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

Mechanical Ventilation Clinical Trial

— CURATIV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04028362
• Other study ID #: 2019-A01378-49
• Status: Completed
• Start date: November 2, 2019
• Est. completion date: April 1, 2020

Study information

• Verified date: December 2021
• Source: French Society for Intensive Care
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 282
• Est. completion date: April 1, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

• 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)

Related Conditions & MeSH terms

• Critical Care
• Mechanical Ventilation
• Neuromuscular Blockade

Intervention

Drug:
• Neuromuscular Blocking Agents
Patient who will receive neuromuscular blockade will be follow during their ICU lenght stay.

Locations

Country	Name	City	State
France	CH d'Argenteuil	Argenteuil
France	CHD Les Oudairies	la Roche sur Yon
France	CH de Versailles	Le Chesnay
France	CHU Kremlin-Bicetre	Le Kremlin-Bicêtre
France	CH Le Mans	Le Mans
France	CHU Nantes	Nantes
France	CHU Nimes	Nîmes
France	CHR Orléans	Orléans
France	CHU La Pitié Salpétrière	Paris
France	CH de Pontoise	Pontoise
France	CHRU Bretonneau	Tours

Sponsors (1)

Lead Sponsor	Collaborator
French Society for Intensive Care

Country where clinical trial is conducted

France, 

References & Publications (5)

Arroliga A, Frutos-Vivar F, Hall J, Esteban A, Apezteguía 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. — View 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. — View 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. Erratum in: JAMA. 2016 Jul 19;316(3):350. JAMA. 2016 Jul 19;316(3):350. — View Citation

Lascarrou JB, Le Gouge A, Dimet J, Lacherade JC, Martin-Lefèvre 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. — View 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, Guérin 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Indications of neuromuscular blockade	Description of indications for neuromuscular blockade	ICU Length stay (usually 7 days)
Secondary	Monitoring of neuromuscular blockade	Proportion of patients in whom neuromuscular blockade was monitored	ICU Discharge (usually 7 days)
Secondary	Neuromuscular blocking agents administered dose	Total dose and duration of NMBAs	ICU Discharge (usually 7 days)
Secondary	Tolerance of neuromuscular blocking agents	Acquired ICU weakness, pressure ulcer, ventilator associated pneumonia, other potential side effects neuromuscular blocking agents	ICU Discharge (usually 7 days)
Secondary	Number of tracheostomy	Proportion of patients who received tracheostomy during their ICU stay	ICU Discharge (usually 7 days)
Secondary	Duration of ICU stay	Duration of ICU stay	ICU Discharge (usually 7 days)
Secondary	Duration of mechanical ventilation	Duration of mechanical ventilation	Time from intubation to successfull extubation (usually 5 days)
Secondary	ICU Mortality	Proportion of patients dead during their ICU length stay	Time of ICU discharge (usually 7 days)