Ireland
--:--IST
Recruiting Not applicable

Monitoring of Neuromuscular Blockade in the Intensive Care Unit: a Reliability Study

NCT07741851 · tracked via the Priya Life Science France tracker
Sponsor
Centre Hospitalier Intercommunal Aix-Pertuis
Phase
Not applicable
Started
2026-04-02
Last updated
2026-08-03

Condition(s) studied

Neuromuscular Blockade Monitoring

Investigational drug(s) / intervention(s)

neuromuscular blockade monitoring

neuromuscular blockade monitoring: The goal of monitoring neuromuscular blockade in an intensive care patient is to ensure the effectiveness of the technique through adequate neuromuscular blockade. In addition to a clinical assessment based on observation of respiratory effort or detection of patient-ventilator asynchrony, this monitoring includes the use of quantitative methods with TOFscan Idmed device to evaluate neuromuscular blockade: "TOF" and "PTC." The use of neuromuscular blocking agents and their monitoring are governed by a standard care protocol in each participating center. The investigators will study, within the context of routine care, the reliability and reproducibility of this technique, which was initially applied and validated in patients in the operating room and subsequently adapted for use in intensive care patients.

Study summary

The objective of this clinical trial is to evaluate the reliability of neuromuscular blockade monitoring in adult intensive care patients depending on the clinical context.

The main questions it aims to answer are as follows:

* Detection of an anomaly at ulnar "TOF" stimulation in patients without neuromuscular blockade
* Absence of adverse events during clinical monitoring of neuromuscular blockade (every 24 hours): absence of respiratory effort movements or patient-ventilator asynchrony (safety)

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Adult patients * Patients admitted to the intensive care unit who have been receiving neuromuscular blocking agents for at least 24 hours during their stay - Consent obtained from the patient or emergency consent obtained from family members * Patients covered by the French social security system, regardless of the specific plan Exclusion Criteria: * Patients who have already been exposed to prolonged neuromuscular blockade or who have been receiving continuous neuromuscular blockade for less than 24 hours * Allergy to neuromuscular blocking agents * Patients with a neurological condition that alters the interpretation of neuromuscular blockade or contraindicates the use of neuromuscular blocking agents * Patients enrolled in an interventional study * Patients who object to the collection of their medical data for this study * Patients under the age of 18 * Patients deprived of their liberty, under guardianship, or under conservatorship * Pregnant or breastfeeding women

Primary outcome measure(s)

  • Proportion of abnormal "train of four" (TOF) responses (TOF ≠ 4 responses) among all evaluations performed on each patient. — From admission to discontinuation of sedation, for up to 15 days
    TOF stimulation is one of the most commonly used types of stimulation; it consists of four stimuli (each lasting 200 μs) spaced 0.5 seconds apart. Without neuromuscular blockade, the expected answer in intensive care patients are 4 out of 4

Trial sites (1)

FacilityCityRegionStatus
Centre Hospitalier Intercommunal Aix-Pertuis Aix-en-Provence France Recruiting

More Centre Hospitalier Intercommunal Aix-Pertuis trials in France

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07741851 on ClinicalTrials.gov ↗ ← All trials in France