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

NCT ID: NCT03605225

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-07
• Study Completion Date: 2018-11-16

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.

Detailed Description

Since Harold Randall Griffith pioneered by the use of curare during anaesthesia by administering it to a young man during an appendectomy in Montreal, the practice of anaesthesiology has completely changed and the world of Neuromuscular Blocking has been thoroughly fine-tuned: increased knowledge and clinical experience, development of new Neuromuscular Blocking Agents (NMBA) with fewer side-effects and well-studied pharmacokinetic profiles, introduction of new antagonizing drugs such as Sugammadex, as well as refinement of neuromuscular block measuring instruments. NMBAs are routinely administered to patients in a multiplicity of anaesthetic settings, and the possibility and availability of instruments allowing the accurate measurement of the degree of neuromuscular block has raised the standards of their use and reversal. The absence of a residual neuromuscular blockade is now widely considered an anesthetic must, as incomplete recovery has been long-established as a strong contributor to post-anesthesia morbidity and mortality. Considering the proven inconsistent, inter/intra-variable and inaccurate character of the human senses to estimate adequate neuromuscular recovery after NMBA use, the proper assessment of neuromuscular recovery can only be done by means of objective methods.3 For this purpose, one of the most widely used methods is the Train of Four (TOF): transcutaneous application of a series of 4 square-wave supra-maximal electrical stimuli over the course of a nerve of choice (most commonly the ulnar nerve). These are applied at a frequency of 2Hz, and each with a duration of 0,2ms. These stimuli elicit a motor response on the adductor pollicis muscle, which on its turn dictates the abduction of the thumb. The acceleration of this movement can be followed by means of an uni/multi-directional accelerometer attached to the thumb. The ratio of the acceleration of the 4th and 1st elicited contractions is called the TOF-Ratio, and this TOF-ratio is a clinically and scientifically established method of assessing neuromuscular block recovery. A value of 1 translates a full recovery of the muscular function of a patient. In modern Anesthesia, the bar for deeming a recovery as adequate has been set at a minimum of a TOF-Ratio of >0.9, with some authors advocating a ratio of 1 as the only acceptable and complications-avoiding result.

Although an effective measurement of muscular recovery parameters is necessary, daily clinical limitations dictate other practices. Medical devices are expensive and not always available for immediate use. Some devices are also only able to deliver the electrical impulses, but not to measure acceleromyographic parameters. These limitations often force anaesthesiologists to undertake on-the-spot guess-practices (assuming recovery based on a particular NMBA's half-life and its last administered dose), or "d'office" actions (standard NMBA reversal) to determine if a patient has adequately recovered. These methods are inherently associated with major pitfalls/iatrogenic side-effects and are major determinants of a high post-operative morbidity and mortality.

In this study the investigators aim to assess the capability of a dedicated smartphone application to transform and incorporate a Smartphone's accelerometric data to accurately measure the TOF-Ratio in an anaesthesia setting and to compare it to commercially used and established neuromuscular block measuring devices.

Conditions

Neuromuscular Blockade; Neuromuscular Monitoring

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Cellphone application

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

Group Type: EXPERIMENTAL

mobile cellphone application test

Intervention Type: DEVICE

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

Draeger TOF Scan

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

Group Type: ACTIVE_COMPARATOR

mobile cellphone application test

Intervention Type: DEVICE

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

Interventions

mobile cellphone application test

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitair Ziekenhuis Brussel

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hugo Carvalho, MSc, MD

Role: PRINCIPAL_INVESTIGATOR

Universitair Ziekenhuis Brussel

Jan D'Haese, MD

Role: STUDY_CHAIR

Universitair Ziekenhuis Brussel

Jan Poelaert, PhD, MD

Role: STUDY_DIRECTOR

Universitair Ziekenhuis Brussel

Locations

universitair Ziekenhuis brussel

Jette, België, Belgium

Countries

Belgium

References

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.

Reference Type: DERIVED

PMID: 34152273 (View on PubMed)

Other Identifiers

APP NMM

Identifier Type: -

Identifier Source: org_study_id