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

Not Applicable
Completed
Conditions
Acute Ischemic Stroke
Interventions
Device: Transcranial Doppler.
Registration Number
NCT05618535
Lead Sponsor
Yi Yang
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
100
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SEQUENTIAL
Arm && Interventions
GroupInterventionDescription
Zero positionTranscranial Doppler.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.
30 degrees positionTranscranial Doppler.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.
Primary Outcome Measures
NameTimeMethod
Differences in blood pressure variability(BPV)between different positions0-7 days

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

Differences in heart rate variability (HRV) between different positions0-7 days

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

Secondary Outcome Measures
NameTimeMethod
The difference of middle cerebral artery blood flow velocity between different positions.0-7 days

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

Trial Locations

Locations (1)

The First Hospital of Jilin University

🇨🇳

Changchun, Jilin, China

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