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

Acute Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05618535
• Other study ID #: EBPHPAIS-URT
• Status: Completed
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: February 2024
• Source: The First Hospital of Jilin University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Device:
• Transcranial Doppler.
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.

Locations

Country	Name	City	State
China	The First Hospital of Jilin University	Changchun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
Yi Yang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in blood pressure variability(BPV)between different positions	BPV is defined as blood pressure oscillations in relation to the mean values.	0-7 days
Primary	Differences in heart rate variability (HRV) between different positions	HRV is defined as heart rate oscillations in relation to the mean values.	0-7 days
Secondary	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.	0-7 days