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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Intercommunal Aix-Pertuis

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

160 Participants
are divided into 1 treatment group
Group A: monitoring of muscle relaxationExperimental treatment 1 intervention

Trial outcomes

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

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

Secondary outcomes

1

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

The aim is to highlight a correlation between ulnar and orbicularis stimulation

Time frame
From admission to discontinuation of sedation, for up to 15 days
2

Absence of adverse events during clinical monitoring of neuromuscular blockade:

absence of respiratory effort movements or patient-ventilator asynchrony (safety record)

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

Other outcomes

Sponsors and contacts

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