- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus 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)
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
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Aix-en-Provence, Ranska, 13090
- Rekrytointi
- Centre Hospitalier Intercommunal Aix-Pertuis
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Ottaa yhteyttä:
- Clinical research manager
- Puhelinnumero: +33 04.42.33.56.50
- Sähköposti: rechercheclinique@ch-aix.fr
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Päätutkija:
- Romain Ronflé, Dr
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Ennaltaehkäisy
- Jako: Ei käytössä
- Inventiomalli: Yksittäinen ryhmätehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
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Kokeellinen: 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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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Proportion of abnormal "train of four" (TOF) responses (TOF ≠ 4 responses) among all evaluations performed on each patient.
Aikaikkuna: 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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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Comparison of the response to ulnar "TOF" and "PTC" stimulation versus orbicularis "TOF" stimulation in patients under neuromuscular blockade (effectiveness)
Aikaikkuna: 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:
Aikaikkuna: 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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Yhteistyökumppanit ja tutkijat
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
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