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Clinical Trials/NCT05618535
NCT05618535
Completed
Not Applicable

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

Yi Yang1 site in 1 country100 target enrollmentDecember 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Ischemic Stroke
Sponsor
Yi Yang
Enrollment
100
Locations
1
Primary Endpoint
Differences in blood pressure variability(BPV)between different positions
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2022
End Date
June 30, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Sponsor
Yi Yang
Responsible Party
Sponsor Investigator
Principal Investigator

Yi Yang

Associated Dean of The First Hospital of Jilin University

The First Hospital of Jilin University

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.

Outcomes

Primary Outcomes

Differences in blood pressure variability(BPV)between different positions

Time Frame: 0-7 days

BPV is defined as blood pressure oscillations in relation to the mean values.

Differences in heart rate variability (HRV) between different positions

Time Frame: 0-7 days

HRV is defined as heart rate oscillations in relation to the mean values.

Secondary Outcomes

  • The difference of middle cerebral artery blood flow velocity between different positions.(0-7 days)

Study Sites (1)

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