Validation of a Muscle Relaxation Monitor

NCT03052894 | Terminated FDA Device

• 1 other identifier: 20161018
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neuromuscular Blockade

Keywords

anesthesiology; neuromuscular blockade; monitoring device

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Study Arms (2)

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.

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.

Device: Standard EMG Monitoring Device

Interventions

Hydraulic Monitoring Device DEVICE

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.

Hydraulic Monitoring Device

Standard EMG Monitoring Device DEVICE

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.

Standard EMG Monitoring Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Richard H Epstein: lead
• Society for Technology in Anesthesia: collaborator
• University of Miami: collaborator

Study Sites (1)

Department of Anesthesiology at University of Miami Hospital

Miami, Florida, 33136, United States

Location

Related Publications (8)

• 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.

  PMID: 1952146 RESULT

• Viby-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.

  PMID: 4037404 RESULT

• Brull 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.

  PMID: 20442261 RESULT

• Ali 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.

  PMID: 4254032 RESULT

• Sundman 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.

  PMID: 10754616 RESULT

• Kopman 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.

  PMID: 9105219 RESULT

• Eriksson 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.

  PMID: 9366453 RESULT

• Berg 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.

  PMID: 9366929 RESULT

Study Officials

• Richard Epstein, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Clinical Anesthesiology

Study Record Dates

• First Submitted: February 10, 2017
• First Posted: February 14, 2017
• Study Start: December 31, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: December 17, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)