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NCT Number: NCT07467798

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.

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Key information

Conditions

Shock Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Other names: LIPUS

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

    Time frame: From the start of treatment to 60 minutes after the intervention

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. Shock Index (SI) Changes

    Time frame: Before treatment and 60 minutes after treatment

  5. Heart Rate Variability (HRV) Changes

    Time frame: Before treatment and 60 minutes after treatment

  6. 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

  7. mRS scores for patients in the follow-up control group and experimental group

    Time frame: 3 months

  8. Length of Stay in Intensive Care Unit (ICU)

    Time frame: 3 months

  9. Total hospitalization costs

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Tao Liu

Other

Collaborators

  • Tianjin Medical University General Hospital
  • Xuanwu Hospital, Beijing

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 12, 2026
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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