Neuromuscular BlockadeNCT03605225
Development and Validation of an Android-based Application for Anaesthesia Neuromuscular Monitoring
A study testing mobile cellphone application test in people with Neuromuscular Blockade and Neuromuscular Monitoring, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Neuromuscular Blockade, Neuromuscular Monitoring
- What is being tested?
- mobile cellphone application test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteBelgium
- Study dates
- 7 Feb 2018to 16 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- mobile cellphone application test
- Keywords
- Android application, Anesthesia, intraoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mobile cellphone application testDevice
Placement of cellphone on the patient´s hand and recording accelerometric data during elicited muscular contractions.
| Study group | Role | What they receive |
|---|---|---|
| Cellphone application | Experimental | Train of Four (TOF) ratio displayed by the Cellphone Application Receives: Device: mobile cellphone application test |
| Draeger TOF Scan | Active comparator | Train of Four (TOF) ratio displayed by the Draeger TOF Scan Receives: Device: mobile cellphone application test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: before neuromuscular blocking drug administration, approximately 15 minutes after administration, and before extubation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2018
- Study start7 Feb 2018
- Primary completion17 Jul 2018
- Study completion16 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neuromuscular BlockadeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hugo Carvalho, MSc, MD, Principal investigator, Universitair Ziekenhuis BrusselJan D'Haese, MD, Study chair, Universitair Ziekenhuis BrusselJan Poelaert, PhD, MD, Study director, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03605225
- Sponsor's protocol ID
- APP NMM
- Status last verified
- Nov 2025
- First submitted
- 20 Jul 2018
- Last updated
- 18 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34152273
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of an Android-based Application for Anaesthesia Neuromuscular Monitoring
- ClinicalTrials.gov ID
- NCT03605225
- Acronym / sponsor ID
- APP NMM
- Conditions
- Neuromuscular Blockade, Neuromuscular Monitoring
- Keywords
- Android application, Anesthesia, intraoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 7 Feb 2018 (actual)
- Primary completion
- 17 Jul 2018 (actual)
- Study completion
- 16 Nov 2018 (actual)
- First posted
- 30 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cellphone application | Experimental | Device: mobile cellphone application testTrain of Four (TOF) ratio displayed by the Cellphone Application |
| Draeger TOF Scan | Active comparator | Device: mobile cellphone application testTrain of Four (TOF) ratio displayed by the Draeger TOF Scan |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mobile cellphone application testPlacement of cellphone on the patient´s hand and recording accelerometric data during elicited muscular contractions. | Device | Cellphone application, Draeger TOF Scan |
Primary outcome
Train of Four ratio
Time frame: before neuromuscular blocking drug administration, approximately 15 minutes after administration, and before extubation.
Ratio between de fourth and first accelerometric twitches of the thumb after elicited contraction via transcutaneous electrical stimulation of the ulnar nerve.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Derived from this study: PubMed 34152273Verdonck 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hugo Carvalho, MSc, MD principal investigator
Universitair Ziekenhuis Brussel
Jan D'Haese, MD study chair
Universitair Ziekenhuis Brussel
Jan Poelaert, PhD, MD study director
Universitair Ziekenhuis Brussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mobile cellphone application test in people with Neuromuscular Blockade and Neuromuscular Monitoring, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Train of Four ratio (time frame: before neuromuscular blocking drug administration, approximately 15 minutes after administration, and before extubation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03605225, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.