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The Hypotension Prediction Index in Free Flap Transplant in Head and Neck Surgery.

Primary Purpose

Hypotension, Head and Neck Cancer, Perioperative Complication

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hypotension Prediction Index
Sponsored by
Jakub Szrama
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypotension focused on measuring Hypotension, Hypotension Prediction Index, Free Flap Transplant, Head and Neck Cancer, Perioperative Complications

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients qualified to head and neck free flap surgery Written informed consent Exclusion Criteria: Patients under 18 years Lack of health insurance Pregnancy Known history of congenital heart disease, severe aortic and/or mitral stenosis, heart failure and ejection fraction < 35 % Persistent atrial fibrillation and other arrhythmias impairing arterial pressure-based cardiac output (APCO) monitoring

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Standard Therapy Group

    Hypotension Prediction Index Group

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    TWA Mean Arterial Pressure (MAP) < 65 mmHg
    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

    Secondary Outcome Measures

    TWA - MAP < 60 mmHg
    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
    TWA - MAP < 55 mmHg
    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
    30 day mortality
    30 day mortality
    Length of hospitalisation
    Length of hospitalisation

    Full Information

    First Posted
    January 15, 2023
    Last Updated
    February 12, 2023
    Sponsor
    Jakub Szrama
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05738603
    Brief Title
    The Hypotension Prediction Index in Free Flap Transplant in Head and Neck Surgery.
    Official Title
    The Hypotension Prediction Index in Free Flap Transplant in Head and Neck Surgery - a Pilot Study.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 2023 (Anticipated)
    Primary Completion Date
    December 2023 (Anticipated)
    Study Completion Date
    December 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Jakub Szrama

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypotension, Head and Neck Cancer, Perioperative Complication, Postoperative Complications
    Keywords
    Hypotension, Hypotension Prediction Index, Free Flap Transplant, Head and Neck Cancer, Perioperative Complications

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    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).
    Masking
    Participant
    Masking Description
    The studied patients will be blinded to the enrolled group.
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Standard Therapy Group
    Arm Type
    No Intervention
    Arm 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.
    Arm Title
    Hypotension Prediction Index Group
    Arm Type
    Experimental
    Arm 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.
    Intervention Type
    Device
    Intervention Name(s)
    Hypotension Prediction Index
    Intervention Description
    Hemodynamic perioperative monitoring with the Hypotension Prediction Index
    Primary Outcome Measure Information:
    Title
    TWA Mean Arterial Pressure (MAP) < 65 mmHg
    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
    Time Frame
    From the beginning of the anesthesia to the end of anesthesia
    Secondary Outcome Measure Information:
    Title
    TWA - MAP < 60 mmHg
    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
    Time Frame
    From the beginning of the anesthesia to the end of anesthesia
    Title
    TWA - MAP < 55 mmHg
    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
    Time Frame
    From the beginning of the anesthesia to the end of anesthesia
    Title
    30 day mortality
    Description
    30 day mortality
    Time Frame
    30 days
    Title
    Length of hospitalisation
    Description
    Length of hospitalisation
    Time Frame
    From date of randomisation to the date of hospital discharge or date of death, whichever came first, assesed up to 3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients qualified to head and neck free flap surgery Written informed consent Exclusion Criteria: Patients under 18 years Lack of health insurance Pregnancy Known history of congenital heart disease, severe aortic and/or mitral stenosis, heart failure and ejection fraction < 35 % Persistent atrial fibrillation and other arrhythmias impairing arterial pressure-based cardiac output (APCO) monitoring
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jakub Szrama, Ph.D.
    Phone
    +48 618691856
    Ext
    +48
    Email
    jakub.szrama@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jakub Szrama, Ph.D.
    Organizational Affiliation
    Poznan Univeristy of Medical Sciences, Department of Anesthesiology, Intensive Therapy
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    17667564
    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.
    Results Reference
    background
    PubMed Identifier
    29429638
    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.
    Results Reference
    background
    PubMed Identifier
    32065827
    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.
    Results Reference
    background
    PubMed Identifier
    32960954
    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.
    Results Reference
    background
    PubMed Identifier
    34322869
    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.
    Results Reference
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    The Hypotension Prediction Index in Free Flap Transplant in Head and Neck Surgery.

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