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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Shock
• Intervention / Treatment: Device: Low-intensity pulsed ultrasound

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group
Experimental: Experimental group	Device: 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).; Other Names: LIPUS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	From the start of treatment to 60 minutes after the intervention

Secondary Outcome Measures

Outcome Measure	Time Frame
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
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
Total hospitalization costs	3 months

Collaborators and Investigators

• Sponsor: Tao Liu
• Collaborators: Xuanwu Hospital, Beijing; Tianjin Medical University General Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: March 3, 2026
• First Submitted That Met QC Criteria: March 11, 2026
• First Posted (Actual): March 12, 2026

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock
• Other Study ID Numbers: Ultrasound Anti-Shock

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No