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PPI Guided Strategies for Prevention and Treatment of Intraoperative Hypotension

Primary Purpose

Intraoperative Hypotension

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PPI guided strategies
Empirical strategies
Sponsored by
zhiqiang zhou
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Intraoperative Hypotension focused on measuring Intraoperative hypotension, Peripheral perfusion indexI, General anesthesia, Non-cardiac surgery

Eligibility Criteria

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

Inclusion Criteria: 65 years and older ASA Physical Status 1-3 general anesthesia arterial catheterization procedures last more than 2 hours communicate normally in Mandarin Exclusion Criteria: abnormal Allen's test higher target than 65 mmHg history of diabetes vascular diseases arrhythmia cardiac function class II and above physical disability, unable to conduct PPI monitoring participated in other clinical studies in the past month

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    PPI guided strategies

    conventional strategies

    Arm Description

    The decision making for prevention and treatment of hypotension was PPI guided to maintain the PPI between 1 and 3.

    The decision making for prevention and treatment of hypotension dependent on the experience of anesthesiologist.

    Outcomes

    Primary Outcome Measures

    time-weighted average of hypotension (TWA)<65mmHg
    total area under MAP<65 mmHg/surgery length

    Secondary Outcome Measures

    Rate of hypotension after anesthesia induction
    the number of participants of hypotension/ the number of each group
    Cumulative number of intraoperative hypotension episodes
    Cumulative number of MAP<65mmHg and last at least for three minutes
    Cumulative time of intraoperative hypotension period
    Cumulative time of MAP<65mmHg
    Proportion of time with hypotension
    Proportion of cumulative time of intraoperative hypotension period and the anesthesia time
    time-weighted average of hypertension (TWA)>100mmHg
    total area under MAP>100 mmHg/surgery length
    Cumulative number of intraoperative hypertension episodes
    Cumulative number of MAP>100 mmHg and last at least for three minutes
    postoperative plasma concentration of lactic acid
    Plasma concentration of lactic acid in the end of surgery
    arterial partial pressure of oxygen (PaO2)/inspired fraction of oxygen (FiO2)
    PaO2/FiO2
    intraoperative urine output
    urine output during the surgery
    the rate of acute kidney injury (AKI)
    the number of participants with AKI/ the number of each group

    Full Information

    First Posted
    March 19, 2023
    Last Updated
    April 11, 2023
    Sponsor
    zhiqiang zhou
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05792696
    Brief Title
    PPI Guided Strategies for Prevention and Treatment of Intraoperative Hypotension
    Official Title
    Effectiveness of Peripheral Perfusion Index Guided Strategies for the Prevention and Treatment of Hypotension: a Randomized Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 1, 2023 (Anticipated)
    Primary Completion Date
    October 31, 2023 (Anticipated)
    Study Completion Date
    October 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    zhiqiang zhou

    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
    Intraoperative hypotension is closely related to the poor prognosis of surgery. The study is focused on the effectiveness of maintaining normal peripheral perfusion index (PPI) on time-weighted average of hypotension during anesthesia.
    Detailed Description
    Intraoperative hypotension is closely related to the poor prognosis of surgery. Hypotension decreased blood flow perfusion of organs, which lead to dysfunction of multiple organs, especially increasing serious complications such as cardio-cerebrovascular events and acute renal injury within 30 days after surgery. The aim of this study is to establish a set of strategies that can effectively prevent and treat intraoperative hypotension, so as to alleviate possible harm to patients from perioperative hypotension. The study is focused on the effectiveness of maintaining normal peripheral perfusion index (PPI) on time-weighted average of hypotension during anesthesia. The lower target mean arterial pressure (MAP) was higher than 65 mmHg. MAP less than 65 mmHg was defined as intraoperative hypotension between induction and tracheal extubation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Intraoperative Hypotension
    Keywords
    Intraoperative hypotension, Peripheral perfusion indexI, General anesthesia, Non-cardiac surgery

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    54 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    PPI guided strategies
    Arm Type
    Experimental
    Arm Description
    The decision making for prevention and treatment of hypotension was PPI guided to maintain the PPI between 1 and 3.
    Arm Title
    conventional strategies
    Arm Type
    Other
    Arm Description
    The decision making for prevention and treatment of hypotension dependent on the experience of anesthesiologist.
    Intervention Type
    Behavioral
    Intervention Name(s)
    PPI guided strategies
    Intervention Description
    For targeted MAP or lower, if PPI<1, more fluid therapy. if PPI>3, vasoconstriction therapy. For MAP<65mmHg and 1<=PPI<3, test bolus of 250 ml crystalloid fluid.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Empirical strategies
    Intervention Description
    Fluid therapy or vasoconstriction depended on experiences of anesthetic staffs.
    Primary Outcome Measure Information:
    Title
    time-weighted average of hypotension (TWA)<65mmHg
    Description
    total area under MAP<65 mmHg/surgery length
    Time Frame
    Intraoperative (between anesthesia induction and tracheal extubation)
    Secondary Outcome Measure Information:
    Title
    Rate of hypotension after anesthesia induction
    Description
    the number of participants of hypotension/ the number of each group
    Time Frame
    from anesthesia induction to 15 minutes after then
    Title
    Cumulative number of intraoperative hypotension episodes
    Description
    Cumulative number of MAP<65mmHg and last at least for three minutes
    Time Frame
    Intraoperative (between anesthesia induction and tracheal extubation)
    Title
    Cumulative time of intraoperative hypotension period
    Description
    Cumulative time of MAP<65mmHg
    Time Frame
    Intraoperative (between anesthesia induction and tracheal extubation)
    Title
    Proportion of time with hypotension
    Description
    Proportion of cumulative time of intraoperative hypotension period and the anesthesia time
    Time Frame
    Intraoperative (between anesthesia induction and tracheal extubation)
    Title
    time-weighted average of hypertension (TWA)>100mmHg
    Description
    total area under MAP>100 mmHg/surgery length
    Time Frame
    Intraoperative (between anesthesia induction and tracheal extubation)
    Title
    Cumulative number of intraoperative hypertension episodes
    Description
    Cumulative number of MAP>100 mmHg and last at least for three minutes
    Time Frame
    Intraoperative (between anesthesia induction and tracheal extubation)
    Title
    postoperative plasma concentration of lactic acid
    Description
    Plasma concentration of lactic acid in the end of surgery
    Time Frame
    5 minutes before and 5 minutes after the end of surgery
    Title
    arterial partial pressure of oxygen (PaO2)/inspired fraction of oxygen (FiO2)
    Description
    PaO2/FiO2
    Time Frame
    5 minutes before and 5 minutes after the end of surgery
    Title
    intraoperative urine output
    Description
    urine output during the surgery
    Time Frame
    Intraoperative (between anesthesia induction and tracheal extubation)
    Title
    the rate of acute kidney injury (AKI)
    Description
    the number of participants with AKI/ the number of each group
    Time Frame
    within 7 days after the end of surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 65 years and older ASA Physical Status 1-3 general anesthesia arterial catheterization procedures last more than 2 hours communicate normally in Mandarin Exclusion Criteria: abnormal Allen's test higher target than 65 mmHg history of diabetes vascular diseases arrhythmia cardiac function class II and above physical disability, unable to conduct PPI monitoring participated in other clinical studies in the past month
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Zhiqiang Zhou, Dr.
    Phone
    862783663173
    Email
    zqzhou@tjh.tjmu.edu.cn
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Zhiqiang Zhou
    Organizational Affiliation
    Tongji Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    PPI Guided Strategies for Prevention and Treatment of Intraoperative Hypotension

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