Development and Validation of an Android-based Application for Anaesthesia Neuromuscular Monitoring

NCT03605225 | Completed

• 1 other identifier: APP NMM
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The present study aims to assess the accuracy of a newly developed Android Smartphone Application in measuring the degree of Neuromuscular block in the perioperative period. This will be achieved by comparing Train-of-four Ratio measurements using this application with those obtained from a standard commercialized neuromuscular monitor.

Conditions

Neuromuscular Blockade; Neuromuscular Monitoring

Keywords

Android application; Anesthesia; intraoperative

Outcome Measures

Primary Outcomes (1)

• Train of Four ratio

  Ratio between de fourth and first accelerometric twitches of the thumb after elicited contraction via transcutaneous electrical stimulation of the ulnar nerve.

  before neuromuscular blocking drug administration, approximately 15 minutes after administration, and before extubation.

Study Arms (2)

Cellphone application

EXPERIMENTAL

Train of Four (TOF) ratio displayed by the Cellphone Application

Device: mobile cellphone application test

Draeger TOF Scan

ACTIVE COMPARATOR

Train of Four (TOF) ratio displayed by the Draeger TOF Scan

Device: mobile cellphone application test

Interventions

mobile cellphone application test DEVICE

Placement of cellphone on the patient´s hand and recording accelerometric data during elicited muscular contractions.

Cellphone application; Draeger TOF Scan

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anaesthesiology (ASA) physical status classification I to III
• elective procedures under general anesthesia requiring use of a non-depolarizing neuromuscular blocking agent

You may not qualify if:

• Known or suspected central or peripheral neuropathies of any ethology
• Muscular dystrophies
• Skin burns and trauma at measurement sites (arms).
• Musculo-tendinopathies of the arms and hands.
• All conditions that might be judged to alter appropriate peripheral neuromuscular conduction.
• Fragile skin impeding placement of electrocardiogram electrodes at measurement sites.
• Allergy to ECG Electrodes
• Intra-operative position impeding proper use of any of the two used neuromuscular monitors.
• Calibration/device failure
• Failure to properly stabilize the patient's hand in supination (so that the smartphone won't dislocate itself during measurements)
• Patient premedication judged to interfere with proper cognitive assimilation of the study concept.

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

universitair Ziekenhuis brussel

Jette, België, 1090, Belgium

Location

Related Publications (1)

• Verdonck M, Carvalho H, Berghmans J, Forget P, Poelaert J. Exploratory Outlier Detection for Acceleromyographic Neuromuscular Monitoring: Machine Learning Approach. J Med Internet Res. 2021 May 31;23(6):e25913. doi: 10.2196/25913.

  PMID: 34152273 DERIVED

Study Officials

• Hugo Carvalho, MSc, MD

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

• Jan D'Haese, MD

  Universitair Ziekenhuis Brussel

  STUDY CHAIR

• Jan Poelaert, PhD, MD

  Universitair Ziekenhuis Brussel

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2018
• First Posted: July 30, 2018
• Study Start: February 7, 2018
• Primary Completion: July 17, 2018
• Study Completion: November 16, 2018
• Last Updated: November 18, 2025

Record last verified: 2025-11

Locations

BE (1)