Ignite Creation Date:
2025-12-24 @ 7:22 PM
Ignite Modification Date:
2025-12-25 @ 5:02 PM
Study NCT ID:
NCT05738603
Status:
RECRUITING
Last Update Posted:
2025-08-03
First Post:
2023-01-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Hypotension Prediction Index in Free Flap Transplant in Head and Neck Surgery.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007022', 'term': 'Hypotension'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'The studied patients will be blinded to the enrolled group.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This prospective, randomized, controlled clinical trial will be performed in Poznan University of Medical Science Hospital. Patients fulfilling the inclusion criteria (see below) will be randomly assigned to receive invasive blood pressure monitoring + standard medical therapy (group A) or the hemodynamic monitoring with the Hypotension Prediction Index software (group B).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 206}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-30', 'studyFirstSubmitDate': '2023-01-15', 'studyFirstSubmitQcDate': '2023-02-12', 'lastUpdatePostDateStruct': {'date': '2025-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'TWA Mean Arterial Pressure (MAP) < 65 mmHg', 'timeFrame': 'From the beginning of the anesthesia to the end of anesthesia', 'description': 'TWA - MAP \\< 65 mmHg - time weighed average = (depth of hypotension in millimeters of mercury below a MAP of 65 mmHg x time in minutes spent below MAP of 65mmHg)/total duration of operation in minutes'}], 'secondaryOutcomes': [{'measure': 'TWA - MAP < 60 mmHg', 'timeFrame': 'From the beginning of the anesthesia to the end of anesthesia', 'description': 'time weighed average = (depth of hypotension in millimeters of mercury below a MAP of 60 mmHg x time in minutes spent below MAP of 60 mmHg)/total duration of operation in minutes'}, {'measure': 'TWA - MAP < 55 mmHg', 'timeFrame': 'From the beginning of the anesthesia to the end of anesthesia', 'description': 'time weighed average = (depth of hypotension in millimeters of mercury below a MAP of 55 mmHg x time in minutes spent below MAP of 55 mmHg)/total duration of operation in minutes'}, {'measure': '30 day mortality', 'timeFrame': '30 days', 'description': '30 day mortality'}, {'measure': 'Length of hospitalisation', 'timeFrame': 'From date of randomisation to the date of hospital discharge or date of death, whichever came first, assesed up to 3 months', 'description': 'Length of hospitalisation'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hypotension', 'Hypotension Prediction Index', 'Free Flap Transplant', 'Head and Neck Cancer', 'Perioperative Complications'], 'conditions': ['Hypotension', 'Head and Neck Cancer', 'Perioperative Complication', 'Postoperative Complications']}, 'referencesModule': {'references': [{'pmid': '17667564', 'type': 'BACKGROUND', 'citation': 'Bijker JB, van Klei WA, Kappen TH, van Wolfswinkel L, Moons KG, Kalkman CJ. Incidence of intraoperative hypotension as a function of the chosen definition: literature definitions applied to a retrospective cohort using automated data collection. Anesthesiology. 2007 Aug;107(2):213-20. doi: 10.1097/01.anes.0000270724.40897.8e.'}, {'pmid': '29429638', 'type': 'BACKGROUND', 'citation': 'Gu WJ, Hou BL, Kwong JSW, Tian X, Qian Y, Cui Y, Hao J, Li JC, Ma ZL, Gu XP. Association between intraoperative hypotension and 30-day mortality, major adverse cardiac events, and acute kidney injury after non-cardiac surgery: A meta-analysis of cohort studies. Int J Cardiol. 2018 May 1;258:68-73. doi: 10.1016/j.ijcard.2018.01.137. Epub 2018 Feb 2.'}, {'pmid': '32065827', 'type': 'BACKGROUND', 'citation': 'Wijnberge M, Geerts BF, Hol L, Lemmers N, Mulder MP, Berge P, Schenk J, Terwindt LE, Hollmann MW, Vlaar AP, Veelo DP. Effect of a Machine Learning-Derived Early Warning System for Intraoperative Hypotension vs Standard Care on Depth and Duration of Intraoperative Hypotension During Elective Noncardiac Surgery: The HYPE Randomized Clinical Trial. JAMA. 2020 Mar 17;323(11):1052-1060. doi: 10.1001/jama.2020.0592.'}, {'pmid': '32960954', 'type': 'BACKGROUND', 'citation': 'Maheshwari K, Shimada T, Yang D, Khanna S, Cywinski JB, Irefin SA, Ayad S, Turan A, Ruetzler K, Qiu Y, Saha P, Mascha EJ, Sessler DI. Hypotension Prediction Index for Prevention of Hypotension during Moderate- to High-risk Noncardiac Surgery. Anesthesiology. 2020 Dec 1;133(6):1214-1222. doi: 10.1097/ALN.0000000000003557.'}, {'pmid': '34322869', 'type': 'BACKGROUND', 'citation': 'Grundmann CD, Wischermann JM, Fassbender P, Bischoff P, Frey UH. Hemodynamic monitoring with Hypotension Prediction Index versus arterial waveform analysis alone and incidence of perioperative hypotension. Acta Anaesthesiol Scand. 2021 Nov;65(10):1404-1412. doi: 10.1111/aas.13964. Epub 2021 Aug 31.'}, {'pmid': '40141745', 'type': 'DERIVED', 'citation': 'Szrama J, Gradys A, Wozniak A, Nowak Z, Bartkowiak T, Lohani A, Zwolinski K, Koszel T, Kusza K. The Hypotension Prediction Index in Free Flap Transplant in Head and Neck Surgery: Protocol of a Prospective Randomized Controlled Trial. Life (Basel). 2025 Mar 4;15(3):400. doi: 10.3390/life15030400.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the current study is to evaluate the effects of the Hypotension Prediction Index (HPI) on the degree of intraoperative hypotension in patients undergoing free flap surgery. The hypothesis is that implementation of the HPI algorithm will reduce the time-weighted average (TWA) intraoperative hypotension below a threshold of 65 mmHg (16), and to reveal the relationship between the episodes of hypotension and free flap viability and function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients qualified to head and neck free flap surgery\n* Written informed consent\n\nExclusion Criteria:\n\n* Patients under 18 years\n* Lack of health insurance\n* Pregnancy\n* Known history of congenital heart disease, severe aortic and/or mitral stenosis, heart failure and ejection fraction \\< 35 %\n* Persistent atrial fibrillation and other arrhythmias impairing arterial pressure-based cardiac output (APCO) monitoring'}, 'identificationModule': {'nctId': 'NCT05738603', 'briefTitle': 'The Hypotension Prediction Index in Free Flap Transplant in Head and Neck Surgery.', 'organization': {'class': 'OTHER', 'fullName': 'Poznan University of Medical Sciences'}, 'officialTitle': 'The Hypotension Prediction Index in Free Flap Transplant in Head and Neck Surgery - a Prospective Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': '560/22'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard Therapy Group', 'description': 'The standard therapy group patients will have invasive blood pressure monitoring + standard medical therapy. The therapeutic decision regarding treatment of hypotension, the use of fluids and vasopressors will be determined by the anaesthesia team. The decisions will be based on the information from the standard invasive blood pressure monitoring.'}, {'type': 'EXPERIMENTAL', 'label': 'Hypotension Prediction Index Group', 'description': 'The HPI-group will have the HPI based monitoring with the Acumen IQ sensor (Edwards Lifesciences) and the HPI algorithm connected also to the HemoSphere platform (Edwards Lifesciences). The hemodynamic management will be based on the HPI indications and the specific algorithm, which considers hypovolemia, impaired contractility and vasodilatation. An alert pops up on the monitor screen when the HPI values exceeds 85 and then the clinician needs to make therapeutic decision in order to avoid the hypotensive episode.', 'interventionNames': ['Device: Hypotension Prediction Index']}], 'interventions': [{'name': 'Hypotension Prediction Index', 'type': 'DEVICE', 'description': 'Hemodynamic perioperative monitoring with the Hypotension Prediction Index', 'armGroupLabels': ['Hypotension Prediction Index Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61-355', 'city': 'Poznan', 'state': 'Poznań', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Jakub Szrama, PhD', 'role': 'CONTACT', 'email': 'jakub.szrama@gmail.com', 'phone': '+48618691856'}, {'name': 'Agata Gradys, PhD', 'role': 'CONTACT', 'email': 'agatagradys@gmail.com', 'phone': '+48618691856'}], 'facility': 'Department of Anesthesiology, Intensive Therapy and Pain Management', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}], 'centralContacts': [{'name': 'Jakub Szrama, Ph.D.', 'role': 'CONTACT', 'email': 'jakub.szrama@gmail.com', 'phone': '+48 618691856', 'phoneExt': '+48'}], 'overallOfficials': [{'name': 'Jakub Szrama, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Poznan Univeristy of Medical Sciences, Department of Anesthesiology, Intensive Therapy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jakub Szrama', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jakub Szrama', 'investigatorAffiliation': 'Poznan University of Medical Sciences'}}}}