Ignite Creation Date:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2025-12-26 @ 11:49 AM
Study NCT ID:
NCT04822116
Status:
COMPLETED
Last Update Posted:
2021-03-30
First Post:
2019-06-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Continuation of Goal Directed Haemodynamic Optimization in the PACU
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}], 'ancestors': [{'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'In the study group volume therapy is based on variables like stroke volume and/or diameter of vena cava inferior based on a goal directed haemodynamic optimization protocol.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-25', 'studyFirstSubmitDate': '2019-06-21', 'studyFirstSubmitQcDate': '2021-03-25', 'lastUpdatePostDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'acute kidney failure', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Number of post-operative complications'}, {'measure': 'pulmonary oedema', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Number of post-operative complications'}, {'measure': 'wound infection', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Number of post-operative complications'}, {'measure': 'pneumonia', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Number of post-operative complications'}], 'secondaryOutcomes': [{'measure': 'length of stay in the PACU', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'through study completion'}, {'measure': 'length of stay in hospital', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'through study completion'}, {'measure': '28-day survival', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'through study completion'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Goal directed haemodynamic optimization', 'Ultrasound Imaging', 'Postoperative complications'], 'conditions': ['Hemodynamic Instability', 'Postoperative Complications', 'Ultrasound Imaging']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': "Aldrete JA, Kroulik D A postanesthetic recovery score. Anesth Analg 1970; 49: 924-34. McLaren JM, Reynolds JA, Cox MM, et al. Decreasing the length of stay in phase I postanesthesia care unit: an evidence-based approach. J Perianesth Nurs 2015; 30: 116-23. Ameloot K, Van De Vijver K, Van Regenmortel N, et al. Validation study of Nexfin(R) continuous non-invasive blood pressure monitoring in critically ill adult patients. Minerva Anestesiol 2014; 80: 1294-301. Batz G, Dinkel M [Hemodynamic monitoring - imaging procedures / cardiac ultrasound]. Anasthesiol Intensivmed Notfallmed Schmerzther 2016; 51: 626-34. White PF, Song D New criteria for fast-tracking after outpatient anesthesia: a comparison with the modified Aldrete's scoring system. Anesth Analg 1999; 88: 1069-72. Broch O, Carstens A, Gruenewald M, et al. Non-invasive hemodynamic optimization in major abdominal surgery: a feasibility study. Minerva Anestesiol 2016; 82: 1158-69."}]}, 'descriptionModule': {'briefSummary': 'Post-operative monitoring of all patients after anaesthesia in the post anaesthesia care unit (PACU) is standard of care today. It helps to reduce morbidity and even mortality in high-risk patients.\n\nIn addition to clinical monitoring by qualified staff, standard monitoring in the PACU includes non-invasive, intermittent, haemodynamic monitoring.\n\nThis research is going to investigate the influence of the continuation of goal directed haemodynamic optimization in the recovery room on the basis of non-invasive monitoring tools, i.e. ultrasound and the volume-clamp method, in regard of length of stay in the PACU and postoperative complications.', 'detailedDescription': 'Postoperative monitoring of all patients after surgery in post anaesthesia care unit (PACU) is standard of care today. It helps to reduce morbidity and even mortality in high-risk patients.\n\nIn addition to clinical monitoring by qualified staff, standard monitoring in the PACU includes non-invasive, intermittent, haemodynamic monitoring. The time of transfer of patients from the PACU to the general ward is assessed on the basis of several parameters. There is consensus on the most important endpoints of transferability: awareness, quality of spontaneous breathing, circulatory situation, bleeding situation, body temperature, diuresis and satisfactory freedom from pain and absence of nausea, but the processes and contents and how they can be established as quickly and sustainable as possible are not yet defined.\n\nThis research will investigate the influence of continuing non-invasive, goal-directed haemodynamic optimization in the recovery room, after major traumatological, general and vascular surgery.\n\nIn a randomized controlled trial the investigators will include a population of 80 patients with a minimum age of 18 years in the study after clarification and approval.\n\nThe control group will be routinely treated with an appropriate protocol for goal-oriented haemodynamic optimization. The study group will receive targeted haemodynamic optimization using Vigileo FlowTrac-Analysis and transthoracic echocardiography in the operation room and finger-cuff based pulse analysis technology in the PACU. The observed parameters of targeted haemodynamic optimization will be stroke volume and cardiac output, volume response parameters and collapsability of the inferior vena cava for the volume status.\n\nAs primary endpoints the investigators considered the number of postoperative complications. As secondary endpoints, the investigators will compare the time spent in the recovery room, the time spent in hospital and 28-day mortality and morbidity.\n\nThe hypothesis is that, in patients classified ASA II and III, a continuation of a targeted haemodynamic optimization in the PACU with non-invasive monitoring methods can reduce postoperative complications after a variety of surgical procedures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with ASA classification I-III undergoing abdominal surgery, surgery in urology or vascular surgery\n* written consent\n\nExclusion Criteria:\n\n* Age \\<18 years\n* ASA classification IV or higher\n* legal care relationship\n* missing or faulty written consent'}, 'identificationModule': {'nctId': 'NCT04822116', 'briefTitle': 'Continuation of Goal Directed Haemodynamic Optimization in the PACU', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Schleswig-Holstein'}, 'officialTitle': 'Continuation of Goal Directed Haemodynamic Optimization in the Postanaesthesia Care Unit on the Basis of Non-invasive Methods: a Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': 'IN-PACU-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'standard of care', 'description': 'Standard of care defined as "standard operating procedure", including a goal directed intraoperative haemodynamic optimization protocol.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'goal directed intraoperative haemodynamic optimization', 'description': 'Standard of care defined as "standard operating procedure", including a goal directed intraoperative haemodynamic optimization protocol. Additional application of a non-invasive haemodynamic optimization protocol in the post anaesthesia care unit.', 'interventionNames': ['Other: goal directed intraoperative haemodynamic optimization']}], 'interventions': [{'name': 'goal directed intraoperative haemodynamic optimization', 'type': 'OTHER', 'otherNames': ['crystalloids', 'transthoracic echocardiography', 'volume clamp method'], 'description': 'all interventions that were pre-specified to be administered as part of the protocol', 'armGroupLabels': ['goal directed intraoperative haemodynamic optimization']}]}, 'contactsLocationsModule': {'locations': [{'zip': '24105', 'city': 'Kiel', 'state': 'Deutschland (deu)', 'country': 'Germany', 'facility': 'Universitätsklinikum Schleswig-Holstein Campus Kiel - Klinik für Anästhesiologie und Operative Intensivmedizin', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}], 'overallOfficials': [{'name': 'Jochen Renner, prof. Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital Schleswig-Holstein, Kiel'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Schleswig-Holstein', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Dr. Jochen Renner', 'investigatorAffiliation': 'University Hospital Schleswig-Holstein'}}}}