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

NCT05618535 | Completed DMC

• 1 other identifier: EBPHPAIS-URT
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

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

  0-7 days

Study Arms (2)

Zero position

SHAM COMPARATOR

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.

Device: Transcranial Doppler.

30 degrees position

EXPERIMENTAL

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.

Device: Transcranial Doppler.

Interventions

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.

30 degrees position; Zero position

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yi Yang: lead

Study Sites (1)

The First Hospital of Jilin University

Changchun, Jilin, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Ultrasonography, Doppler, Transcranial

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Echoencephalography; Neuroradiography; Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiography; Ultrasonography; Ultrasonography, Doppler; Diagnostic Techniques, Neurological; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associated Dean of The First Hospital of Jilin University

Study Record Dates

• First Submitted: November 10, 2022
• First Posted: November 16, 2022
• Study Start: December 1, 2022
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: March 1, 2024

Record last verified: 2024-02

Locations

CN (1)