Ignite Creation Date:
2025-12-26 @ 10:33 AM
Ignite Modification Date:
2026-03-05 @ 2:20 PM
Study NCT ID:
NCT02427828
Status:
COMPLETED
Last Update Posted:
2015-04-28
First Post:
2013-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
VRES Study in Two Phases to Monitor Cardiac Surgical Patients Following Discharge From ICU
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 208}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-27', 'studyFirstSubmitDate': '2013-11-05', 'studyFirstSubmitQcDate': '2015-04-27', 'lastUpdatePostDateStruct': {'date': '2015-04-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of ward cardiac arrests', 'timeFrame': 'Up to 72hours', 'description': 'Duration of acute hospital stay'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Surgical Procedure, Unspecified']}, 'descriptionModule': {'briefSummary': "Failure to recognise deterioration early is a major cause of preventable deaths amongst hospital patients. The investigators wish to study whether continuous monitoring of 'vital signs' (pulse rate, breathing rate, and blood oxygen saturations) with computer modeled alerting to detect patient deteriorations can reduce cardiac arrest rate and critical care readmissions from the wards by alerting staff to clinical deteriorations more effectively than current paperbased systems.\n\nContinuous monitoring of 'vital signs' can be achieved in two ways. Continuous monitoring of 'vital signs' has traditionally been restricted to the bedside because of the need for the patient to be connected by wires to the monitor.\n\nMore recently, advances in telemetry (wireless technology) have allowed the development of wearable devices which allow patients to mobilise freely, whilst constantly monitoring these 'vital signs'."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients admitted to the Papworth Hospital NHS Foundation Trust for routine cardiovascular surgery and who are discharged from ICU into the study ward (Mallard).\n\nExclusion Criteria:\n\n* transplant surgery patients,\n* VAD patients,\n* children (less than 18 years old),\n* prisoners (due to constant observation/security may bias normal level of care),\n* patients who are subject to additional protections: this includes pregnant women, and persons with mental illness and learning disabilities,\n* patients whose anatomy precludes the use of the required monitoring,\n* patients who cannot understand written English (and where no translator is available),\n* patients who are unable to give consent themselves,\n* patients with learning difficulties who cannot understand the information to consent for themselves.'}, 'identificationModule': {'nctId': 'NCT02427828', 'acronym': 'VRES', 'briefTitle': 'VRES Study in Two Phases to Monitor Cardiac Surgical Patients Following Discharge From ICU', 'organization': {'class': 'INDUSTRY', 'fullName': 'OBS Medical Ltd'}, 'officialTitle': 'Continuous, Ambulatory, Non Invasive, Vital Sign Monitoring Using VRES of Cardiac Surgical Patients Following Discharge From Intensive Care. Impact on Detection of Physiological Deterioration', 'orgStudyIdInfo': {'id': '011-0216-OTH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment Group', 'description': 'Assessment of Visensia Respiration Rate Estimation Service (product) to provide Respiration Rate from PPG signal, providing 3 vital signs (heart rate, oxygen saturation and respiration rate) to facilitate continuous Safety Index (VSI) calculation by Visensia, alongside standard routine intermittent observations (vital signs every 4 - 6 hours).', 'interventionNames': ['Device: Visensia Respiration Rate Estimation Service (VRES)']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Using standard routine intermittent observation (vital signs every 4 - 6 hours) and calculation of NEWS/MEWS scores for early detection of patient deterioration.'}], 'interventions': [{'name': 'Visensia Respiration Rate Estimation Service (VRES)', 'type': 'DEVICE', 'description': 'Medical device product to provide respiration rate from PPG signal', 'armGroupLabels': ['Treatment Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Papworth Everard', 'state': 'Cambridgeshire', 'country': 'United Kingdom', 'facility': 'Papworth Hospital', 'geoPoint': {'lat': 52.24893, 'lon': -0.11827}}], 'overallOfficials': [{'name': 'John Mackay', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Papworth Hospital NHS Foundation Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'OBS Medical Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}