs - Cumulative duration', 'timeFrame': 'From inclusion until 4 days or discharge', 'description': 'Cumulative duration of physiologic vital signs within certain thresholds outside normalcy'}], 'secondaryOutcomes': [{'measure': 'Physiologic abnormal vital signs - Episodes of sustained duration', 'timeFrame': 'From inclusion until 4 days or discharge', 'description': 'Episodes of sustained duration of physiologic vital signs within certain thresholds outside normalcy, with different minimum durations'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Complication of Surgical Procedure', 'Complication of Anesthesia', 'Respiratory Complication', 'Circulatory; Complications']}, 'descriptionModule': {'briefSummary': "Vascular postsurgical patients have a high risk of morbidity and mortality. On top of that, patients undergoing vascular surgery usually have a high burden of comorbidities.\n\nAfter a short stay in the post-operative ward, patients are usually transferred to a standard surgical ward.\n\nMonitoring of physiological parameters by intermittent manual recordings 8-12 hours apart, is today's standard of care in hospitals. However, no effect on length of hospital stay, morbidity or mortality has been proven. This may be due to the up to 12 hours of unobserved time that can occur, where physiological deviations can progress resulting in clinical adverse outcomes such as myocardial infarction or stroke.\n\nVital sign micro events are occurrences when patient physiological parameters deviates significantly from what can be understood as normal physiology. Since adverse outcomes in patients rarely happens without deviating physiological parameters, it is to be investigated if micro events can be used to predict clinical adverse outcomes to patients. We acknowledge that during the observation period, the number of false alarms should be kept to a minimum to avoid the risk of 'alarm fatigue'"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '40 patients admitted for elective or subacute vascular surgical intervention, as noted in the inclusion criteria, will be included on the day before their surgical procedure.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients admitted to Copenhagen University Hospital\n* Patients with Peripheral Arteriel Disease(PAD)\n* Patients undergoing open infraligamentary revascularization\n* Emergency or subacute surgery\n* Admission the day before surgery, and expected length of stay more than 2 days.\n\nExclusion Criteria:\n\n* Patient expected not to cooperate\n* Patients with dementia or not able to give informed consent\n* Patient allergic to plaster, plastic or silicone\n* Patients with pacemaker or implantable cardioverter-defibrillator (ICD) unit\n* Patients in isolation\n* Active therapy withdrawn\n* Patients previously included in the other study branches\n* Patients with \\>20 mmHg in difference in systolic blood pressure between the two arms.\n* Expected discharge within less than 24 hours from possible inclusion'}, 'identificationModule': {'nctId': 'NCT04628858', 'acronym': 'WARD-VASC', 'briefTitle': 'Wireless Assessment of Respiratory and Circulatory Distress in Vascular Surgical Patients - An Observational Study', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Continuous Monitoring of Physiological Parameters for Early Detection of Complications in Postoperative Vascular Surgical Patients - An Observational Study', 'orgStudyIdInfo': {'id': 'H-19086583'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Primary group'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Eske K Aasvang', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Rigshospitalet, Denmark'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eske Kvanner Aasvang', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Dr. Med.', 'investigatorFullName': 'Eske Kvanner Aasvang', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}