Ignite Creation Date:
2025-12-25 @ 12:59 AM
Ignite Modification Date:
2026-01-03 @ 4:50 PM
Study NCT ID:
NCT04188093
Status:
COMPLETED
Last Update Posted:
2022-01-11
First Post:
2019-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Identifying Patients in Risk of Post-operative Complications Using PACU Discharge Criteria
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-20', 'studyFirstSubmitDate': '2019-11-26', 'studyFirstSubmitQcDate': '2019-12-04', 'lastUpdatePostDateStruct': {'date': '2022-01-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'description of other physiological deviations', 'timeFrame': 'during hospital stay, up to 30 days', 'description': 'description og frequency and duration of other physiological deviations (fever, arrythmia, apnea, arrythmia, etc)'}], 'primaryOutcomes': [{'measure': 'Clinical in-hospital complications', 'timeFrame': 'until discharge, up to 90 days', 'description': 'Occurence of clinical complications occuring during the hospital stay (pneumonia, myocardial infarction, brain stroke, renal impairment, etc), based upon international definitions'}], 'secondaryOutcomes': [{'measure': 'Bradycardia', 'timeFrame': 'During the first 4 postoperative days', 'description': 'pulse \\<40/min measured by pulse oximeter'}, {'measure': 'Tachycardia', 'timeFrame': 'During the first 4 postoperative days', 'description': 'pulse \\>140/min meausured by pulseoximetry'}, {'measure': 'Severe desaturation', 'timeFrame': 'During the first 4 postoperative days', 'description': 'Arterial saturation \\<85% lasting \\>10 minutes per episode, measured by pulse oximeter'}, {'measure': 'Very severe desaturation', 'timeFrame': 'During the first 4 postoperative days', 'description': 'Arterial saturation \\<80% lasting \\>10 minutes per episode, measured by pulse oximeter'}, {'measure': 'Hypotension', 'timeFrame': 'During the first 4 postoperative days', 'description': 'Middle arterial blood pressure \\<75 for \\>29 minutes measured by non-invasive manometer'}, {'measure': 'Severe hypotension', 'timeFrame': 'During the first 4 postoperative days', 'description': 'Middle arterial blood pressure \\<65 for \\>29 minutes measured by non-invasive manometer'}, {'measure': 'bradypnea', 'timeFrame': 'During the first 4 postoperative days', 'description': 'respiratory rate \\<8/min for 30 minutes, measured by ECG'}, {'measure': 'Tachypnea', 'timeFrame': 'During the first 4 postoperative days', 'description': 'respiratory rate \\>20/min for 30 minutes, measured by ECG'}, {'measure': 'Severe tachypnea', 'timeFrame': 'During the first 4 postoperative days', 'description': 'respiratory rate \\>30/min for 30 minutes, measured by ECG'}, {'measure': 'Clinical out of hospital complications', 'timeFrame': 'until 96 days postoperatively', 'description': 'Occurence of clinical complications occuring after the hospital stay (pneumonia, myocardial infarction, brain stroke, renal impairment, etc), based upon international definitions'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PACU', 'Postoperative Care Unit', 'Continous monitoring', 'PACU discharge criteria'], 'conditions': ['Complication,Postoperative', 'Post-Op Complication']}, 'descriptionModule': {'briefSummary': 'In the Postoperative Care Unit surgical patients are monitored closely to ensure safe condition before transfer to the ward. This study will aim to identify patients in risk of complications on the ward using the national postanesthesia care unit (PACU) discharge criteria, a modified Aldretes score. Secondary to identify patients in risk of micro events as detected by continuous monitoring of vital signs on the ward.', 'detailedDescription': 'Patients undergoing esophageal resection and pancreaticoduodenectomy are at high risk of developing complications after surgery. Described patient groups are monitored for at least 24 hours in PACU before returning to the ward.\n\nIn Denmark physiological parameters are assessed in the PACU every hour until discharge using the DASAIM discharge criteria (A modified Aldrete score).\n\nThe PACU discharge score is calculated on parameters including sedation, respiratory rate, saturation, systolic blood pressure, puls, physical capability (if epidural or spinal anesthesia), pain in rest, nausea, diuresis and temperature. Each parameter is given a score between 0 and 3. 0 describes no problem and 3 describes a severe problem.\n\nThe investigators will investigate the predictive value of the PACU discharge criteria and interventions in the PACU setting, to identify patients at risk of developing postoperative complications. Secondary outcome is micro events on the ward. Patients vital signs are monitored continuously from PACU discharge until the 5th postoperative day. Micro events are defined as deviations of vital parameters from normal range.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '110 Years', 'minimumAge': '60 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients over 60 years under surgery for abdominal cancer.\n\n* Pancreaticoduodenectomy (KJLC30)\n* transthoracic esophageal resection without interposition (KJCC10)\n\nPatients undergoing described surgery stay at least 24 hours in PACU following local guidelines', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elective surgery\n* Pancreaticoduodenectomy (KJLC30)\n* Transthoracic esophageal resection without interposition (KJCC10)\n\nExclusion Criteria:\n\n* Patients not expected to be able to cooperate\n* Patients not cognitive well (Mini Mental State Examination \\< 24)\n* Pacemaker\n* Patients with allergies including band aid, plastic and silicone'}, 'identificationModule': {'nctId': 'NCT04188093', 'briefTitle': 'Identifying Patients in Risk of Post-operative Complications Using PACU Discharge Criteria', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Identifying Patients in Risk of Post-operative Complications Using PACU Discharge Criteria and Need for Interventions in the PACU Setting', 'orgStudyIdInfo': {'id': 'PIRCPAC'}}, 'armsInterventionsModule': {'interventions': [{'name': 'PACU discharge criteria and continuous monitoring on the ward', 'type': 'OTHER', 'description': '* PACU discharge criteria (modified aldrete score).\n* Continous monitoring of vital signs 96 postoperative hours'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Eske K Aasvang, Dr. Med.', 'role': 'STUDY_CHAIR', 'affiliation': 'Rigshospitalet, Denmark'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of research, Clinical professor, Principal Investigator', 'investigatorFullName': 'Eske Kvanner Aasvang', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}