Shock
Conditions
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.
Interventions
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).
Sponsors
Tao Liu
Tianjin Medical University General Hospital
Xuanwu Hospital, Beijing
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| 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
| 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 |
Outcome results
None listed