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Effect of Body Position on Hemodynamics in Patients With Acute Ischemic Stroke Undergoing Ultra-early Reperfusion Therapy

Primary Purpose

Acute Ischemic Stroke

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Transcranial Doppler.
Sponsored by
Yi Yang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Ischemic Stroke

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age≥18 years, < 80 years, regardless of sex； Patients with clinically confirmed acute ischemic stroke who received intravenous thrombolysis or emergency endovascular treatment; Baseline National Institute of Health stroke scale（NIHSS）score ≤25; Baseline Glasgow Coma Scale (GCS) ≥8; Signed and dated informed consent is obtained Exclusion Criteria: The patient has clear indications or contraindications, such as active vomiting, spinal cord injury； Clinicians considered that the assigned body position could not be maintained; Patients unable to cooperate with all noninvasive beat-by-beat continuous BP monitoring; Poor temporal window penetration; Patients with diseases that seriously affect hemodynamics, such as atrial fibrillation, anemia, and hyperthyroidism; Previous history of atrial fibrillation or ECG showing atrial fibrillation or arrhythmia; Pregnant or lactating women; Poor treatment compliance; Complicated with severe systemic diseases, such as heart failure, respiratory failure, renal failure, gastrointestinal bleeding, coagulopathy, malignant tumors.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Sham Comparator

    Experimental

    Arm Label

    Zero position

    30 degrees position

    Arm Description

    All monitoring was done from 9 to 11 a.m., and the whole monitoring process was carried out in a specific and quiet environment at 20-24℃ to avoid other auditory and visual stimuli. After 10min of the relaxed supine position, the blood pressure, heart rate, and blood flow velocity of the middle cerebral artery were measured in the 0° position for 5min.

    Within 30 seconds after the 0° position measurement completion, the subjects were transferred to the 30° position and rested for 15 minutes under the 30° position. In other words, a washout period of 15 minutes was established between two measurements to ensure the stability of vital signs and avoid confounding effects. The blood pressure, heart rate, and blood flow velocity of the middle cerebral artery were measured again for 5 minutes after the vital signs were stable.

    Outcomes

    Primary Outcome Measures

    Differences in blood pressure variability（BPV）between different positions
    BPV is defined as blood pressure oscillations in relation to the mean values.
    Differences in heart rate variability (HRV) between different positions
    HRV is defined as heart rate oscillations in relation to the mean values.

    Secondary Outcome Measures

    The difference of middle cerebral artery blood flow velocity between different positions.
    Continuous cerebral blood flow velocities of bilateral middle cerebral artery will be assessed noninvasively using transcranial Doppler.

    Full Information

    First Posted
    November 10, 2022
    Last Updated
    November 10, 2022
    Sponsor
    Yi Yang
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05618535
    Brief Title
    Effect of Body Position on Hemodynamics in Patients With Acute Ischemic Stroke Undergoing Ultra-early Reperfusion Therapy
    Official Title
    Effect of Body Position on Hemodynamics in Patients With Acute Ischemic Stroke Undergoing Ultra-early Reperfusion Therapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 1, 2022 (Anticipated)
    Primary Completion Date
    October 1, 2023 (Anticipated)
    Study Completion Date
    December 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Yi Yang

    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 aim of this study was to determine the differences in hemodynamics between different positions in patients undergoing ultra-early reperfusion therapy.
    Detailed Description
    Hemodynamic stability can prevent hypoperfusion or hyperperfusion after reperfusion therapy. It has been reported in a large number of literatures that body position has an effect on hemodynamics, but the effect of different body positions on the hemodynamics of patients undergoing ultra-early reperfusion therapy is not clear. In this study, we hypothesized that the hemodynamics of patients undergoing ultra-early reperfusion therapy would differ between different positions.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Ischemic Stroke

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Sequential Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Zero position
    Arm Type
    Sham Comparator
    Arm Description
    All monitoring was done from 9 to 11 a.m., and the whole monitoring process was carried out in a specific and quiet environment at 20-24℃ to avoid other auditory and visual stimuli. After 10min of the relaxed supine position, the blood pressure, heart rate, and blood flow velocity of the middle cerebral artery were measured in the 0° position for 5min.
    Arm Title
    30 degrees position
    Arm Type
    Experimental
    Arm Description
    Within 30 seconds after the 0° position measurement completion, the subjects were transferred to the 30° position and rested for 15 minutes under the 30° position. In other words, a washout period of 15 minutes was established between two measurements to ensure the stability of vital signs and avoid confounding effects. The blood pressure, heart rate, and blood flow velocity of the middle cerebral artery were measured again for 5 minutes after the vital signs were stable.
    Intervention Type
    Device
    Intervention Name(s)
    Transcranial Doppler.
    Intervention Description
    Spontaneous arterial blood pressure will be simultaneously recorded using a servo-controlled plethysmograph on the left or right middle finger with an appropriate finger cuff size. Continuous cerebral blood flow velocities of bilateral middle cerebral artery will be assessed noninvasively using transcranial Doppler.
    Primary Outcome Measure Information:
    Title
    Differences in blood pressure variability（BPV）between different positions
    Description
    BPV is defined as blood pressure oscillations in relation to the mean values.
    Time Frame
    0-7 days
    Title
    Differences in heart rate variability (HRV) between different positions
    Description
    HRV is defined as heart rate oscillations in relation to the mean values.
    Time Frame
    0-7 days
    Secondary Outcome Measure Information:
    Title
    The difference of middle cerebral artery blood flow velocity between different positions.
    Description
    Continuous cerebral blood flow velocities of bilateral middle cerebral artery will be assessed noninvasively using transcranial Doppler.
    Time Frame
    0-7 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age≥18 years, < 80 years, regardless of sex； Patients with clinically confirmed acute ischemic stroke who received intravenous thrombolysis or emergency endovascular treatment; Baseline National Institute of Health stroke scale（NIHSS）score ≤25; Baseline Glasgow Coma Scale (GCS) ≥8; Signed and dated informed consent is obtained Exclusion Criteria: The patient has clear indications or contraindications, such as active vomiting, spinal cord injury； Clinicians considered that the assigned body position could not be maintained; Patients unable to cooperate with all noninvasive beat-by-beat continuous BP monitoring; Poor temporal window penetration; Patients with diseases that seriously affect hemodynamics, such as atrial fibrillation, anemia, and hyperthyroidism; Previous history of atrial fibrillation or ECG showing atrial fibrillation or arrhythmia; Pregnant or lactating women; Poor treatment compliance; Complicated with severe systemic diseases, such as heart failure, respiratory failure, renal failure, gastrointestinal bleeding, coagulopathy, malignant tumors.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yi Yang, MD,PhD
    Phone
    0086-13756661217
    Email
    doctoryang@163.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Zhenni Guo, MD,PhD
    Phone
    043188782080
    Email
    zhen1ni2@163.com

    12. IPD Sharing Statement

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    Effect of Body Position on Hemodynamics in Patients With Acute Ischemic Stroke Undergoing Ultra-early Reperfusion Therapy

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