A Proof-of-concept Study of Ultrasound Stimulation of the Neck to Enhance Anti-shock Efficacy
ConditionShock
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTao Liu
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Low-intensity pulsed ultrasound
DeviceDuring 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).
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Experimental groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
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 interventionSecondary 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 intervention2
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 intervention3
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 intervention4
Shock Index (SI) Changes
Time frame
Before treatment and 60 minutes after treatmentLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Tao Liu
Lead sponsor
The George Institute
Sponsor institution
Tianjin Medical University General Hospital
Collaborator
Xuanwu Hospital, Beijing
Collaborator
Source ClinicalTrials.gov
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