A Proof-of-concept Study of Ultrasound Stimulation of the Neck to Enhance Anti-shock Efficacy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- 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
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Experimental group
干预措施: Low-intensity pulsed ultrasound (Device)
Control group
结局指标
主要结局
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
时间窗: From the start of treatment to 60 minutes after the intervention
The proportion of patients with SBP exceeding 90 mmHg and remaining stable for at least 5 minutes following ultrasound therapy
时间窗: From the start of treatment to 60 minutes after the intervention
次要结局
- 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.(From the start of treatment to 60 minutes after the intervention)
- Total hospitalization costs(3 months)
- The total duration from achieving a blood pressure of ≥90 mmHg after treatment until it stabilizes and subsequently drops back to ≤90 mmHg.(From the start of treatment to 60 minutes after the intervention)
- Time from initiation of LIPUS therapy to patient's SBP exceeding 90 mmHg(From the start of treatment to 60 minutes after the intervention)
- Shock Index (SI) Changes(Before treatment and 60 minutes after treatment)
- Heart Rate Variability (HRV) Changes(Before treatment and 60 minutes after treatment)
- Drug dosages from the initiation of LIPUS therapy until the patient's SBP reaches the effective target(From the start of treatment to 60 minutes after the intervention)
- mRS scores for patients in the follow-up control group and experimental group(3 months)
- Length of Stay in Intensive Care Unit (ICU)(3 months)
研究者
Tao Liu
investigator
The George Institute