Ignite Creation Date:
2025-12-25 @ 12:54 AM
Ignite Modification Date:
2025-12-28 @ 5:14 PM
Study NCT ID:
NCT05092867
Status:
COMPLETED
Last Update Posted:
2021-10-26
First Post:
2021-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reliability and Validity of a New Postoperative Track Assessment Tool
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': 879}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2020-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-12', 'studyFirstSubmitDate': '2021-09-21', 'studyFirstSubmitQcDate': '2021-10-12', 'lastUpdatePostDateStruct': {'date': '2021-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intermediate Care (IMC) indication (VASi)', 'timeFrame': '2019/2020', 'description': 'Health care raters graded the IMC indication (or allocative efficiency) for each patient on a visual analog scale grading from 0 (very low indication of an IMC management) to 100 (very high indication of an IMC management), namely VASi.'}, {'measure': 'Intermediate Care benefit (VASb)', 'timeFrame': '2019/2020', 'description': 'Health care raters graded the IMC benefit (or health gain) for each patient on a visual analog scale grading from 0 (very low benefit from an IMC management) to 100 (very high benefit from an IMC management), namely VASb.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Post-Anesthesia Care Unit', 'Intermediate Care Unit', 'Clinical pathways', 'Decision making'], 'conditions': ['Perioperative Complication']}, 'referencesModule': {'references': [{'pmid': '40756574', 'type': 'DERIVED', 'citation': 'Perret L, Buclin CP, Courvoisier DS, Walder B. Reliability and validity of a new postoperative track assessment tool (PoTra-tool) as a decision-making aid: A prospective observational study. Eur J Anaesthesiol Intensive Care. 2025 May 29;4(4):e0076. doi: 10.1097/EA9.0000000000000076. eCollection 2025 Aug.'}]}, 'descriptionModule': {'briefSummary': 'This prospective observational study investigated the validity and reliability of a new postoperative track assessment tool. We hypothesized, first, that this tool estimates the indication and benefit of a management in an intermediate care unit (IMC). Second, we hypothesized that a) health care providers of IMC or postoperative anaesthesia care unit (PACU) have similar estimations using this tool and b) that this estimation is accurately established in the first 2 hours.', 'detailedDescription': 'The tool includes 2 visual analog scale (VAS) scores estimating indication of an IMC admission and benefit of an IMC stay. The tool was tested in a PACU and in an IMC unit of a Swiss tertiary centre in 2019/2020 (before COVID pandemic). Three raters: one nurse, one physician in charge and the consultant physician, were asked to fill the VAS at the same time for each included patient. The score was done in the 2 first hours following admission in the unit and during the multi professional morning round at day 1.\n\nReliability was estimated by testing internal consistency (homogeneity), interrater reliability and agreement and test-retest validity (stability). Validity included content validity, construct validity and criterion validity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "This study was a random sample from the PACU and IMC patients' population. Included patients' variables for demographic description of the population of interest and for the validity testing were: Age in years, gender (male / female), ASA physical score classification (ASA PS), do not resuscitate order (DNR), duration of intervention (min), severity of intervention (minor/intermediate/major), type of surgery (abdominal, orthopedic, trauma and other surgical and non-surgical interventions), elective or non-elective, palliative intervention, SAPS II (admission (2 h after arrival in IMC)), NEMS (admission (2 h after arrival) and during stay in IMC), SAS.\n\nParticipating raters were voluntary health care providers working in the peri-interventional unit (PACU and IMC).", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* PACU patients admitted on Mondays\n* IMC patients admitted 7:30am-7:30pm on weekdays\n\nExclusion Criteria:\n\n* night admission\n* PACU patient ASA \\< 3 or minor intervention'}, 'identificationModule': {'nctId': 'NCT05092867', 'acronym': 'POTraTool', 'briefTitle': 'Reliability and Validity of a New Postoperative Track Assessment Tool', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Geneva'}, 'officialTitle': 'Reliability and Validity of a New Postoperative Track Assessment Tool - a Prospective Observational Study', 'orgStudyIdInfo': {'id': '14032019'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Po Tra tool', 'type': 'OTHER', 'description': 'Healthcare workers filled the 2 VAS of the tool but it did not impact or change the care of the patient. (observational)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1205', 'city': 'Geneva', 'country': 'Switzerland', 'facility': 'Geneva University Hospital', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}], 'overallOfficials': [{'name': 'Walder, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital, Geneva'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Geneva', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Laurelie Perret', 'investigatorAffiliation': 'University Hospital, Geneva'}}}}