Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2025-12-24 @ 2:44 PM
Study NCT ID:
NCT02908659
Status:
COMPLETED
Last Update Posted:
2018-02-01
First Post:
2016-09-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Relevance and Nuisances of Respiratory Rate Alarm Generated by Multi-parametric Monitors in Non Ventilated ICU Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 122}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2017-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-31', 'studyFirstSubmitDate': '2016-09-07', 'studyFirstSubmitQcDate': '2016-09-16', 'lastUpdatePostDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of useful alarms within 2000 patient-monitored hours', 'timeFrame': 'through study completion, within 6 months', 'description': 'Number of intervention of healthcare team following a relevant respiratory rate alarm generated by a monitoring device and without any other associated alarm.'}], 'secondaryOutcomes': [{'measure': 'Ratio of artifact alarms among all alarms generated by the monitoring device', 'timeFrame': 'through study completion within 6 months', 'description': 'Artifact alarm : monitoring is functional but the measure is false'}, {'measure': 'Ratio of technical alarms among all alarms generated by the monitoring device', 'timeFrame': 'through study completion within 6 months', 'description': 'Technical alarm : Alarm leading to a reactivation of the monitoring system.'}, {'measure': 'Ratio of significant alarms among all alarms generated by the monitoring device', 'timeFrame': 'through study completion within 6 months', 'description': 'Significant alarm: True alarm triggered by a correct measure'}, {'measure': 'Number of care activity interrupted by a respiratory rate alarm generated by the monitoring device', 'timeFrame': 'through study completion within 6 months'}, {'measure': 'Setting of alarms on the monitoring device', 'timeFrame': 'through study completion within 6 months'}, {'measure': 'ICU length of stay', 'timeFrame': 'Until discharge from ICU, an expected average of 7 days'}, {'measure': 'all-cause ICU mortality', 'timeFrame': 'Until discharge from ICU, an expected average of 7 days ]'}, {'measure': 'Ratio of respiratory rate alarms generated by the monitoring device among all ICU alarms', 'timeFrame': 'through study completion within 6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['intensive care unit', "patient's monitoring", 'respiratory rate'], 'conditions': ['Non Ventilated ICU Patients']}, 'descriptionModule': {'briefSummary': 'In ICU setting, a large number of medical devices are attached to patients, generating numerous alarm signals. Several studies have demonstrated that most of these alarms are not clinically relevant and tend to lower the attentiveness of healthcare professional and, in turn, lower patient safety.The aim of the study is to assess the relevance of respiratory rate alarm on a monitoring device in non-ventilated ICU patients.\n\nThe investigator primary hypothesis is that this alarm is potentially useless. If this hypothesis is confirmed, a second interventional trial will be conducted on the impact of this alarm removal.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admitted to ICU unit at La Roche sur yon Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age over 18 years\n* Patient hospitalized in ICU\n* Need for monitoring\n\nExclusion Criteria:\n\n* Invasive mechanical ventilation\n* Non-invasive mechanical ventilation\n* Patient not monitored\n* Patient already included in this study\n* Patient hospitalized without consent and/or deprived of liberty by court's decision\n* Patient under guardianship or curators\n* Lack of social insurance\n* Patient's or next of kin's refusal"}, 'identificationModule': {'nctId': 'NCT02908659', 'acronym': 'FR-REA', 'briefTitle': 'Relevance and Nuisances of Respiratory Rate Alarm Generated by Multi-parametric Monitors in Non Ventilated ICU Patients', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Departemental Vendee'}, 'officialTitle': 'Relevance and Possible Nuisances of Respiratory Rate Alarm Generated by Multi-parametric Monitors in Non Ventilated ICU Patients.A Prospective, Monocentric, Observational Study', 'orgStudyIdInfo': {'id': 'CHD 087-16'}}, 'contactsLocationsModule': {'locations': [{'zip': '85000', 'city': 'La Roche-sur-Yon', 'country': 'France', 'facility': 'CHD Vendee', 'geoPoint': {'lat': 46.66974, 'lon': -1.42757}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Departemental Vendee', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}