TwichView-guided Atricurium Dose Adjustment Trial

NCT07807046 | Recruiting FDA Device

• 1 other identifier: PL-202608018-V
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if using a monitor that measures muscle response can lower the amount of muscle relaxant medicine needed in adults who are treated in an intensive care unit (ICU) and need a continuous drip of a muscle relaxant called atracurium for more than 48 hours. The main questions it aims to answer are: Does using the monitor lower the infusion rate and total amount of atracurium given over 72 hours? Does using the monitor lower the complications related to atracurium use? Researchers will compare a group whose dose is guided by a muscle response monitor, aiming for a moderate level of muscle relaxation, to a group whose dose is guided by the usual bedside checks, to see if the monitor lowers the amount of medicine needed while keeping the same quality of care. Participants will: Receive atracurium as a continuous drip as part of their usual ICU treatment Have a small sensor placed on the wrist and hand to measure muscle response, if they are in the monitor group Be checked regularly by a nurse and a respiratory therapist, who will adjust the dose following a written plan Be observed closely for 72 hours, then followed until they leave the hospital .

Conditions

ARDS; TTM; ECMO; Neuromuscular Blockade Monitoring

Keywords

neuromuscular blocking agents; train-of-four (TOF) monitoring; electromyography; acute respiratory distress syndrome; ECMO; Target temperature management

Outcome Measures

Primary Outcomes (1)

• The cumulative dose of atracurium

  The mean cumulative dose of atracurium between the intervention and routine care groups. The dose would be calculated in mg.

  72 hours

Secondary Outcomes (7)

• The mean infusion rate of atracurium

  up to 72 hours

• Mean number of inadequate-paralysis events

  during the first 72 hours

• Survival rate at day 7

  At day 7

• Survival rate at ICU discharge

  at ICU discharge with an average of 21 days

• Rate of ventilator dependence

  at ICU discharge with an average of 21 days

Study Arms (2)

Routine care arm

NO INTERVENTION

TOF-guided Intervention arm

EXPERIMENTAL

Device: EMG-based quantitative TOF-guided atracurium titration

Interventions

EMG-based quantitative TOF-guided atracurium titration DEVICE

Before the loading dose is given, the stimulating electrode is placed according to the protocol, and a baseline TOF measurement is obtained. A determined current of 70 mA or higher prompts electrode repositioning and repeat calibration. TOF is measured every 10 minutes during titration and every hour once the target is reached, and 10 minutes after every dose adjustment. A TOF count of 0 to 1 prompts a decrease in infusion rate, a TOF count of 2 to 3 prompts no change, and any detectable TOF ratio prompts a bolus followed by an increase in infusion rate. Adjustment increments are weight-stratified: 0.5 mL bolus and 0.5 mL per hour for participants under 80 kg, and 1 mL bolus and 1 mL per hour for participants 80 kg or over, using atracurium at 10 mg/mL. The infusion rate is capped at 20 micrograms per kilogram per minute. Titration continues for 72 hours

Also known as: Tran-of-four, TwichView

TOF-guided Intervention arm

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult ICU patients (≥ 20 years of age) requiring continuous atracurium infusion for more than 48 hours due to any of the following conditions:
• Moderate-to-severe ARDS (PaO₂/FiO₂ ratio ≤ 150)
• Post-cardiac arrest care with device-controlled TTM (intravascular or surface cooling system)
• Veno-venous (VV) or veno-arterial (VA) ECMO support

You may not qualify if:

• Patients aged under 20 years
• Pregnant patients
• Patients with known allergy to atracurium
• Patients with a do-not-intervention order due to terminal disease
• Patients with severe asthma, owing to the potential for atracurium-induced histamine release
• Patients or their families who refuse to participate in the trial

Sponsors & Collaborators

• Fu Jen Catholic University Hospital: lead

Study Sites (1)

Fu-Jen Catholic University Hospital

New Taipei City, 243, Taiwan

RECRUITING

MeSH Terms

Conditions

Tetralogy of Fallot; Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Central Study Contacts

Herman Chih-Heng Chang, M.D., M.M.S.

CONTACT

+886-29056234; herman90021@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2026
• First Posted: September 8, 2026
• Study Start: August 19, 2026
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: September 8, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)