A Proof-of-concept Study of Ultrasound Stimulation of the Neck to Enhance Anti-shock Efficacy

Обзор

The objective of this clinical study is to evaluate the initial efficacy and safety of LIPUS as an adjunct to standard therapy in patients with shock. The investigators will invite patients to participate in a proof-of-concept study investigating the efficacy of neck ultrasound stimulation to enhance anti-shock treatment, involving brief exposure to low-intensity pulsed ultrasound. This study examines whether LIPUS can enhance blood pressure in patients with shock, improve the efficacy of antihypotensive treatment, and reduce the dosage and duration of vasoactive drugs during active pharmacological therapy. By applying LIPUS as an adjunct to conventional treatment in clinical cases of shock, we aim to determine the clinical value of LIPUS and establish a theoretical foundation for developing innovative new therapies for shock.

Вмешательства

• Устройство Low-intensity pulsed ultrasound
  During periods of stable blood pressure, administer cervical ultrasound stimulation (3-minute stimulation followed by a 2-minute interval, repeated cyclically; total stimulation duration not exceeding 60 minutes).

Первичные конечные точки

• The proportion of patients whose SBP exceeded 90 mmHg and remained stable for at least 5 minutes within 5 minutes of receiving LIPUS treatment or control group treatment [Срок оценки: From the start of treatment to 60 minutes after the intervention]

Вторичные конечные точки (9)

• The proportion of cases where blood pressure increased by more than 10,15,or 20 mmHg above pre-treatment levels and remained elevated for at least 5 minutes, along with the duration of elevation. [Срок оценки: From the start of treatment to 60 minutes after the intervention]
• The total duration from achieving a blood pressure of ≥90 mmHg after treatment until it stabilizes and subsequently drops back to ≤90 mmHg. [Срок оценки: From the start of treatment to 60 minutes after the intervention]
• Time from initiation of LIPUS therapy to patient's SBP exceeding 90 mmHg [Срок оценки: From the start of treatment to 60 minutes after the intervention]
• Shock Index (SI) Changes [Срок оценки: Before treatment and 60 minutes after treatment]
• Heart Rate Variability (HRV) Changes [Срок оценки: Before treatment and 60 minutes after treatment]
• Drug dosages from the initiation of LIPUS therapy until the patient's SBP reaches the effective target [Срок оценки: From the start of treatment to 60 minutes after the intervention]
• mRS scores for patients in the follow-up control group and experimental group [Срок оценки: 3 months]
• Length of Stay in Intensive Care Unit (ICU) [Срок оценки: 3 months]
• Total hospitalization costs [Срок оценки: 3 months]

Критерии участия

Критерии включения

• Patients with shock who are ≥18 years of age and have a systolic blood pressure (SBP) between 60 mmHg and 90 mmHg;
• Patients with arterial blood pressure monitoring or peripheral arterial pressure monitoring with intervals of single-digit minutes;
• Patients with mild to moderate shock with a shock index (SI) of 1 ≤ SI ≤ 2;
• Patients with complete medical records.

Критерии исключения

• Patients with unstable condition and estimated survival time <24 hours;
• Patients requiring emergency surgery to achieve control of their condition;
• Perioperative patients requiring surgery due to conditions other than hypotension;
• Pregnant or lactating patients;
• Patients with neck wounds and/or carotid artery plaques who are unsuitable for ultrasound stimulation of the left carotid sinus;
• Patients deemed unsuitable for inclusion by the investigator.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07467798 · Ultrasound Anti-Shock

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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