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RecruitingNCT07741851CURAREAUpdated Aug 3, 2026

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

An interventional study of neuromuscular blockade monitoring in Neuromuscular Blockade Monitoring, sponsored by Centre Hospitalier Intercommunal Aix-Pertuis. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-03.

Sponsored by Centre Hospitalier Intercommunal Aix-Pertuis · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Apr 2026, registered Jul 2026).
  • Started Apr 2026; still recruiting 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
160
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

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)
Read the detailed description

Muscle relaxation in the intensive care unit is a commonly used therapeutic approach, but one that remains controversial due to a debated benefit-risk ratio depending on the clinical context. First, neuromuscular blockade is a common technique in the operating room to facilitate orotracheal intubation or to improve surgical comfort during the procedure.

The French Society of Anesthesia and Intensive Care (SFAR) recommends intraoperative monitoring of neuromuscular blockade and recovery from neuromuscular blockade for patients under general anesthesia who have received neuromuscular blocking agents. It is recommended to use ulnar nerve stimulation at the wrist with visual or tactile assessment of thumb adductor contraction, given the ease of access as well as the potential to quantify the muscular response of this muscle. When deep neuromuscular blockade of the body's most resistant muscles (diaphragm, abdominal wall muscles) is indicated, it is recommended to wait until the four responses to the four-pulse train to the thumb adductor have disappeared and to monitor using Post-Tetanic Count (PTC) stimulation. In this case, the presence of one to five responses to the thumb adductor indicates complete paralysis of the abdominal muscles. Stimulation of the facial nerve in four-pulse trains and visual assessment of the response in the corrugator supercilii muscle is an alternative to the ulnar nerve test. The neuromuscular blockade profile of the corrugator supercilii muscle is comparable to that of the body's most resistant muscles, such as the laryngeal adductors or the diaphragm.

In the intensive care unit, neuromuscular blockade is primarily used for emergency orotracheal intubation and in cases of severe acute respiratory distress syndrome (ARDS). In moderate-to-severe cases, some patients require deep, continuous sedation during the initial phase, sometimes in combination with neuromuscular blockade. Early and continuous infusion of cisatracurium during the initial phase of severe ARDS (P/F \< 150) has demonstrated a clear clinical benefit in terms of 90-day mortality through several pathophysiological mechanisms. However, prolonged use of neuromuscular blockade is also associated with neuromuscular weakness and requires deep sedation, which can itself have negative consequences. Despite the lack of robust evidence, monitoring of neuromuscular blockade is recommended in patients in the intensive care unit. Monitoring the depth of neuromuscular blockade would help ensure that neuromuscular blockade goals are met while using the lowest possible doses of neuromuscular blocking agents.

Clinical assessment based on observation of respiratory effort or detection of patient-ventilator asynchrony should be combined with a quantitative method for evaluating neuromuscular blockade: "Train-of-four" (TOF) or "post-tetanic count" (PTC) . However, no study has examined the feasibility of this technique in our intensive care patients across different clinical contexts. The data have been extrapolated from the operating room, even though the use of neuromuscular blockers in the ICU differs and certain clinical situations may make interpretation of the monitoring results potentially difficult: ICU-acquired neuromyopathy, therapeutic hypothermia, and interstitial edema.

These clinical situations may alter the muscle response to electrical stimulation and thus skew the results of "TOF" or "PTC" monitoring.

The objective of our study is to evaluate the reliability of neuromuscular blockade monitoring in intensive care patients.

02

Conditions studied

  • Neuromuscular Blockade Monitoring

Keywords

  • intensive care
  • neuromusculare blockade monitoring
  • cisatracurium
  • TOF
03

In context

Lead sponsor

Centre Hospitalier Intercommunal Aix-Pertuis is the lead sponsor of 4 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
160 participants (estimated)

Study arms

  • Experimental
    monitoring of muscle relaxation

    Device: neuromuscular blockade monitoring

Interventions

  • Deviceneuromuscular 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.

06

What researchers measure

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

07

Study locations

1 of 1 sites recruiting
  • Centre Hospitalier Intercommunal Aix-Pertuis
    Aix-en-Provence, 13090, France
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07741851
Lead sponsor
Centre Hospitalier Intercommunal Aix-Pertuis
Responsible party
Romain Ronfle (principal investigator, Centre Hospitalier Intercommunal Aix-Pertuis) — Principal investigator
First posted
Aug 3, 2026
Start date
Apr 2, 2026
Primary completion
Jan 2027 (estimated)
Completion
Jan 2027 (estimated)
Last update
Aug 3, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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