Neuromuscular Blockade in the Intentive Care Unit, an Observational Study.

NCT04028362 | Completed

• 1 other identifier: 2019-A01378-49
• Study Type: observational
• Target: 282
• Locations: 1 country
• Sites: 11

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.

Conditions

Critical Care; Mechanical Ventilation; Neuromuscular Blockade

Outcome Measures

Primary Outcomes (1)

• Proportion of patients who receive neuromuscular blockade

  Proportion between patients who receive neuromuscular blockade and patients hospitalized in ICU and under mechanical ventilation

  ICU Length stay (usually 7 days)

Secondary Outcomes (8)

• Indications of neuromuscular blockade

  ICU Length stay (usually 7 days)

• Monitoring of neuromuscular blockade

  ICU Discharge (usually 7 days)

• Neuromuscular blocking agents administered dose

  ICU Discharge (usually 7 days)

• Tolerance of neuromuscular blocking agents

  ICU Discharge (usually 7 days)

• Number of tracheostomy

  ICU Discharge (usually 7 days)

Study Arms (1)

Neuromuscular blockade

Patients who will receive neuromuscular blockade during their ICU length stay will be follow until day 28 or their hospital discharge.

Drug: Neuromuscular Blocking Agents

Interventions

Neuromuscular Blocking Agents DRUG

Patient who will receive neuromuscular blockade will be follow during their ICU lenght stay.

Neuromuscular blockade

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients hospitalized in ICU and under mechanical ventilation

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• French Society for Intensive Care: lead

Study Sites (11)

CH d'Argenteuil

Argenteuil, 95100, France

Location

CHD Les Oudairies

La Roche-sur-Yon, 85925, France

Location

CH de Versailles

Le Chesnay, 78157, France

Location

CHU Kremlin-Bicetre

Le Kremlin-Bicêtre, 94270, France

Location

CH Le Mans

Le Mans, 72037, France

Location

CHU Nantes

Nantes, 44000, France

Location

CHU Nimes

Nîmes, France

Location

CHR Orléans

Orléans, France

Location

CHU La Pitié Salpétrière

Paris, France

Location

CH de Pontoise

Pontoise, 95303, France

Location

CHRU Bretonneau

Tours, 37044, France

Location

Related Publications (6)

• 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.

  PMID: 16100131 BACKGROUND

• 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.

  PMID: 18401254 BACKGROUND

• 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.

  PMID: 26903337 BACKGROUND

• 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.

  PMID: 20843245 BACKGROUND

• 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.

  PMID: 24892266 BACKGROUND

• Hermann B, Decormeille G, Gobe T, Mangeard N, Maamar A, Sayadi S, Pernod B, Robquin N, Ponthus JP, Le Potier S, Bouju P, Balabanian A, Frouin A, Moschietto S, Jacq G, Villemont E, Hoube C, Queyreau A, Morand C, Boissier F, Lascarrou JB, Valera S, Hraiech S, Clouet L, Piton G, Noel C, Joosten A, Tabra Osorio C, Constan A, Cecchini J, Mercier G, Bruyneel A, Villamaux C, Pousset F, Heming N, Poiroux L, Llitjos JF, Barbar SD; SRLF Trial Group. Neuromuscular blockade and their monitoring in the intensive care unit: a multicenter observational prospective study. Ann Intensive Care. 2025 Oct 22;15(1):167. doi: 10.1186/s13613-025-01591-4.

  PMID: 41123780 DERIVED

MeSH Terms

Interventions

Neuromuscular Blocking Agents

Intervention Hierarchy (Ancestors)

Neuromuscular Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2019
• First Posted: July 22, 2019
• Study Start: November 2, 2019
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: December 16, 2021

Record last verified: 2021-12

Locations

FR (11)