Clinical trial NCT04028362: Neuromuscular Blockade in the Intentive Care Unit, an Observational Study.
Official title: Neuromuscular Blockade in the Intentive Care Unit, an Observational Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Care
Mechanical Ventilation
Neuromuscular Blockade
Lead sponsor: French Society for Intensive Care
Sponsor class: OTHER
First posted: 2019-07-22
Enrollment: 282
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized in ICU and under mechanical ventilation

Brief summary: The study Short description of the protocol intended for the lay public. Include a brief statement of the study hypothesis. (Limit: 5000 characters) Neuromuscular blocking agents (NMBAs) are drug capable of inducing a complete paralysis of the muscle. Their use is frequent in the intensive care unit (ICU). Most of the time it is used as a single infusion to facilitate endotracheal intubation, but in the ICU the use of continuous infusion is common in several pathologies: acute distress respiratory syndrome, post-cardiac arrest survivor under hypothermia to prevent shivering, abdominal compartment syndrome, severe traumatic brain injury with uncontrolled intra-cranial pressure and severe asthma among others.

A monitoring of the dose of NMBAs is recommended to guide the depth of paralysis and to guide recovery, but in the ICU, the interest of such a monitoring during continuous infusion is unclear and the level of evidence is low.

The investigators propose to conduct a prospective multicentric observational study to describe the current practice in the use of NMBAs in mechanically ventilated patients in the ICU. As a primary objective we will describe the prevalence of NMBAs use in the ICU. As a secondary objective, the investigators will investigate the impact of protocol and/or monitoring devices of NMBAs on the dose administered and clinical outcome endpoints.

Detailed description: Neuromuscular blocking agents (NMBAs) are usually administered during anesthesia for endotracheal tube placement or surgical interventions. But their use is also common in the medical intensive care unit (ICU) (1, 2). Together with sedation and analgesia, they are mainly used in continuous infusion in Acute Respiratory Distress Syndrom (ARDS) (3, 4), but also in post-cardiac arrest survivor under hypothermia to prevent shivering (5), in abdominal compartment syndrome (6), in severe traumatic brain injury with uncontrolled intra-cranial pressure (7) and severe asthma among others.

A monitoring of the treatment is recommended (8) and several monitoring techniques exists: qualitative clinical monitoring is known to be inefficient, qualitative clinical monitoring using scores such as the BSAS (9) or monitoring using peripheral nerve stimulation (train-of-four (TOF) (10)) or other devices such as accelerometry or electromyography.

As opposed to their use in the operating room where the interest of the monitoring is proven, there are discrepancy between studies on whether it is useful to monitor NMBAs in the ICU. For instance, Strange et al. did not observe any advantage of the use of a protocol of NMBAs administration (11), and Baumann et al. came to the same conclusions. However, more recently (12), Hraeich et al. found that the monitoring of NMBAs dosage guided by the TOF allowed to significantly reduce the dose administered during ADRS (13).

Thus, in the ICU, although guidelines recommend to monitor NMBAs administration (8), the level of evidence regarding the interest of monitoring and the device to use for such a monitoring is low.

The investigators propose to conduct a prospective multicentric observational study to describe the current practice in the use of NMBAs in mechanically ventilated patients in the ICU. As a primary objective the investigators will describe the prevalence of NMBAs use in the ICU. As a secondary objective, the investigator will investigate the impact of protocol and/or monitoring devices of NMBAs on the dose administered and clinical outcome endpoints, such as in-ICU mortality, duration of mechanical ventilation or acquired neuromyopathy or other complications of NMBAs.

Eligibility criteria: * Inclusion criteria

  * Adult Patients hospitalized in an intensive care unit
  * Patient under invasive mechanical ventilation
  * Administration of at least a single dose of neuromuscular blocking agent
* Exclusion criteria :

  * Administration of a single dose of Succinylcholine or Rocuronium for a rapid-sequence intubation
  * Moribund patient whose life expectancy is less than 24 hours
  * Patient under 18 years old
  * Patient under legal guardianship.
  * Pregnant women
  * Patient already included previously in the study
  * Absence of health insurance in France
  * Neuromuscular blocking agent administered outside the ICU (i.e. in the operating room)

Primary outcomes:
measure: Proportion of patients who receive neuromuscular blockade
timeFrame: ICU Length stay (usually 7 days)
Secondary outcomes:
measure: Indications of neuromuscular blockade
timeFrame: ICU Length stay (usually 7 days)
measure: Monitoring of neuromuscular blockade
timeFrame: ICU Discharge (usually 7 days)
measure: Neuromuscular blocking agents administered dose
timeFrame: ICU Discharge (usually 7 days)
measure: Tolerance of neuromuscular blocking agents
timeFrame: ICU Discharge (usually 7 days)
measure: Number of tracheostomy
timeFrame: ICU Discharge (usually 7 days)
measure: Duration of ICU stay
timeFrame: ICU Discharge (usually 7 days)
measure: Duration of mechanical ventilation
timeFrame: Time from intubation to successfull extubation (usually 5 days)
measure: ICU Mortality
timeFrame: Time of ICU discharge (usually 7 days)
Other outcomes:
Locations:
city: Argenteuil
country: France
facility: CH d'Argenteuil
city: la Roche sur Yon
country: France
facility: CHD Les Oudairies
city: Le Chesnay
country: France
facility: CH de Versailles
city: Le Kremlin-Bicêtre
country: France
facility: CHU Kremlin-Bicetre
city: Le Mans
country: France
facility: CH Le Mans
city: Nantes
country: France
facility: CHU Nantes
city: Nîmes
country: France
facility: CHU Nimes
city: Orléans
country: France
facility: CHR Orléans
city: Paris
country: France
facility: CHU La Pitié Salpétrière
city: Pontoise
country: France
facility: CH de Pontoise
city: Tours
country: France
facility: CHRU Bretonneau
Study officials:
References:
citation: Arroliga A, Frutos-Vivar F, Hall J, Esteban A, Apezteguia C, Soto L, Anzueto A; International Mechanical Ventilation Study Group. Use of sedatives and neuromuscular blockers in a cohort of patients receiving mechanical ventilation. Chest. 2005 Aug;128(2):496-506. doi: 10.1378/chest.128.2.496.
citation: Arroliga AC, Thompson BT, Ancukiewicz M, Gonzales JP, Guntupalli KK, Park PK, Wiedemann HP, Anzueto A; Acute Respiratory Distress Syndrome Network. Use of sedatives, opioids, and neuromuscular blocking agents in patients with acute lung injury and acute respiratory distress syndrome. Crit Care Med. 2008 Apr;36(4):1083-8. doi: 10.1097/CCM.0B013E3181653895.
citation: Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, Ranieri M, Rubenfeld G, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800. doi: 10.1001/jama.2016.0291.
citation: Papazian L, Forel JM, Gacouin A, Penot-Ragon C, Perrin G, Loundou A, Jaber S, Arnal JM, Perez D, Seghboyan JM, Constantin JM, Courant P, Lefrant JY, Guerin C, Prat G, Morange S, Roch A; ACURASYS Study Investigators. Neuromuscular blockers in early acute respiratory distress syndrome. N Engl J Med. 2010 Sep 16;363(12):1107-16. doi: 10.1056/NEJMoa1005372.
citation: Lascarrou JB, Le Gouge A, Dimet J, Lacherade JC, Martin-Lefevre L, Fiancette M, Vinatier I, Lebert C, Bachoumas K, Yehia A, Lagarrigue MH, Colin G, Reignier J. Neuromuscular blockade during therapeutic hypothermia after cardiac arrest: observational study of neurological and infectious outcomes. Resuscitation. 2014 Sep;85(9):1257-62. doi: 10.1016/j.resuscitation.2014.05.017. Epub 2014 Jun 2.