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

NCT07467798 | Not Yet Recruiting DMC

• 1 other identifier: Ultrasound Anti-Shock
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Shock

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (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.

  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

Study Arms (2)

Experimental group

EXPERIMENTAL

Device: Low-intensity pulsed ultrasound

Control group

NO INTERVENTION

Interventions

Low-intensity pulsed ultrasound DEVICE

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).

Also known as: LIPUS

Experimental group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Tao Liu: lead
• Tianjin Medical University General Hospital: collaborator
• Xuanwu Hospital, Beijing: collaborator

MeSH Terms

Conditions

Shock

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: investigator

Study Record Dates

• First Submitted: March 3, 2026
• First Posted: March 12, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: April 22, 2026

Record last verified: 2026-04