Clinical trial NCT03052894: Validation of a Muscle Relaxation Monitor
Official title: Validation of a Device to Monitor Muscle Relaxation During Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Neuromuscular Blockade
Keywords: anesthesiology
neuromuscular blockade
monitoring device
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Society for Technology in Anesthesia
name: University of Miami
First posted: 2017-02-14
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.

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.

Eligibility criteria: 1. Age \>18
2. Surgery is elective
3. Subject has been NPO for fluids for \>2 hours and for solids \>8 hours
4. General anesthesia with tracheal intubation is required
5. Mask ventilation is expected to be without difficulty
6. Subject voluntarily consents in writing to the protocol
7. ASA Physical Status 1-III (healthy individuals, those with mild comorbid conditions, or those with more serious co-morbid conditions that are well controlled)

Exclusion Criteria:

1. Lack of ability to provide written, informed consent
2. Airway examination indicates a likelihood of difficult mask ventilation
3. 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
4. Age ≤18 years
5. Pregnant women
6. Presence of carpal tunnel syndrome
7. Prisoners
8. General anesthesia not being provided
9. Tracheal intubation will not be performed
10. Anticipated length of surgery \<60 minutes
11. Emergent or urgent surgery
12. Disease that might alter the normal neuromuscular response to electrical stimulation (e.g., muscular dystrophies, myasthenia gravis, quadriplegia).
13. ASA Physical Status IV or V (individuals with major comorbid conditions that are a constant source of risk to health)

Primary outcomes:
measure: Accuracy of Hydraulic Twitch Monitoring Device in Measuring Neuromuscular Blockade as Compared to EMG Monitoring Device, Assessed using Repeated Measures Bland-Altman Analysis
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Department of Anesthesiology at University of Miami Hospital
state: Florida
Study officials:
affiliation: University of Miami
name: Richard Epstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.