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

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

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.

Study Overview

• Status: Completed
• Conditions: Neuromuscular Blockade; Intensive Care Unit Acquired Weakness; Human Characteristics; Complication of Medical Care
• Intervention / Treatment: Device: TOF protocol

• Study Type: Observational
• Enrollment (Actual): 250

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69004
    • Department of Anesthesiology and Intensive Care Medicine, Hôpital de la Croix Rousse, Hospices Civils de Lyon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NMB agents consumption	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).	ICU discharge an average of 4 weeks

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Actual): June 1, 2020
• Study Completion (Actual): June 1, 2020

Study Registration Dates

• First Submitted: June 22, 2020
• First Submitted That Met QC Criteria: July 3, 2020
• First Posted (Actual): July 7, 2020

Study Record Updates

• Last Update Posted (Actual): July 7, 2020
• Last Update Submitted That Met QC Criteria: July 3, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: COVID 19; critical illness; neuromuscular blockade agent; neuromuscular blockade monitor; Train of Four (TOF)
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 2020_TOF-COVID

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No