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Completed

NCT Number: NCT05618535

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

The aim of this study was to determine the differences in hemodynamics between different positions in patients undergoing ultra-early reperfusion therapy.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Hospital of Jilin University

Changchun, Jilin, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transcranial Doppler.

Device

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 outcomes

  1. 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.

  2. 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

  1. The difference of middle cerebral artery blood flow velocity between different positions.

    Time frame: 0-7 days

    Continuous cerebral blood flow velocities of bilateral middle cerebral artery will be assessed noninvasively using transcranial Doppler.

Sponsors and collaborators

Lead sponsor

Yi Yang

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 16, 2022
Registry last updated
Mar 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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