Postoperative Residual Neuromuscular BlockadeNCT03891381
Electromyographic Monitoring and Postoperative Recovery
A study testing Tetragraph quantitative monitoring in people with Postoperative Residual Neuromuscular Blockade, run by Endeavor Health at 1 site in United States.
Trial summary
Residual neuromuscular blockade (weakness) is a common occurrence in the postanesthesia care unit when muscle relaxant drugs have been used in the operating room. The only method of reliably detecting residual neuromuscular blockade is through the use of quantitative neuromuscular monitors. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Residual Neuromuscular Blockade
- What is being tested?
- Tetragraph quantitative monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Mar 2019to 20 Oct 2020
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- presence of an underlying neuromuscular disease; use of drugs known to interfere with neuromuscular transmission (antiseizure medications, anticholinesterases, magnesium sulfate); renal insufficiency (serum creatinine > 1.8 mg/dL) or renal failure.
Trial locations and contacts
1 site in 1 country.
United States1 site
NorthShore University HealthSystem
Evanston, Illinois, 60201
About this study
Residual neuromuscular blockade (weakness) is a common occurrence in the postanesthesia care unit when muscle relaxant drugs have been used in the operating room. The only method of reliably detecting residual neuromuscular blockade is through the use of quantitative neuromuscular monitors. These devices measure and quantify the degree of muscle weakness and display the results on a screen. When using train-of-four (TOF) nerve stimulation, the ratio of the fourth muscle contraction (twitch) to the first twitch will be displayed; when this ratio is 90% (or 0.9) or greater, full recovery of muscle strength is present, and the endotracheal tube can be safely removed. At the present time, there is only one commercially available quantitative monitor produced in the United States -the TOF-Watch. The TOF-Watch is not used by many clinicians because it requires experience to obtain accurate results, is expensive, and is subject to interference by factors in the operating room. The aim of this investigation is to examine a new quantitative monitor (the TetraGraph, an electromyography (EMG) device) in the clinical setting. Patients will be randomized to receive either electromyography monitoring (EMG group-using the TetraGraph) or qualitative peripheral nerve stimulator monitoring (PNS group-the standard type of neuromuscular monitoring used at NorthShore University HealthSystem). The primary endpoint of the investigation is the incidence of postoperative residual blockade (defined as a TOF ratio < 0.9 with TOF-Watch, the current "gold standard quantitative monitor). Secondary endpoints include a variety of standard clinical recovery variables.
Read the detailed description
Although anesthesiologists recognize that residual neuromuscular block can adversely affect postoperative recovery, a high percentage of patients continue to arrive in the PACU with TOF ratios < 0.9. An important reason this problem occurs is that anesthesiologists rarely use quantitative neuromuscular monitoring in the operating room. In current anesthesia practices, clinicians typically use standard peripheral nerve stimulators (qualitative neuromuscular monitors) and / or clinical tests of muscle strength to detect residual muscle weakness at the end of surgical procedures. Qualitative nerve stimulators/monitors are routinely used in the operating rooms; TOF electrical stimuli are applied to a peripheral nerve, and the contractions of the innervated muscle observed. However, visual or tactile assessment of TOF stimulation using these monitors is only effective in detecting profound levels of muscle weakness (TOF ratios < 0.4) Therefore, qualitative nerve stimulators are unable to reliably detect clinically relevant neuromuscular block (TOF ratios of 0.5-0.9). Clinical assessment of patients for signs of muscle weakness (head-lift, hand squeeze) is also an insensitive method of detecting residual neuromuscular block, since many patients can perform these tests with TOF ratios as low as 0.5.
In order for clinicians to reliably exclude residual neuromuscular blockade, quantitative neuromuscular monitoring should be used. At the present time, only one stand-alone quantitative monitor has been produced for clinical use, the TOF-Watch (Blue Star Enterprises, Chanhassen, Minnesota-no longer manufactured). This technology (acceleromyography (AMG)) uses a piezoelectric crystal to sense the acceleration of muscle contractions, and converts this data into a displayed TOF ratio (0-100%). Although the use of the TOF-Watch has been demonstrated to reduce the risk of residual blockade, the routine application of this monitor by clinicians has been limited by a number of factors, related to complexity of use in the operating room.. There is an urgent need for an easy-to-use and accurate quantitative neuromuscular monitor in the clinical setting. Recently, a new device has been developed that uses electromyography (EMG) technology to assess recovery of muscle function in the clinical setting (the TetraGraph). This EMG device measures electrical activity (compound muscle action potentials) following nerve stimulation (usually at the thenar eminence after ulnar or median nerve stimulation). When TOF stimuli are provided, this data is then converted to a measurable TOF ratio (from 0-1.0 or 0-100%). In a study completed at NorthShore University HealthSystem, the investigators compared the applicability (ease of use, equipment need, etc.), repeatability (precision or internal consistency), and performance (agreement with established standard, bias) of this EMG technology to the TOF-Watch (the current clinical "gold standard" quantitative neuromuscular monitor). The subsequent analysis suggested that EMG monitoring accurately measures onset and recovery of neuromuscular function in the operating room.
The use of quantitative neuromuscular monitoring in the operating room should allow for more rational management of dosing and reversal of NMBAs. Furthermore, if incomplete neuromuscular recovery is detected at the end of a surgical procedure, tracheal extubation can be delayed until full recovery of muscle strength has occurred. Therefore, fewer patients should leave the operating room with muscle weakness, and the risks/complications of residual blockade in the PACU reduced. The aim of this clinical investigation is to determine whether EMG monitoring in the operating room reduces the incidence of postoperative residual blockade (measured at the time of tracheal extubation and on arrival to the PACU). During the PACU admission, patients will also be assessed for potential complications related to incomplete neuromuscular recovery (signs and symptoms of muscle weakness, episodes of hypoxemia and airway obstruction, prolonged PACU length of stay). Patients will be randomized to receive either electromyography monitoring (EMG group-TetraGraph) or qualitative peripheral nerve stimulator monitoring (PNS group) in the operating room. The primary endpoint is the incidence of postoperative residual block (defined as a TOF ratio < 0.9 with the TOF-Watch monitor). Secondary endpoints include a variety of clinical recovery variables listed below.
- Being tested
- Tetragraph quantitative monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tetragraph quantitative monitoringDevice
Neuromuscular monitoring will be guided by information provided by the Tetragraph
| Study group | Role | What they receive |
|---|---|---|
| Tetragraph | Experimental | Patients will be randomized to receive quantitative monitoring in the operating room. Neuromuscular management will be guided by information provided by the monitor Receives: Device: Tetragraph quantitative monitoring |
| Qualitative monitoring | Active comparator | The screen of the Tetragraph will be covered so that information is not provided to the clinician. The monitor will therefore function as a standard peripheral nerve monitor (clinicians will only observe the response to nerve stimulation) Receives: Device: Tetragraph quantitative monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative residual neuromuscular blockade
the percentage of patients admitted to the postanesthesia care unit with train-of-four ratios < 0.9 will be determined
Measured: 15 minutes
Secondary outcomes (3)
Incidence of hypoxemic events in the postanesthesia care unit
The number of patients with episodes of oxygen saturations < 95% will be determined
Measured: 60 minutes
Airway obstruction
the number of episodes of clinically-observed airway obstruction will be determined
Measured: 60 minutes
Symptoms of muscle weakness
The number of symptoms of muscle weakness measured 15 minutes after admission to the postanesthesia care unit will be determined
Measured: 15 minutes after admission to the postanesthesia care unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2019
- Study start26 Mar 2019
- Primary completion20 Oct 2020
- Study completion20 Oct 2020
Why it stopped: PI left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Residual 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized to a qualitative (peripheral nerve stimulator) or quantitative (Tetragraph) monitor
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endeavor Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Glenn S Murphy, MD, Principal investigator, Endeavor Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03891381
- Sponsor's protocol ID
- EH13-032
- Status last verified
- Feb 2020
- First submitted
- 25 Mar 2019
- Last updated
- 21 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electromyographic Monitoring and Postoperative Recovery
- ClinicalTrials.gov ID
- NCT03891381
- Acronym / sponsor ID
- EH13-032
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI left institution
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Endeavor HealthUniversity, hospital or other
- Study start
- 26 Mar 2019 (actual)
- Primary completion
- 20 Oct 2020 (actual)
- Study completion
- 20 Oct 2020 (actual)
- First posted
- 27 Mar 2019 (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.
Residual neuromuscular blockade (weakness) is a common occurrence in the postanesthesia care unit when muscle relaxant drugs have been used in the operating room. The only method of reliably detecting residual neuromuscular blockade is through the use of quantitative neuromuscular monitors. These devices measure and quantify the degree of muscle weakness and display the results on a screen. When using train-of-four (TOF) nerve stimulation, the ratio of the fourth muscle contraction (twitch) to the first twitch will be displayed; when this ratio is 90% (or 0.9) or greater, full recovery of muscle strength is present, and the endotracheal tube can be safely removed. At the present time, there is only one commercially available quantitative monitor produced in the United States -the TOF-Watch. The TOF-Watch is not used by many clinicians because it requires experience to obtain accurate results, is expensive, and is subject to interference by factors in the operating room. The aim of this investigation is to examine a new quantitative monitor (the TetraGraph, an electromyography (EMG) device) in the clinical setting. Patients will be randomized to receive either electromyography monitoring (EMG group-using the TetraGraph) or qualitative peripheral nerve stimulator monitoring (PNS group-the standard type of neuromuscular monitoring used at NorthShore University HealthSystem). The primary endpoint of the investigation is the incidence of postoperative residual blockade (defined as a TOF ratio < 0.9 with TOF-Watch, the current "gold standard quantitative monitor). Secondary endpoints include a variety of standard clinical recovery variables.
Detailed description
Although anesthesiologists recognize that residual neuromuscular block can adversely affect postoperative recovery, a high percentage of patients continue to arrive in the PACU with TOF ratios < 0.9. An important reason this problem occurs is that anesthesiologists rarely use quantitative neuromuscular monitoring in the operating room. In current anesthesia practices, clinicians typically use standard peripheral nerve stimulators (qualitative neuromuscular monitors) and / or clinical tests of muscle strength to detect residual muscle weakness at the end of surgical procedures. Qualitative nerve stimulators/monitors are routinely used in the operating rooms; TOF electrical stimuli are applied to a peripheral nerve, and the contractions of the innervated muscle observed. However, visual or tactile assessment of TOF stimulation using these monitors is only effective in detecting profound levels of muscle weakness (TOF ratios < 0.4) Therefore, qualitative nerve stimulators are unable to reliably detect clinically relevant neuromuscular block (TOF ratios of 0.5-0.9). Clinical assessment of patients for signs of muscle weakness (head-lift, hand squeeze) is also an insensitive method of detecting residual neuromuscular block, since many patients can perform these tests with TOF ratios as low as 0.5.
In order for clinicians to reliably exclude residual neuromuscular blockade, quantitative neuromuscular monitoring should be used. At the present time, only one stand-alone quantitative monitor has been produced for clinical use, the TOF-Watch (Blue Star Enterprises, Chanhassen, Minnesota-no longer manufactured). This technology (acceleromyography (AMG)) uses a piezoelectric crystal to sense the acceleration of muscle contractions, and converts this data into a displayed TOF ratio (0-100%). Although the use of the TOF-Watch has been demonstrated to reduce the risk of residual blockade, the routine application of this monitor by clinicians has been limited by a number of factors, related to complexity of use in the operating room.. There is an urgent need for an easy-to-use and accurate quantitative neuromuscular monitor in the clinical setting. Recently, a new device has been developed that uses electromyography (EMG) technology to assess recovery of muscle function in the clinical setting (the TetraGraph). This EMG device measures electrical activity (compound muscle action potentials) following nerve stimulation (usually at the thenar eminence after ulnar or median nerve stimulation). When TOF stimuli are provided, this data is then converted to a measurable TOF ratio (from 0-1.0 or 0-100%). In a study completed at NorthShore University HealthSystem, the investigators compared the applicability (ease of use, equipment need, etc.), repeatability (precision or internal consistency), and performance (agreement with established standard, bias) of this EMG technology to the TOF-Watch (the current clinical "gold standard" quantitative neuromuscular monitor). The subsequent analysis suggested that EMG monitoring accurately measures onset and recovery of neuromuscular function in the operating room.
The use of quantitative neuromuscular monitoring in the operating room should allow for more rational management of dosing and reversal of NMBAs. Furthermore, if incomplete neuromuscular recovery is detected at the end of a surgical procedure, tracheal extubation can be delayed until full recovery of muscle strength has occurred. Therefore, fewer patients should leave the operating room with muscle weakness, and the risks/complications of residual blockade in the PACU reduced. The aim of this clinical investigation is to determine whether EMG monitoring in the operating room reduces the incidence of postoperative residual blockade (measured at the time of tracheal extubation and on arrival to the PACU). During the PACU admission, patients will also be assessed for potential complications related to incomplete neuromuscular recovery (signs and symptoms of muscle weakness, episodes of hypoxemia and airway obstruction, prolonged PACU length of stay). Patients will be randomized to receive either electromyography monitoring (EMG group-TetraGraph) or qualitative peripheral nerve stimulator monitoring (PNS group) in the operating room. The primary endpoint is the incidence of postoperative residual block (defined as a TOF ratio < 0.9 with the TOF-Watch monitor). Secondary endpoints include a variety of clinical recovery variables listed below.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients will be randomized to a qualitative (peripheral nerve stimulator) or quantitative (Tetragraph) monitor
| Arm | Type | Receives |
|---|---|---|
| Tetragraph | Experimental | Device: Tetragraph quantitative monitoringPatients will be randomized to receive quantitative monitoring in the operating room. Neuromuscular management will be guided by information provided by the monitor |
| Qualitative monitoring | Active comparator | Device: Tetragraph quantitative monitoringThe screen of the Tetragraph will be covered so that information is not provided to the clinician. The monitor will therefore function as a standard peripheral nerve monitor (clinicians will only observe the response to nerve stimulation) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- presence of an underlying neuromuscular disease; use of drugs known to interfere with neuromuscular transmission (antiseizure medications, anticholinesterases, magnesium sulfate); renal insufficiency (serum creatinine > 1.8 mg/dL) or renal failure.
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 |
|---|---|---|
| Tetragraph quantitative monitoringNeuromuscular monitoring will be guided by information provided by the Tetragraph | Device | Qualitative monitoring, Tetragraph |
Primary outcome
Incidence of postoperative residual neuromuscular blockade
Time frame: 15 minutes
the percentage of patients admitted to the postanesthesia care unit with train-of-four ratios < 0.9 will be determined
3 secondary outcomes
Incidence of hypoxemic events in the postanesthesia care unit
Time frame: 60 minutes
Airway obstruction
Time frame: 60 minutes
Symptoms of muscle weakness
Time frame: 15 minutes after admission to the postanesthesia care unit
Results and safety
The study was stopped early (reason given: PI left institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2021.
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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.
Glenn S Murphy, MD principal investigator
Endeavor Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tetragraph quantitative monitoring in people with Postoperative Residual Neuromuscular Blockade, run by Endeavor Health 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 1 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 21 Dec 2021. 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: PI left institution). 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?
Incidence of postoperative residual neuromuscular blockade (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Dec 2021.