Sparing in Neuromuscular Blockade in COVID 19 ICU (TOF-COVID)
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|ClinicalTrials.gov Identifier: NCT04459533|
Recruitment Status : Completed
First Posted : July 7, 2020
Last Update Posted : July 7, 2020
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.
|Condition or disease||Intervention/treatment|
|Neuromuscular Blockade Human Characteristics Complication of Medical Care Intensive Care Unit Acquired Weakness||Device: TOF protocol|
|Study Type :||Observational|
|Actual Enrollment :||250 participants|
|Official Title:||The Use of Neuromuscular Blockade Monitor as a Strategy for Neuromuscular Blockade Agents Saving in ICU COVID-19 Patients|
|Actual Study Start Date :||June 1, 2020|
|Actual Primary Completion Date :||June 1, 2020|
|Actual Study Completion Date :||June 1, 2020|
COVID-19 patients admitted to the ICU, receiving mechanical ventilation and NMB agents, for whom a NMB monitor use (TOF) was reported in the electronic health records (EHR).
Device: TOF protocol
To 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:
COVID-19 patients admitted to the ICU, receiving mechanical ventilation and NMB agents, with no NMB monitor use reported in the EHR
- NMB agents consumption [ Time Frame: ICU discharge an average of 4 weeks ]We measured the total NMB agents consumption during the stay: cisatracurium and/or atracurium (milligram). Nurses report continuous infusion rates of NMB agents. By extracting this data we were able to retrieve the total approximate dose (we're missing the bolus doses).
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04459533
|Department of Anesthesiology and Intensive Care Medicine, Hôpital de la Croix Rousse, Hospices Civils de Lyon|
|Lyon, France, 69004|