Sparing in Neuromuscular Blockade in COVID 19 ICU

Neuromuscular Blockade Clinical Trial

— TOF-COVID  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04459533
• Other study ID #: 2020_TOF-COVID
• Status: Completed
• Start date: June 1, 2020
• Est. completion date: June 1, 2020

Study information

• Verified date: July 2020
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: June 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
France	Department of Anesthesiology and Intensive Care Medicine, Hôpital de la Croix Rousse, Hospices Civils de Lyon	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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