Sparing in Neuromuscular Blockade in COVID 19 ICU

Completed

• Conditions: Neuromuscular Blockade; Human Characteristics; Complication of Medical Care; Intensive Care Unit Acquired Weakness
• Interventions: Device: TOF protocol

• Registration Number: NCT04459533
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-01
• Primary Completion: 2020-06-01
• Study Completion: 2020-06-01
• Study First Submitted: 2020-06-22
• Status Verified: 2020-07
• Study First Submitted QC: 2020-07-03
• Last Update Submitted: 2020-07-03
• Study First Posted: 2020-07-07
• Last Update Posted: 2020-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

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

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Exclusion Criteria

• Pregnancy
• extracorporeal membrane oxygenation (ECMO)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TOF group	TOF protocol	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).

Primary Outcome Measures

Name	Time	Method
NMB agents consumption	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).

Trial Locations

Locations (1)

Department of Anesthesiology and Intensive Care Medicine, Hôpital de la Croix Rousse, Hospices Civils de Lyon; 🇫🇷 Lyon, France