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

April 17, 2026 updated by: Tao Liu
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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
Time Frame: From the start of treatment to 60 minutes after the intervention
From the start of treatment to 60 minutes after the intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
Time Frame: From the start of treatment to 60 minutes after the intervention
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.
Time Frame: From the start of treatment to 60 minutes after the intervention
From the start of treatment to 60 minutes after the intervention
Time from initiation of LIPUS therapy to patient's SBP exceeding 90 mmHg
Time Frame: From the start of treatment to 60 minutes after the intervention
From the start of treatment to 60 minutes after the intervention
Shock Index (SI) Changes
Time Frame: Before treatment and 60 minutes after treatment
Before treatment and 60 minutes after treatment
Heart Rate Variability (HRV) Changes
Time Frame: Before treatment and 60 minutes after treatment
Before treatment and 60 minutes after treatment
Drug dosages from the initiation of LIPUS therapy until the patient's SBP reaches the effective target
Time Frame: From the start of treatment to 60 minutes after the intervention
From the start of treatment to 60 minutes after the intervention
mRS scores for patients in the follow-up control group and experimental group
Time Frame: 3 months
3 months
Length of Stay in Intensive Care Unit (ICU)
Time Frame: 3 months
3 months
Total hospitalization costs
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tao Liu

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Xuanwu Hospital, Beijing
Tianjin Medical University General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 3, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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