CompletedNot Applicable

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

Belgium22 participantsStarted 2018-02-07

Plain-language 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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Train of Four ratio

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

Trial details

NCT IDNCT03605225

SponsorUniversitair Ziekenhuis Brussel

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-07-17

View on ClinicalTrials.gov More Neuromuscular Blockade trials