search
Back to results

Post Anaesthesia Care Hypotension Prevention (PACH-1)

Primary Purpose

Hypotension During Surgery

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
HPI (using HemoSphere) - guided algorithm
Treatment of hypotension following standard of care
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypotension During Surgery focused on measuring Laparotomy, Hypotension, Goal Directed Therapy, Post-operative, Prediction, Artificial intelligence

Eligibility Criteria

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

Inclusion Criteria: Patients > 18 years old Patients planned to undergo laparotomy surgery Patients that will receive an invasive arterial catheter as part of their procedure Patients that are planned to go to the post anaesthetic care unit (PACU) post-operatively Exclusion Criteria: Patients with known arrythmias Patients with known severe heart valve disease Patients with the need for dialysis Clamping of the aorta or Pringle's manoeuvre during surgery Emergency procedures

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    HPI-intervention algorithm

    Control group

    Arm Description

    In the intervention group the HemoSphere screen is visible and the anesthesiologist and PACU personal are instructed to follow the algorithm (chapter 4) in case of a HPI >85%. The purpose of the alarm at 85% and the presented algorithm is to prevent hypotension. If hypotension occurs, it should be treated as according to the standard of care.

    Patients in the control group are connected to the HemoSphere monitor to evaluate the TWA of hypotension in this group. The screen is not visible to the anesthesiologist or PACU personal and the alarm is set silent. It will be explained to the anesthesiologist and PACU personal that the patients are included to this study and that a blood pressure with a MAP of 65 mmHg should be monitored.

    Outcomes

    Primary Outcome Measures

    Time Weighted Average of hypotension
    Time Weighted Average (TWA) is measured as (depth of hypotension in mmHg below a MAP op 65mmHg x time in minutes spent below a MAP of 65mmHg) ÷ total duration of surgery/PACU admission in minutes)

    Secondary Outcome Measures

    Frequency and duration of hypotension
    Defined as MAP<65mmHg for at least 1 minute
    Frequency and duration of hypertension
    Defined as MAP>100mmHg for at least 1 minute
    Total amount of administered fluids
    Total amount of administered fluids (absolute, ml/kg/min, input/output ratio)
    Total administration of vasopressors
    Total administration of vasopressors (mcg/kg/min)
    Total administration of inotropy
    Total administration of inotropy (mcg/kg/min)
    Eligibility for discharge to the ward on the day after surgery
    Eligibility defined as yes or no
    Lactate
    Lactate level as measured in arterial blood gas
    Glomerular filtration rate
    Glomerular filtration rate as measured in arterial blood gas
    Number and type of complications in the first 30 days after surgery
    Number and type of complications in the first 30 days after surgery

    Full Information

    First Posted
    March 30, 2023
    Last Updated
    April 25, 2023
    Sponsor
    Radboud University Medical Center
    Collaborators
    Edwards Lifesciences
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05844774
    Brief Title
    Post Anaesthesia Care Hypotension Prevention
    Acronym
    PACH-1
    Official Title
    The Clinical Effects of Perioperative Use of the Hypotension Prediction Index
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 22, 2023 (Anticipated)
    Primary Completion Date
    June 1, 2024 (Anticipated)
    Study Completion Date
    August 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Radboud University Medical Center
    Collaborators
    Edwards Lifesciences

    4. Oversight

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

    5. Study Description

    Brief Summary
    The goal of this clinical trial is to investigate if the use of the hypotension prediction index during the perioperative period leads to a decrease in hypotension both during and after surgery (24 hrs) in adults undergoing major abdominal surgery. The main question this trial aims to answer is: • Does the use of the hypertension prediction index (HPI) decrease hypotension during surgery and in the post-operative period? During and after their surgery, participants in the intervention group will be treated according to the HPI-algorithm. Participants in the control group will be treated following the standard of care.
    Detailed Description
    Rationale: Hypotension during and after surgery is associated with serious complications. Using a machine learning algorithm, hypotension can be accurately predicted. Edwards Lifesciences developed this algorithm, called "Hypotension Prediction Index" and integrated this in their hemodynamical monitors. Recent studies have shown a decrease in intraoperative hypotension when using the hypotension prediction index. Objective: To investigate if the use of the hypotension prediction index during the perioperative period leads to a decrease in hypotension (time weighted average) both during and after surgery (24 hrs). Intervention: Patients in the intervention group will be treated using the hypotension prediction index algorithm to prevent hypotension. In case of actual hypotension the treatment thereof is at the discretion of the anaesthesiologist. Main study parameters/endpoints: The decrease in time weighted average of hypotension in the peri- and post-operative period.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypotension During Surgery
    Keywords
    Laparotomy, Hypotension, Goal Directed Therapy, Post-operative, Prediction, Artificial intelligence

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    1 control group, 1 intervention group without cross-over
    Masking
    None (Open Label)
    Masking Description
    Open label clinical trial
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    HPI-intervention algorithm
    Arm Type
    Experimental
    Arm Description
    In the intervention group the HemoSphere screen is visible and the anesthesiologist and PACU personal are instructed to follow the algorithm (chapter 4) in case of a HPI >85%. The purpose of the alarm at 85% and the presented algorithm is to prevent hypotension. If hypotension occurs, it should be treated as according to the standard of care.
    Arm Title
    Control group
    Arm Type
    Other
    Arm Description
    Patients in the control group are connected to the HemoSphere monitor to evaluate the TWA of hypotension in this group. The screen is not visible to the anesthesiologist or PACU personal and the alarm is set silent. It will be explained to the anesthesiologist and PACU personal that the patients are included to this study and that a blood pressure with a MAP of 65 mmHg should be monitored.
    Intervention Type
    Device
    Intervention Name(s)
    HPI (using HemoSphere) - guided algorithm
    Intervention Description
    Treatment of hypotension guided by the hypotension prediction index. Patients will receive treatment following the predetermined HPI-algorithm when the HPI exceeds 85%.
    Intervention Type
    Device
    Intervention Name(s)
    Treatment of hypotension following standard of care
    Intervention Description
    Patients receive standard of care treatment for hypotension, with a goal-mean arterial pressure (MAP) of 65mmHg.
    Primary Outcome Measure Information:
    Title
    Time Weighted Average of hypotension
    Description
    Time Weighted Average (TWA) is measured as (depth of hypotension in mmHg below a MAP op 65mmHg x time in minutes spent below a MAP of 65mmHg) ÷ total duration of surgery/PACU admission in minutes)
    Time Frame
    During the accumulative duration of surgery and PACU admission
    Secondary Outcome Measure Information:
    Title
    Frequency and duration of hypotension
    Description
    Defined as MAP<65mmHg for at least 1 minute
    Time Frame
    During surgery and in the 24 hours following surgery
    Title
    Frequency and duration of hypertension
    Description
    Defined as MAP>100mmHg for at least 1 minute
    Time Frame
    During surgery and in the 24 hours following surgery
    Title
    Total amount of administered fluids
    Description
    Total amount of administered fluids (absolute, ml/kg/min, input/output ratio)
    Time Frame
    During surgery and in the 24 hours following surgery
    Title
    Total administration of vasopressors
    Description
    Total administration of vasopressors (mcg/kg/min)
    Time Frame
    During surgery and in the 24 hours following surgery
    Title
    Total administration of inotropy
    Description
    Total administration of inotropy (mcg/kg/min)
    Time Frame
    During surgery and in the 24 hours following surgery
    Title
    Eligibility for discharge to the ward on the day after surgery
    Description
    Eligibility defined as yes or no
    Time Frame
    During morning rounds the day after surgery (approximately at 10.00hours)
    Title
    Lactate
    Description
    Lactate level as measured in arterial blood gas
    Time Frame
    "at the start of surgery", "at PACU admission", "day after surgery at 06.00hours"
    Title
    Glomerular filtration rate
    Description
    Glomerular filtration rate as measured in arterial blood gas
    Time Frame
    "at the start of surgery", "at PACU admission", "day after surgery at 06.00hours"
    Title
    Number and type of complications in the first 30 days after surgery
    Description
    Number and type of complications in the first 30 days after surgery
    Time Frame
    30 days after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients > 18 years old Patients planned to undergo laparotomy surgery Patients that will receive an invasive arterial catheter as part of their procedure Patients that are planned to go to the post anaesthetic care unit (PACU) post-operatively Exclusion Criteria: Patients with known arrythmias Patients with known severe heart valve disease Patients with the need for dialysis Clamping of the aorta or Pringle's manoeuvre during surgery Emergency procedures
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Van Eijk
    Phone
    0624501517
    Email
    lucas.vaneijk@radboudumc.nl
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sieffers
    Phone
    0646306609
    Email
    matthijs.sieffers@radboudumc.nl
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Van Eijk
    Organizational Affiliation
    Coordinating Investigator
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Post Anaesthesia Care Hypotension Prevention

    We'll reach out to this number within 24 hrs