Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2025-12-29 @ 5:04 AM
Study NCT ID:
NCT04055350
Status:
UNKNOWN
Last Update Posted:
2021-12-21
First Post:
2019-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Electronically Recorded National Early Warning Scores, Pain Scores and PONV Scores Among Hospitalized 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': 30000}, 'targetDuration': '90 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-12-05', 'studyFirstSubmitDate': '2019-08-05', 'studyFirstSubmitQcDate': '2019-08-12', 'lastUpdatePostDateStruct': {'date': '2021-12-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Death occurring within 90-days of the last NEWS measurement', 'timeFrame': '90 days', 'description': 'The percentage of patients that die within 90-days of the last NEWS recording during their hospitalization.'}, {'measure': 'Death occurring within one day after the first NEWS measurement on general wards', 'timeFrame': 'One day', 'description': 'The percentage of patients that die within one day after their first NEWS measurement at the beginning of their general ward admission'}], 'secondaryOutcomes': [{'measure': 'Death occurring within 30-days of the last NEWS measurement', 'timeFrame': '30 days', 'description': 'The percentage of patients that die within 30-days of the last NEWS recording during their hospitalization.'}, {'measure': 'Death occurring within 2-30 days after the first NEWS measurement on general wards', 'timeFrame': '2-30 days', 'description': 'The percentage of patients that die within 2-30 days after their first NEWS measurement at the beginning of their general ward admission'}, {'measure': 'Incidence of post operative nausea and vomiting', 'timeFrame': "Up to 30 days after the first recording of patient's vital signs in the electronic patient records", 'description': 'Percentage of patients suffering from post-operative nausea and vomiting (recorded as a scale from 0 to 5) in the electronic patient records.'}, {'measure': 'Incidence of post operative pain', 'timeFrame': "Up to 30 days after the first recording of patient's vital signs in the electronic patient records", 'description': 'Percentage of patients suffering from post operative pain (recorded as numerical scale from 0 to 10) in the electronic patient records.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['National early warning score', 'Prevention of serious adverse events', 'Patient deterioration'], 'conditions': ['Prevention of In-hospital Adverse Events']}, 'referencesModule': {'references': [{'pmid': '35473725', 'type': 'DERIVED', 'citation': 'Loisa E, Kallonen A, Hoppu S, Tirkkonen J. Ability of the National Early Warning Score and its respiratory and haemodynamic subcomponents to predict short-term mortality on general wards: a prospective three-centre observational study in Finland. BMJ Open. 2022 Apr 26;12(4):e055752. doi: 10.1136/bmjopen-2021-055752.'}]}, 'descriptionModule': {'briefSummary': 'National early warning score (NEWS) enables early detection of patient deterioration in hospital floors. However, there is limited data on the prognostic value of NEWS among actual general ward patients. Further, there is no data on how changes in NEWS-values impact patient outcomes. Very little is known on how post-operative nausea and vomiting (PONV) and pain influences NEWS values and vital signs in general.', 'detailedDescription': "The investigators aim to collect detailed data on patients' vital signs, NEWSs, pain scores and PONV scores through electronic data records, where these values are automatically stored with mobile mobile smart devices used by nursing staff. The expected volume of the cohort is 50,000 patients and 300,000 recordings of vital signs.\n\nIn addition to the scores and vital signs, the registry will include patients' identification numbers (IDs), dates and times of the recordings, and ward numbers. With the IDs, mortality data up to 90-days for the patients will be obtained from the national population register centre. All data will be handled in a pseudonymized form in a secure computer inside hospital, and approval to use the registry in study purposes will be obtained from the Ethics Committee of Tampere University Hospital."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult in-hospital patients in Pirkanmaa Hospital District whose vital signs have been recorded with mobile smart devices during the study period.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult in-hospital patients with recordings of vital signs\n\nExclusion Criteria:\n\n* Patients under 18 years'}, 'identificationModule': {'nctId': 'NCT04055350', 'briefTitle': 'Electronically Recorded National Early Warning Scores, Pain Scores and PONV Scores Among Hospitalized Patients', 'organization': {'class': 'OTHER', 'fullName': 'Tampere University Hospital'}, 'officialTitle': 'Electronically Recorded National Early Warning Scores, Pain Scores and PONV Scores Among Hospitalized Patients and the Associated Patient Outcomes.', 'orgStudyIdInfo': {'id': 'R20007R'}}, 'contactsLocationsModule': {'locations': [{'zip': '33520', 'city': 'Tampere', 'state': 'Pirkanmaa', 'country': 'Finland', 'facility': 'Tampere University Hospital', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Due to data security policies, individual participant data will not be shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tampere University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD. Resident in Anaesthesiology and Intensive Care Medicine. Principal Investigator in this Study.', 'investigatorFullName': 'Joonas Tirkkonen', 'investigatorAffiliation': 'Tampere University Hospital'}}}}