Clinical Trials Directory

Trials / Completed

CompletedNCT04459533

Sparing in Neuromuscular Blockade in COVID 19 ICU

The Use of Neuromuscular Blockade Monitor as a Strategy for Neuromuscular Blockade Agents Saving in ICU COVID-19 Patients

Status
Completed
Phase
Study type
Observational
Enrollment
250 (actual)
Sponsor
Hospices Civils de Lyon · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This is a retrospective case-controlled study of the effect of the use of a neuromuscular blockade (NMB) monitor on the consumption of NMB agents in patients under mechanical ventilation in the context of COVID-19. The use of NMB agents during mechanical ventilation in patients with acute respiratory distress syndrome (ARDS) improves respiratory support conditions and reduces mortality. In the context of COVID-19 pandemic, patients with severe forms of the disease hospitalized in intensive care units (ICU) benefit from prolonged mechanical ventilation with frequent use of NMB agents. Large amount of such patient admitted in a short time has led to a shortage of NMB agents, particularly cisatracurium. The use of NMB monitors (for example - Train of Four (TOF)) is a well-established practice in general anesthesia. There is no recommendation for the use of NMB monitor in ICU patients available up to date. However, in the attempt to reduce the consumption of NMB agents a NMB monitoring was used in ICU patients during the COVID-19 pandemic at university hospitals of Hospices Civil de Lyon, with the endorsement of the local College of Anesthetists. The aim of our study is to evaluate if the use of a NMB monitor decreases the consumption of NMB agents in patients under mechanical ventilation in the context of COVID-19.

Conditions

Interventions

TypeNameDescription
DEVICETOF protocolTo the introduction of CISATRACURIUM, Initial bolus was at 0.2mg/kg and initial continuous infusion at 0.18mg/kg/h of theoretical ideal weight. To the introduction of ATRACURIUM, initial bolus was at 0.5mg/kg and initial continuous infusion at 0.5mg/kg/h of theoretical ideal weight. Introduction of NMBA was associated to deep sedation (RASS - 4 or RAMSAY 6; BIS 40 to 60). TOF was measured through the electric stimulation of peripheral nerves (facial or ulnar nerve). The dose of NMB agents was then adapted according to the number of answers to the TOF, per 4 hours: * If 0 response and no respiratory asynchrony: no change in flow rate * If \>=1 or respiratory asynchrony: increase of the continuous curare flow by 20% preceded by a bolus identical to the one administered at the beginning of NMB agent, then recheck at H+1.

Timeline

Start date
2020-06-01
Primary completion
2020-06-01
Completion
2020-06-01
First posted
2020-07-07
Last updated
2020-07-07

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT04459533. Inclusion in this directory is not an endorsement.