- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07741851
Monitoring of Neuromuscular Blockade in the Intensive Care Unit: a Reliability Study (CURAREA)
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)
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Aix-en-Provence, France, 13090
- Recrutement
- Centre Hospitalier Intercommunal Aix-Pertuis
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Contact:
- Clinical research manager
- Numéro de téléphone: +33 04.42.33.56.50
- E-mail: rechercheclinique@ch-aix.fr
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Chercheur principal:
- Romain Ronflé, Dr
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: monitoring of muscle relaxation
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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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Proportion of abnormal "train of four" (TOF) responses (TOF ≠ 4 responses) among all evaluations performed on each patient.
Délai: From admission to discontinuation of sedation, for up to 15 days
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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
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From admission to discontinuation of sedation, for up to 15 days
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Comparison of the response to ulnar "TOF" and "PTC" stimulation versus orbicularis "TOF" stimulation in patients under neuromuscular blockade (effectiveness)
Délai: From admission to discontinuation of sedation, for up to 15 days
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The aim is to highlight a correlation between ulnar and orbicularis stimulation
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From admission to discontinuation of sedation, for up to 15 days
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Absence of adverse events during clinical monitoring of neuromuscular blockade:
Délai: From admission to discontinuation of sedation, for up to 15 days
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absence of respiratory effort movements or patient-ventilator asynchrony (safety record)
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From admission to discontinuation of sedation, for up to 15 days
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Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2025-A02564-45
Informations sur les médicaments et les dispositifs, documents d'étude
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