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Paired Assessment of Two Electromyographic Neuromuscular Monitors: Stimpod NMX450X Versus Datex-Ohmeda E-NMT

Sponsor
Universitair Ziekenhuis Brussel (Other)
Overall Status
Recruiting
CT.gov ID
NCT04931901
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
2.8
Anticipated Duration (Months)
10.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

After anesthesia is induced, 2 EMG TOFF devices will be placed on the patients arms, one on the right arm, the other on the left. There will be a randomization per dominant hand and nondominant hand for the placing of the devices. The devices are the Stimpod NMX450X and the Datex-Ohmeda E-NMT.

Condition or Disease Intervention/Treatment Phase
  • Device: EMG TOF device
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomization per dominant and nondominant hand. So that there is an even share of number of patients with Stimpod NMX450X on dominant hand and Datex-Ohmeda E-NMT.Randomization per dominant and nondominant hand. So that there is an even share of number of patients with Stimpod NMX450X on dominant hand and Datex-Ohmeda E-NMT.
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Paired Assessment of Two Electromyographic Neuromuscular Monitors: Stimpod NMX450X Versus Datex-Ohmeda E-NMT
Actual Study Start Date :
Sep 6, 2021
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Stimpod NMX450X

Device: EMG TOF device
Use of Stimpod NMX450X as an electromyographic neuromuscular monitor
Active Comparator: Datex-Ohmeda E-NMT

Device: EMG TOF device
Use of Stimpod NMX450X as an electromyographic neuromuscular monitor

Outcome Measures

Primary Outcome Measures

  1. TOF-ratio (percentage) [Up until 120 minutes]

    TOF = Train-of-four. TOF-ratio is the ratio of the fourth muscle response to the first one. This is used to assess neuromuscular transmission. TOF% indicates fade in non-depolarizing block. We are comparing the calculated TOF ratio of the stimpod NMX to the datex-ohmeda E-NMT

Secondary Outcome Measures

  1. TOF-count (absolute number) [Up until 120 minutes.]

    TOF count is the actual number of detected muscle responses. The number that is used to calculate the percentage (TOF-ratio). When the TOF count drops below 4 responses, then the TOF% cannot be calculated. We are comparing the detected muscle responses of the stimpod NMX to the datex-ohmeda E-NMT

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Adult patients (18 years old and above)

  • undergoing General Anaesthesia for noncardiac surgery requiring the use of a neuromuscular blocking agent.

Exclusion Criteria:

  • Use of different types of neuromuscular blocking agents for the same patient within the same surgical procedure.

  • Known Neuromuscular diseases/syndromes judged to condition accurate neuromuscular monitoring.

  • Known acute or chronic hepatic disease.

Contacts and Locations

Locations

Site City State Country Postal Code
1 UZ Brussel Jette Brussel Belgium 1090

Sponsors and Collaborators

  • Universitair Ziekenhuis Brussel

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier:
NCT04931901
Other Study ID Numbers:
  • StimpodVSDatex-Ohmeda
First Posted:
Jun 18, 2021
Last Update Posted:
Nov 9, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Neuromuscular Manifestations

Study Results

No Results Posted as of Nov 9, 2021