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Sparing in Neuromuscular Blockade in COVID 19 ICU (TOF-COVID)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04459533
Recruitment Status : Completed
First Posted : July 7, 2020
Last Update Posted : July 7, 2020
Information provided by (Responsible Party):
Hospices Civils de Lyon

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.

Condition or disease Intervention/treatment
Neuromuscular Blockade Human Characteristics Complication of Medical Care Intensive Care Unit Acquired Weakness Device: TOF protocol

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Study Type : Observational
Actual Enrollment : 250 participants
Observational Model: Case-Control
Time Perspective: Retrospective
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

Group/Cohort Intervention/treatment
TOF group
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:

  • 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.

Control group
COVID-19 patients admitted to the ICU, receiving mechanical ventilation and NMB agents, with no NMB monitor use reported in the EHR

Primary Outcome Measures :
  1. 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).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
We included all COVID patients in ICU university hospitals in Lyon who required mechanical ventilation and NMB for at least 48 hours.

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04459533

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Department of Anesthesiology and Intensive Care Medicine, Hôpital de la Croix Rousse, Hospices Civils de Lyon
Lyon, France, 69004
Sponsors and Collaborators
Hospices Civils de Lyon
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Responsible Party: Hospices Civils de Lyon Identifier: NCT04459533    
Other Study ID Numbers: 2020_TOF-COVID
First Posted: July 7, 2020    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
neuromuscular blockade agent
neuromuscular blockade monitor
Train of Four (TOF)
critical illness