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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.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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
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

Other trials in United States

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 groups in NCT03891381
Study groupRoleWhat they receive
TetragraphExperimentalPatients 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 monitoringActive comparatorThe 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.

  1. 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)
  1. 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

  2. Airway obstruction

    the number of episodes of clinically-observed airway obstruction will be determined

    Measured: 60 minutes

  3. 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.

  1. First posted27 Mar 2019
  2. Study start26 Mar 2019
  3. Primary completion20 Oct 2020
  4. Study completion20 Oct 2020

Why it stopped: PI left institution

Resources

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)
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

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.

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