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Comparisons of Blood Pressure Control Ability Between HPI, ClearSight, and Conventional NIBP During Neuraxial Anesthesia in Cesarean Section

Primary Purpose

Intraoperative Hypotension, Cesarean Section

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
hypotension prediction index derived from non-invasive arterial pressure waveforms
non-invasive arterial pressure waveforms
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intraoperative Hypotension

Eligibility Criteria

20 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: 20 - 50 year-old parturients scheduled cesarean delivery neuraxial anesthesia Exclusion Criteria: parturients with preeclampsia parturients with cardiovascular disease above NYHA functional class 2 parturients with arrhythmias, preoperative severe hypertension, or other severe cardiopulmonary diseases. severe perioperative arrhythmias with or without hemodynamic instability failed neuraxial anesthesia or regional blockade level below T6

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    No Intervention

    Arm Label

    HPI

    ClearSight

    NIBP

    Arm Description

    Standard intraoperative monitor and non-invasive continuous arterial pressure waveforms (ClearSight) are set up in this group. ClearSight data and hypotension prediction index (HPI) derived from ClearSight are used for recording and monitoring. Blood pressure is monitored with ClearSight and HPI. Attending anesthesiologists controlled the blood pressure according to HPI values. Maintain HPI below 85 HPI > 85 and heart rate > 60/min, IV bolus norepinephrine 5-10 mcg HPI > 85 and heart rate < 60/min, IV bolus norepinephrine 5-10 mcg with atropine 0.01 mg/kg

    Standard intraoperative monitor and non-invasive continuous arterial pressure waveforms (ClearSight) are set up in this group. ClearSight data and HPI derived from ClearSight are used for recording, and HPI are masked for attending anesthesiologists. Blood pressure is monitored with ClearSight. Attending anesthesiologists controlled the blood pressure according to continuous arterial pressure values. Maintain mean arterial pressure (MAP) above 65 mmHg MAP < 65mmHg and heart rate > 60/min, IV bolus norepinephrine 5-10 mcg MAP < 65mmHg and heart rate < 60/min, IV bolus norepinephrine 5-10 mcg with atropine 0.01 mg/kg

    Standard intraoperative monitor and non-invasive continuous arterial pressure waveforms (ClearSight) are set up in this group. ClearSight data and HPI derived from ClearSight are used for recording, and are masked for attending anesthesiologists. Blood pressure is monitored with conventional non-invasive blood pressure (NIBP). Attending anesthesiologists controlled the blood pressure according to continuous arterial pressure values. Maintain mean arterial pressure (MAP) above 65 mmHg MAP < 65mmHg and heart rate > 60/min, IV bolus norepinephrine 5-10 mcg MAP < 65mmHg and heart rate < 60/min, IV bolus norepinephrine 5-10 mcg with atropine 0.01 mg/kg

    Outcomes

    Primary Outcome Measures

    time-weighted MAP below 65 mmHg

    Secondary Outcome Measures

    rates of parturients with intraoperative hypotension
    hypotension is defined as MAP below 65 mmHg for more than 1 minute
    total hypotension duration
    hypotension is defined as MAP below 65 mmHg for more than 1 minute
    area under curve of hypotension
    hypotension is defined as MAP below 65 mmHg for more than 1 minute
    total vasopressor dosage
    average norepinephrine dosage used during the surgery
    rate of hypotension related symptoms and sign of the parturients
    symptoms and signs include nausea, vomiting, bradycardia, dizziness, and shivering
    average regional cerebral oxygen saturation

    Full Information

    First Posted
    December 11, 2022
    Last Updated
    December 27, 2022
    Sponsor
    National Taiwan University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05667584
    Brief Title
    Comparisons of Blood Pressure Control Ability Between HPI, ClearSight, and Conventional NIBP During Neuraxial Anesthesia in Cesarean Section
    Official Title
    Comparisons of the Blood Pressure Control Ability Between Hypotension Prediction Index With Non-invasive Continuous Arterial Pressure Waveforms, Continuous Blood Pressure Monitoring With Non-invasive Continuous Arterial Pressure Waveforms, and Intermittent Blood Pressure Monitoring With Conventional Non-invasive Blood Pressureduring Neuraxial Anesthesia in Cesarean Section: a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 2023 (Anticipated)
    Primary Completion Date
    December 2024 (Anticipated)
    Study Completion Date
    December 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    National Taiwan University Hospital

    4. Oversight

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

    5. Study Description

    Brief Summary
    The goal of this study is to compare the blood pressure control ability with HPI, ClearSight, and conventional NIBP during neuraxial anesthesia in cesarean section. The main question it aims to answer is: Anesthesiologists can have a better control of blood pressure during cesarean section with HPI than with conventional NIBP. During the surgery, the participants will be monitored with standard monitor and HPI with ClearSight and will be randomly assigned to three groups, including HPI group, ClearSight group, and NIBP group. Anesthesiologists will treat intraoperative hypotension with different protocols according to the participants' allocation. Investigators will compare the time-weighted average mean arterial pressure < 65mmHg with in three groups. Secondary outcomes includes the intraoperative hypotension rate, total duration of hypotension, the hypotension symptoms and signs of parturients.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Intraoperative Hypotension, Cesarean Section

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    255 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    HPI
    Arm Type
    Experimental
    Arm Description
    Standard intraoperative monitor and non-invasive continuous arterial pressure waveforms (ClearSight) are set up in this group. ClearSight data and hypotension prediction index (HPI) derived from ClearSight are used for recording and monitoring. Blood pressure is monitored with ClearSight and HPI. Attending anesthesiologists controlled the blood pressure according to HPI values. Maintain HPI below 85 HPI > 85 and heart rate > 60/min, IV bolus norepinephrine 5-10 mcg HPI > 85 and heart rate < 60/min, IV bolus norepinephrine 5-10 mcg with atropine 0.01 mg/kg
    Arm Title
    ClearSight
    Arm Type
    Active Comparator
    Arm Description
    Standard intraoperative monitor and non-invasive continuous arterial pressure waveforms (ClearSight) are set up in this group. ClearSight data and HPI derived from ClearSight are used for recording, and HPI are masked for attending anesthesiologists. Blood pressure is monitored with ClearSight. Attending anesthesiologists controlled the blood pressure according to continuous arterial pressure values. Maintain mean arterial pressure (MAP) above 65 mmHg MAP < 65mmHg and heart rate > 60/min, IV bolus norepinephrine 5-10 mcg MAP < 65mmHg and heart rate < 60/min, IV bolus norepinephrine 5-10 mcg with atropine 0.01 mg/kg
    Arm Title
    NIBP
    Arm Type
    No Intervention
    Arm Description
    Standard intraoperative monitor and non-invasive continuous arterial pressure waveforms (ClearSight) are set up in this group. ClearSight data and HPI derived from ClearSight are used for recording, and are masked for attending anesthesiologists. Blood pressure is monitored with conventional non-invasive blood pressure (NIBP). Attending anesthesiologists controlled the blood pressure according to continuous arterial pressure values. Maintain mean arterial pressure (MAP) above 65 mmHg MAP < 65mmHg and heart rate > 60/min, IV bolus norepinephrine 5-10 mcg MAP < 65mmHg and heart rate < 60/min, IV bolus norepinephrine 5-10 mcg with atropine 0.01 mg/kg
    Intervention Type
    Device
    Intervention Name(s)
    hypotension prediction index derived from non-invasive arterial pressure waveforms
    Intervention Description
    The Hypotension Prediction Index (HPI) is an algorithm based on the complex analysis of features in high-fidelity arterial pressure waveform recordings developed to observe subtle signs that could predict the onset of hypotension in surgical and intensive care unit patients. HPI is a unitless number that ranges from 1 to 100, and as the number increases, the likelihood of a hypotensive event (MAP <65 mm Hg for more than 1 minute) occurring in the near future increases. In a validation study on HPI conducted in patients under general anesthesia, the algorithm, at its optimal value, predicted hypotension with both sensitivity and specificity of 86% 5 minutes before the event. Measurement of the arterial pressure waveforms using a finger cuff (ClearSight) is well established.
    Intervention Type
    Device
    Intervention Name(s)
    non-invasive arterial pressure waveforms
    Intervention Description
    ClearSight is a non-invasive hemodynamic monitoring device using digital-cuff and volume-clamp technology to obtain a continuous arterial blood pressure waveform. Continuous finger blood pressure measurement is established by wrapping the cuff around the middle phalanx of a finger. The area under the waveform curve is analyzed using a unique algorithm that serves to calculate the arterial blood pressure, stroke volume (SV) and CO.
    Primary Outcome Measure Information:
    Title
    time-weighted MAP below 65 mmHg
    Time Frame
    through the surgery completion, an average of 1.5 hours
    Secondary Outcome Measure Information:
    Title
    rates of parturients with intraoperative hypotension
    Description
    hypotension is defined as MAP below 65 mmHg for more than 1 minute
    Time Frame
    through the surgery completion, an average of 1.5 hours
    Title
    total hypotension duration
    Description
    hypotension is defined as MAP below 65 mmHg for more than 1 minute
    Time Frame
    through the surgery completion, an average of 1.5 hours
    Title
    area under curve of hypotension
    Description
    hypotension is defined as MAP below 65 mmHg for more than 1 minute
    Time Frame
    through the surgery completion, an average of 1.5 hours
    Title
    total vasopressor dosage
    Description
    average norepinephrine dosage used during the surgery
    Time Frame
    through the surgery completion, an average of 1.5 hours
    Title
    rate of hypotension related symptoms and sign of the parturients
    Description
    symptoms and signs include nausea, vomiting, bradycardia, dizziness, and shivering
    Time Frame
    through the surgery completion, an average of 1.5 hours
    Title
    average regional cerebral oxygen saturation
    Time Frame
    through the surgery completion, an average of 1.5 hours

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 20 - 50 year-old parturients scheduled cesarean delivery neuraxial anesthesia Exclusion Criteria: parturients with preeclampsia parturients with cardiovascular disease above NYHA functional class 2 parturients with arrhythmias, preoperative severe hypertension, or other severe cardiopulmonary diseases. severe perioperative arrhythmias with or without hemodynamic instability failed neuraxial anesthesia or regional blockade level below T6
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Po-Yuan Shih, MD
    Phone
    886-2-23123456
    Ext
    262158
    Email
    shih.poyuan@gmail.com

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    34591796
    Citation
    Frassanito L, Sonnino C, Piersanti A, Zanfini BA, Catarci S, Giuri PP, Scorzoni M, Gonnella GL, Antonelli M, Draisci G. Performance of the Hypotension Prediction Index With Noninvasive Arterial Pressure Waveforms in Awake Cesarean Delivery Patients Under Spinal Anesthesia. Anesth Analg. 2022 Mar 1;134(3):633-643. doi: 10.1213/ANE.0000000000005754.
    Results Reference
    background
    PubMed Identifier
    35754365
    Citation
    Misugi T, Juri T, Suehiro K, Kitada K, Kurihara Y, Tahara M, Hamuro A, Nakano A, Koyama M, Mori T, Tachibana D. Non-invasive continuous blood pressure monitoring using the ClearSight system for pregnant women at high risks of post-partum hemorrhage: comparison with invasive blood pressure monitoring during cesarean section. Obstet Gynecol Sci. 2022 Jul;65(4):325-334. doi: 10.5468/ogs.22063. Epub 2022 Jun 27.
    Results Reference
    background

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    Comparisons of Blood Pressure Control Ability Between HPI, ClearSight, and Conventional NIBP During Neuraxial Anesthesia in Cesarean Section

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