Health TrialsbyHealthPanel

TwichView-guided Atricurium Dose Adjustment Trial

ConditionsARDSTTMECMONeuromuscular Blockade Monitoring
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorFu Jen Catholic University Hospital

About this trial

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 .

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patients aged under 20 years

Pregnant patients

Patients with known allergy to atracurium

Patients with a do-not-intervention order due to terminal disease

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Routine care armNo intervention 0 interventions
Group B: TOF-guided Intervention armExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
72 hours

Secondary outcomes

1

The mean infusion rate of atracurium

Mean rate of continuous atracurium infusion (mcg/kg/min) per participant, calculated as the total infused dose divided by body weight and by the duration of infusion.

Time frame
up to 72 hours
2

Mean number of inadequate-paralysis events

Time frame
during the first 72 hours
3

Survival rate at day 7

Time frame
At day 7
4

Survival rate at ICU discharge

Time frame
at ICU discharge with an average of 21 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fu Jen Catholic University Hospital

Lead sponsor

Source ClinicalTrials.gov
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