Tokyo, Aug. 21 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062636) titled 'A Study of the Effects of Electrical Muscle Stimulation on Leg Venous Blood Flow During Upright Positioning in Critically Ill Patients' on Aug. 20.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - Hitachi General Hospital

Condition: Condition - Critically ill adult patients admitted to an intensive care unit who are unable to undergo early mobilization Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To evaluate the effect of adding electrical muscle stimulation to cardiac chair positioning on the change in common femoral vein blood flow from 15 minutes of supine rest to 3 minutes after cardiac chair positioning, compared with cardiac chair positioning alone, in critically ill adult patients who are unable to undergo early mobilization in the intensive care unit. The study will also explore the associations of baseline thigh muscle mass and changes in blood pressure with changes in common femoral vein blood flow, and will estimate effect sizes and variability for a future confirmatory trial. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - AB sequence. Electrical muscle stimulation plus cardiac chair positioning followed by a washout period and then cardiac chair positioning alone.

Treatment A. After 15 minutes of supine rest, electrical muscle stimulation will be initiated using a belt electrode skeletal muscle electrical stimulation device called G TES. Stimulation will be delivered continuously at a frequency of 4 Hz and a pulse width of 250 microseconds. The stimulation intensity will be adjusted to produce visible muscle contractions. After 10 minutes of stimulation in the supine position, cardiac chair positioning will be applied while electrical muscle stimulation is continued. Cardiac chair positioning will consist of 30 degrees of head of bed elevation combined with 12 degrees of whole bed tilt. Common femoral vein blood flow and blood pressure will be measured 3 minutes after positioning.

A washout period will be provided after Treatment A. Treatment B will be initiated after blood pressure has returned to the baseline value measured after 15 minutes of supine rest.

Treatment B. After 15 minutes of supine rest, cardiac chair positioning consisting of 30 degrees of head of bed elevation combined with 12 degrees of whole bed tilt will be applied without electrical muscle stimulation. Common femoral vein blood flow and blood pressure will be measured 3 minutes after positioning. Both treatments will be conducted on the same day. Interventions/Control_2 - BA sequence. Cardiac chair positioning alone followed by a washout period and then electrical muscle stimulation plus cardiac chair positioning.

Treatment B. After 15 minutes of supine rest, cardiac chair positioning consisting of 30 degrees of head of bed elevation combined with 12 degrees of whole bed tilt will be applied without electrical muscle stimulation. Common femoral vein blood flow and blood pressure will be measured 3 minutes after positioning.

A washout period will be provided after Treatment B. Treatment A will be initiated after blood pressure has returned to the baseline value measured after 15 minutes of supine rest.

Treatment A. After 15 minutes of supine rest, electrical muscle stimulation will be initiated using a belt electrode skeletal muscle electrical stimulation device called G TES. Stimulation will be delivered continuously at a frequency of 4 Hz and a pulse width of 250 microseconds. The stimulation intensity will be adjusted to produce visible muscle contractions. After 10 minutes of stimulation in the supine position, cardiac chair positioning will be applied while electrical muscle stimulation is continued. Cardiac chair positioning will consist of 30 degrees of head of bed elevation combined with 12 degrees of whole bed tilt. Common femoral vein blood flow and blood pressure will be measured 3 minutes after positioning. Both treatments will be conducted on the same day.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Adult patients aged 18 years or older who are admitted to the intensive care unit at Hitachi General Hospital. 2. Patients primarily managed by the Department of Emergency and Critical Care Medicine. 3. Patients referred for rehabilitation by the Department of Emergency and Critical Care Medicine. 4. Patients who are unable to undergo early mobilization and have an ICU Mobility Scale score of less than 3. 5. Patients for whom written informed consent is obtained from the patient or a legally authorized representative. Key exclusion criteria - 1. Patients capable of early mobilization, defined as an ICU Mobility Scale score of 3 or higher. 2. Patients receiving extracorporeal membrane oxygenation, IMPELLA support, or intra-aortic balloon pumping. 3. Patients with a contraindication to electrical muscle stimulation, including an implanted cardiac pacemaker or skin lesions at the electrode application sites. 4. Patients with active deep vein thrombosis in a lower limb. 5. Patients receiving neuromuscular blocking agents. 6. Patients who decline participation or for whom written informed consent cannot be obtained from the patient or a legally authorized representative. Target Size - 30

Recruitment Status: Recruitment status - Completed Date of protocol fixation - 2026 Year 02 Month 20 Day Date of IRB - 2026 Year 02 Month 20 Day Anticipated trial start date - 2026 Year 02 Month 23 Day Last follow-up date - 2026 Year 07 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071671

Disclaimer: Curated by HT Syndication.