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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04459533
Acronym
TOF-COVID
Enrollment
250
Registered
2020-07-07
Start date
2020-06-01
Completion date
2020-06-01
Last updated
2020-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complication of Medical Care, Human Characteristics, Intensive Care Unit Acquired Weakness, Neuromuscular Blockade

Keywords

neuromuscular blockade agent, neuromuscular blockade monitor, Train of Four (TOF), critical illness, COVID 19

Brief 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.

Interventions

DEVICETOF 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: * 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.

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* PCR-proven SARS-CoV-2 infection * Use of VM (mechanical ventilation) * Use of NMB agents for at least 48 hours

Exclusion criteria

* Pregnancy * extracorporeal membrane oxygenation (ECMO)

Design outcomes

Primary

MeasureTime frameDescription
NMB agents consumptionICU discharge an average of 4 weeksWe 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).

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026