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

NCT07741851 | Recruiting DMC

• 1 other identifier: 2025-A02564-45
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Neuromuscular Blockade Monitoring

Keywords

intensive care; neuromusculare blockade monitoring; cisatracurium; TOF

Outcome Measures

Primary Outcomes (1)

• Proportion of abnormal "train of four" (TOF) responses (TOF ≠ 4 responses) among all evaluations performed on each patient.

  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

  From admission to discontinuation of sedation, for up to 15 days

Secondary Outcomes (2)

• Comparison of the response to ulnar "TOF" and "PTC" stimulation versus orbicularis "TOF" stimulation in patients under neuromuscular blockade (effectiveness)

  From admission to discontinuation of sedation, for up to 15 days

• Absence of adverse events during clinical monitoring of neuromuscular blockade:

  From admission to discontinuation of sedation, for up to 15 days

Study Arms (1)

monitoring of muscle relaxation

EXPERIMENTAL

Device: neuromuscular blockade monitoring

Interventions

neuromuscular blockade monitoring DEVICE

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.

monitoring of muscle relaxation

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Intercommunal Aix-Pertuis: lead

Study Sites (1)

Centre Hospitalier Intercommunal Aix-Pertuis

Aix-en-Provence, 13090, France

RECRUITING

MeSH Terms

Interventions

Neuromuscular Monitoring

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: July 15, 2026
• First Posted: August 3, 2026
• Study Start: April 2, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: August 3, 2026

Record last verified: 2026-07

Locations

FR (1)