An observational study in Critical Care, Mechanical Ventilation and Neuromuscular Blockade, sponsored by French Society for Intensive Care. Completed at 11 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-12-16.
Sponsored by French Society for Intensive Care · Observational
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.
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.
French Society for Intensive Care is the lead sponsor of 13 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients hospitalized in ICU and under mechanical ventilation
Adult Patients hospitalized in an intensive care unit
Administration of a single dose of Succinylcholine or Rocuronium for a rapid-sequence intubation
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
Patient who will receive neuromuscular blockade will be follow during their ICU lenght stay.
Proportion of patients who receive neuromuscular blockade
Proportion between patients who receive neuromuscular blockade and patients hospitalized in ICU and under mechanical ventilation
Time frame: ICU Length stay (usually 7 days)
Indications of neuromuscular blockade
Description of indications for neuromuscular blockade
Time frame: ICU Length stay (usually 7 days)
Monitoring of neuromuscular blockade
Proportion of patients in whom neuromuscular blockade was monitored
Time frame: ICU Discharge (usually 7 days)
Neuromuscular blocking agents administered dose
Total dose and duration of NMBAs
Time frame: ICU Discharge (usually 7 days)
Tolerance of neuromuscular blocking agents
Acquired ICU weakness, pressure ulcer, ventilator associated pneumonia, other potential side effects neuromuscular blocking agents
Time frame: ICU Discharge (usually 7 days)
Number of tracheostomy
Proportion of patients who received tracheostomy during their ICU stay
Time frame: ICU Discharge (usually 7 days)
Duration of ICU stay
Duration of ICU stay
Time frame: ICU Discharge (usually 7 days)
Duration of mechanical ventilation
Duration of mechanical ventilation
Time frame: Time from intubation to successfull extubation (usually 5 days)
ICU Mortality
Proportion of patients dead during their ICU length stay
Time frame: Time of ICU discharge (usually 7 days)
Plan to share: Undecided — IPD can be obtained from PI after careful evaluation of request by clinical research committee of the French Intensive Care Society
This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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French Society for Intensive Care