Neuromuscular BlockadeNCT03052894
Validation of a Muscle Relaxation Monitor
A study testing Hydraulic Monitoring Device and Standard EMG Monitoring Device in people with Neuromuscular Blockade, run by Richard H Epstein at 1 site in United States.
Trial summary
The objective of this study is to determine the accuracy of a hydraulically coupled twitch monitor compared to the EMG twitch monitor in current use to measure the extent of neuromuscular blockade in patients undergoing general anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuromuscular Blockade
- What is being tested?
- Hydraulic Monitoring Device and Standard EMG Monitoring Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Dec 2018to 1 Dec 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Lack of ability to provide written, informed consent
- Airway examination indicates a likelihood of difficult mask ventilation
- Symptoms of active reflux at the time of induction, at risk of having food in their stomach at the time of induction, expected abnormal response to non-depolarizing neuromuscular blockers
- Age ≤18 years
- Pregnant women
- Presence of carpal tunnel syndrome
Show all 13Show fewer
- Prisoners
- General anesthesia not being provided
- Tracheal intubation will not be performed
- Anticipated length of surgery <60 minutes
- Emergent or urgent surgery
- Disease that might alter the normal neuromuscular response to electrical stimulation (e.g., muscular dystrophies, myasthenia gravis, quadriplegia).
- ASA Physical Status IV or V (individuals with major comorbid conditions that are a constant source of risk to health)
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Anesthesiology at University of Miami Hospital
Miami, Florida, 33136
About this study
Official title: Validation of a Device to Monitor Muscle Relaxation During Surgery
The objective of this study is to determine the accuracy of a hydraulically coupled twitch monitor compared to the EMG twitch monitor in current use to measure the extent of neuromuscular blockade in patients undergoing general anesthesia.
Read the detailed description
Neuromuscular blockade (paralysis) is necessary for many surgical procedures to provide optimal surgical conditions. The extent of paralysis typically assessed during routine clinical care by examining the muscle response of the thumb ("twitch") following delivery of a series of the "train-of-four".
Quantitative assessment of neuromuscular block can be assessed using electromyography (EMG) This technique measures action potential in the muscles of the thumb.
The proposed method is a simple technique that can constructed with equipment that is readily available in most operating rooms. If validated, it would provide a simple method to assess quantitatively the extent of neuromuscular blockade and recovery of muscle strength.
- Conditions
- Neuromuscular Blockade
- Being tested
- Hydraulic Monitoring Device, Standard EMG Monitoring Device
- Keywords
- anesthesiology, neuromuscular blockade, monitoring device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydraulic Monitoring DeviceDevice
The hydraulic monitoring device externally measures the pressure associated with thumb strength applied to the device to determine the depth of neuromuscular blockade during general anesthesia.
This will be compared to measurements using a current monitoring device in the same patient.
Standard EMG Monitoring DeviceDevice
Standard and in current usage, the electromyographic monitoring (EMG) device externally measures the action potential of the muscles of the thumb to determine the depth of neuromuscular blockade during general anesthesia.
This will be used as the clinical monitoring device and as a comparator.
| Study group | Role | What they receive |
|---|---|---|
| Hydraulic Monitoring Device | Experimental | Monitoring device to be compared to electromyographic (EMG) device in the same patient; measures depth of neuromuscular blockade during general anesthesia based on the pressure exerted by the muscles of the thumb. Receives: Device: Hydraulic Monitoring Device |
| Standard EMG Monitoring Device | Active comparator | Currently used standard monitoring device; measures depth of neuromuscular blockade during general anesthesia based on the action potential of the muscles of the thumb. Receives: Device: Standard EMG Monitoring Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Hydraulic Twitch Monitoring Device in Measuring Neuromuscular Blockade as Compared to EMG Monitoring Device, Assessed using Repeated Measures Bland-Altman Analysis
To determine the accuracy (bias and precision) of a the monitoring device as compared to the electromyographic (EMG) monitor in measuring the extent of neuromuscular blockade in subjects undergoing general anesthesia.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2017
- Study start31 Dec 2018
- Primary completion1 Dec 2019
- Study completion1 Dec 2019
Why it stopped: Data collection issues from the electronic health record.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)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
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Richard H Epstein
- Sponsor type
- University, hospital or other
- Collaborators
- Society for Technology in Anesthesia, University of Miami
- Responsible party
- Sponsor-investigator, Richard H Epstein, University of Miami
- Investigators
- Richard Epstein, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03052894
- Sponsor's protocol ID
- 20161018
- Status last verified
- Dec 2019
- First submitted
- 10 Feb 2017
- Last updated
- 17 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Brull SJ, Silverman DG. Visual assessment of train-of-four and double burst-induced fade at submaximal stimulating currents. Anesth Analg. 1991 Nov;73(5):627-32. doi: 10.1213/00000539-199111000-00020.
PubMed 1952146Viby-Mogensen J, Jensen NH, Engbaek J, Ording H, Skovgaard LT, Chraemmer-Jorgensen B. Tactile and visual evaluation of the response to train-of-four nerve stimulation. Anesthesiology. 1985 Oct;63(4):440-3. doi: 10.1097/00000542-198510000-00015. No abstract available.
PubMed 4037404Brull SJ, Murphy GS. Residual neuromuscular block: lessons unlearned. Part II: methods to reduce the risk of residual weakness. Anesth Analg. 2010 Jul;111(1):129-40. doi: 10.1213/ANE.0b013e3181da8312. Epub 2010 May 4.
PubMed 20442261Ali HH, Utting JE, Gray TC. Quantitative assessment of residual antidepolarizing block. II. Br J Anaesth. 1971 May;43(5):478-85. doi: 10.1093/bja/43.5.478. No abstract available.
PubMed 4254032Sundman E, Witt H, Olsson R, Ekberg O, Kuylenstierna R, Eriksson LI. The incidence and mechanisms of pharyngeal and upper esophageal dysfunction in partially paralyzed humans: pharyngeal videoradiography and simultaneous manometry after atracurium. Anesthesiology. 2000 Apr;92(4):977-84. doi: 10.1097/00000542-200004000-00014.
PubMed 10754616Kopman AF, Yee PS, Neuman GG. Relationship of the train-of-four fade ratio to clinical signs and symptoms of residual paralysis in awake volunteers. Anesthesiology. 1997 Apr;86(4):765-71. doi: 10.1097/00000542-199704000-00005.
PubMed 9105219Eriksson LI, Sundman E, Olsson R, Nilsson L, Witt H, Ekberg O, Kuylenstierna R. Functional assessment of the pharynx at rest and during swallowing in partially paralyzed humans: simultaneous videomanometry and mechanomyography of awake human volunteers. Anesthesiology. 1997 Nov;87(5):1035-43. doi: 10.1097/00000542-199711000-00005.
PubMed 9366453Berg H, Roed J, Viby-Mogensen J, Mortensen CR, Engbaek J, Skovgaard LT, Krintel JJ. Residual neuromuscular block is a risk factor for postoperative pulmonary complications. A prospective, randomised, and blinded study of postoperative pulmonary complications after atracurium, vecuronium and pancuronium. Acta Anaesthesiol Scand. 1997 Oct;41(9):1095-1103. doi: 10.1111/j.1399-6576.1997.tb04851.x.
PubMed 9366929
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Device to Monitor Muscle Relaxation During Surgery
- ClinicalTrials.gov ID
- NCT03052894
- Acronym / sponsor ID
- 20161018
- Conditions
- Neuromuscular Blockade
- Keywords
- anesthesiology, neuromuscular blockade, monitoring device
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Data collection issues from the electronic health record.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Richard H EpsteinUniversity, hospital or other
- Collaborators
- Society for Technology in Anesthesia, University of Miami
- Study start
- 31 Dec 2018 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 14 Feb 2017 (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 objective of this study is to determine the accuracy of a hydraulically coupled twitch monitor compared to the EMG twitch monitor in current use to measure the extent of neuromuscular blockade in patients undergoing general anesthesia.
Detailed description
Neuromuscular blockade (paralysis) is necessary for many surgical procedures to provide optimal surgical conditions. The extent of paralysis typically assessed during routine clinical care by examining the muscle response of the thumb ("twitch") following delivery of a series of the "train-of-four".
Quantitative assessment of neuromuscular block can be assessed using electromyography (EMG) This technique measures action potential in the muscles of the thumb.
The proposed method is a simple technique that can constructed with equipment that is readily available in most operating rooms. If validated, it would provide a simple method to assess quantitatively the extent of neuromuscular blockade and recovery of muscle strength.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydraulic Monitoring Device | Experimental | Device: Hydraulic Monitoring DeviceMonitoring device to be compared to electromyographic (EMG) device in the same patient; measures depth of neuromuscular blockade during general anesthesia based on the pressure exerted by the muscles of the thumb. |
| Standard EMG Monitoring Device | Active comparator | Device: Standard EMG Monitoring DeviceCurrently used standard monitoring device; measures depth of neuromuscular blockade during general anesthesia based on the action potential of the muscles of the thumb. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (13 listed)
- Lack of ability to provide written, informed consent
- Airway examination indicates a likelihood of difficult mask ventilation
- Symptoms of active reflux at the time of induction, at risk of having food in their stomach at the time of induction, expected abnormal response to non-depolarizing neuromuscular blockers
- Age ≤18 years
- Pregnant women
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 |
|---|---|---|
| Hydraulic Monitoring DeviceThe hydraulic monitoring device externally measures the pressure associated with thumb strength applied to the device to determine the depth of neuromuscular blockade during general anesthesia. This will be compared to measurements using a current monitoring device in the same patient. | Device | Hydraulic Monitoring Device |
| Standard EMG Monitoring DeviceStandard and in current usage, the electromyographic monitoring (EMG) device externally measures the action potential of the muscles of the thumb to determine the depth of neuromuscular blockade during general anesthesia. This will be used as the clinical monitoring device and as a comparator. | Device | Standard EMG Monitoring Device |
Primary outcome
Accuracy of Hydraulic Twitch Monitoring Device in Measuring Neuromuscular Blockade as Compared to EMG Monitoring Device, Assessed using Repeated Measures Bland-Altman Analysis
Time frame: 12 months
To determine the accuracy (bias and precision) of a the monitoring device as compared to the electromyographic (EMG) monitor in measuring the extent of neuromuscular blockade in subjects undergoing general anesthesia.
Results and safety
The study was stopped early (reason given: Data collection issues from the electronic health record.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2019.
- Results publication: PubMed 1952146Brull SJ, Silverman DG. Visual assessment of train-of-four and double burst-induced fade at submaximal stimulating currents. Anesth Analg. 1991 Nov;73(5):627-32. doi: 10.1213/00000539-199111000-00020.
- Results publication: PubMed 4037404Viby-Mogensen J, Jensen NH, Engbaek J, Ording H, Skovgaard LT, Chraemmer-Jorgensen B. Tactile and visual evaluation of the response to train-of-four nerve stimulation. Anesthesiology. 1985 Oct;63(4):440-3. doi: 10.1097/00000542-198510000-00015. No abstract available.
- Results publication: PubMed 20442261Brull SJ, Murphy GS. Residual neuromuscular block: lessons unlearned. Part II: methods to reduce the risk of residual weakness. Anesth Analg. 2010 Jul;111(1):129-40. doi: 10.1213/ANE.0b013e3181da8312. Epub 2010 May 4.
- Results publication: PubMed 4254032Ali HH, Utting JE, Gray TC. Quantitative assessment of residual antidepolarizing block. II. Br J Anaesth. 1971 May;43(5):478-85. doi: 10.1093/bja/43.5.478. No abstract available.
- Results publication: PubMed 10754616Sundman E, Witt H, Olsson R, Ekberg O, Kuylenstierna R, Eriksson LI. The incidence and mechanisms of pharyngeal and upper esophageal dysfunction in partially paralyzed humans: pharyngeal videoradiography and simultaneous manometry after atracurium. Anesthesiology. 2000 Apr;92(4):977-84. doi: 10.1097/00000542-200004000-00014.
- Results publication: PubMed 9105219Kopman AF, Yee PS, Neuman GG. Relationship of the train-of-four fade ratio to clinical signs and symptoms of residual paralysis in awake volunteers. Anesthesiology. 1997 Apr;86(4):765-71. doi: 10.1097/00000542-199704000-00005.
- Results publication: PubMed 9366453Eriksson LI, Sundman E, Olsson R, Nilsson L, Witt H, Ekberg O, Kuylenstierna R. Functional assessment of the pharynx at rest and during swallowing in partially paralyzed humans: simultaneous videomanometry and mechanomyography of awake human volunteers. Anesthesiology. 1997 Nov;87(5):1035-43. doi: 10.1097/00000542-199711000-00005.
- Results publication: PubMed 9366929Berg H, Roed J, Viby-Mogensen J, Mortensen CR, Engbaek J, Skovgaard LT, Krintel JJ. Residual neuromuscular block is a risk factor for postoperative pulmonary complications. A prospective, randomised, and blinded study of postoperative pulmonary complications after atracurium, vecuronium and pancuronium. Acta Anaesthesiol Scand. 1997 Oct;41(9):1095-1103. doi: 10.1111/j.1399-6576.1997.tb04851.x.
- Individual participant dataSharing planned: No
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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.
Richard Epstein, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydraulic Monitoring Device and Standard EMG Monitoring Device in people with Neuromuscular Blockade, run by Richard H Epstein at 1 site in United States.
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 0 inclusion and 13 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: stopped early, as of the sponsor's last update on 17 Dec 2019. 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 United States. 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 was stopped early (reason given: Data collection issues from the electronic health record.). Results are not available in the source record.
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?
Accuracy of Hydraulic Twitch Monitoring Device in Measuring Neuromuscular Blockade as Compared to EMG Monitoring Device, Assessed using Repeated Measures Bland-Altman Analysis (time frame: 12 months). 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 NCT03052894, which also lists 8 linked publications.
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 17 Dec 2019.