Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2026-03-03 @ 12:02 AM
Study NCT ID:
NCT03750318
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-10-09
First Post:
2018-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation Study on RENEW's Aingeal at KK Women's and Children's Hospital
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-04-03', 'size': 957853, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-11-12T01:33', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'All patients recruited will be wearing the Aingeal device as part of an integrated monitoring with opioid delivery system at ward setting.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-08', 'studyFirstSubmitDate': '2018-11-20', 'studyFirstSubmitQcDate': '2018-11-20', 'lastUpdatePostDateStruct': {'date': '2024-10-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Respiratory alarm rate per patient per day', 'timeFrame': '3-4 days (upon admission till 1-3 days after surgery)', 'description': 'De-identified log files will be extracted from the Surveillance Station and reprocessed to produce counts of the number of respiratory alarms raised during monitoring. A sample of the data will be reviewed against the nursing chart to determine whether respiratory alarms are defined as True or False, with an overall Alarm Rate per patient per day derived.'}], 'secondaryOutcomes': [{'measure': 'Overall Cardiac alarm rate per patient per day', 'timeFrame': '3-4 days (upon admission till 1-3 days after surgery)', 'description': 'De-identified log files will be extracted from the Surveillance Station and reprocessed to produce counts of the number of cardiac alarms raised during monitoring. A sample of the data will be reviewed against the nursing chart to determine whether cardiac alarms are defined as True or False, with an overall Alarm Rate per patient per day derived.'}, {'measure': 'False positive Respiratory alarm rate per patient per day', 'timeFrame': '3-4 days (upon admission till 1-3 days after surgery)', 'description': 'De-identified log files will be extracted from the Surveillance Station and reprocessed to produce counts of the number of respiratory alarms raised during monitoring. A sample of the data will be reviewed against the nursing chart to determine whether respiratory alarms are defined as True or False, with False Positive Alarm Rate per patient per day derived.'}, {'measure': 'False positive Cardiac alarm rate per patient per day', 'timeFrame': '3-4 days (upon admission till 1-3 days after surgery)', 'description': 'De-identified log files will be extracted from the Surveillance Station and reprocessed to produce counts of the number of cardiac alarms raised during monitoring. A sample of the data will be reviewed against the nursing chart to determine whether cardiac alarms are defined as True or False, with False Positive Alarm Rate per patient per day derived.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vital sign monitoring', 'Heart rate', 'Respiratory rate'], 'conditions': ['Vital Sign', 'Heart Rate', 'Respiratory Rate']}, 'descriptionModule': {'briefSummary': 'This proposal describes the evaluation of a CE-marked, FDA cleared vital signs Surveillance Monitoring system within an adult in-patient setting KK Women\'s and Children\'s Hospital ("KKH"), the main tertiary women and children hospital in Singapore. User acceptance of Aingeal and the Surveillance System will be considered within the clinical settings.', 'detailedDescription': 'RENEW\'s Surveillance Monitoring system is made up of two main components: a patient-worn wireless vital signs monitor (Aingeal) that transmits data over Wi-Fi to a central station software platform (Surveillance Station). The Aingeal device measures single lead ECG, heart rate, respiration waveform and rate, and skin temperature. A snapshot of data is transmitted by the devices intermittently to the Surveillance Station, enabling vital signs trends to be plotted. If any heart, respiration rate or skin temperature values move outside of pre-defined high and low limits (individually set for each patient) an alert is raised. ECG arrhythmia detection algorithms automatically record and send ECG data if the patient is suspected to be experiencing an arrhythmia event (Asystole, Ventricular Fibrillation, Tachycardia or Bradycardia). This proposal describes the evaluation of RENEW\'s Aingeal device within an adult in-patient setting KK Women\'s and Children\'s Hospital ("KKH"), the main tertiary women and children hospital in Singapore. User acceptance of Aingeal and the Surveillance System will be considered within the clinical settings.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '21 Years', 'genderBased': True, 'genderDescription': 'Only women receiving gynaecological surgery in the mentioned hospital will be recruited.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult female patients, aged 21 years or over\n* Patients admitted to post-operative gynaecological ward at KKH Women's and Children's Hospital, Singapore\n* Patients receiving opioid therapy via patient controlled analgesia (PCA)\n* Patients that are on electronic nursing charting\n* Patients that are on acute pain service monitoring\n\nExclusion Criteria:\n\n* Patients with active, implantable devices (such as a pacemaker or ICD)\n* Patients with any skin condition or injury affecting the electrode placement site\n* Patients that are pregnant (Heart Rate detection algorithm has not been designed to reject foetal heart rate)"}, 'identificationModule': {'nctId': 'NCT03750318', 'acronym': 'RENEW', 'briefTitle': "Validation Study on RENEW's Aingeal at KK Women's and Children's Hospital", 'organization': {'class': 'OTHER_GOV', 'fullName': "KK Women's and Children's Hospital"}, 'officialTitle': "Validation Study on RENEW's Aingeal at KK Women's and Children's Hospital", 'orgStudyIdInfo': {'id': '2018/2223 (Women)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aingeal', 'description': 'All patients will wear the Aingeal device as part of the vital sign monitoring with opioid delivery system at ward setting.', 'interventionNames': ['Device: Vital sign monitoring']}], 'interventions': [{'name': 'Vital sign monitoring', 'type': 'DEVICE', 'description': 'Each patient will be set up for monitoring on admission. Duration of opioid therapy for post-operative in-patients may range from 1-3 days. Once opioid therapy is no longer required, Aingeal monitoring will be ended and each patient would be encouraged to have at least 1 day Aingeal monitoring to be recorded during the study. De-identified log files will be extracted from the Surveillance Station and reprocessed to produce counts of the number of alarms raised during monitoring. A sample of the data will be reviewed to determine whether cardiac and respiratory alarms are defined as True or False, with an overall Alarm Rate per patient per day and False Positive Alarm Rate per patient per day derived. Vital sign trend graphs for each patient will be produced.', 'armGroupLabels': ['Aingeal']}]}, 'contactsLocationsModule': {'locations': [{'zip': '229899', 'city': 'Singapore', 'country': 'Singapore', 'facility': "KK Women's and Children's Hospital", 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'overallOfficials': [{'name': 'Ban Leong Sng, FANZCA', 'role': 'STUDY_DIRECTOR', 'affiliation': "KK Women's and Children's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "KK Women's and Children's Hospital", 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Renew Group', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "Head and Senior Consultant, Dept of Women's Anaesthesia", 'investigatorFullName': 'Sng Ban Leong', 'investigatorAffiliation': "KK Women's and Children's Hospital"}}}}