Validation of a Muscle Relaxation Monitor

Neuromuscular Blockade Clinical Trial

Official title:

Validation of a Device to Monitor Muscle Relaxation During Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03052894
• Other study ID #: 20161018
• Status: Terminated
• Phase: N/A
• Start date: December 31, 2018
• Est. completion date: December 1, 2019

Study information

• Verified date: December 2019
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: December 1, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Neuromuscular Blockade

Intervention

Device:
• Hydraulic Monitoring 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.
• Standard EMG Monitoring 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.

Locations

Country	Name	City	State
United States	Department of Anesthesiology at University of Miami Hospital	Miami	Florida

Sponsors (3)

Lead Sponsor	Collaborator
Richard H Epstein	Society for Technology in Anesthesia, University of Miami

Country where clinical trial is conducted

United States, 

References & Publications (8)

Ali HH, Utting JE, Gray TC. Quantitative assessment of residual antidepolarizing block. II. Br J Anaesth. 1971 May;43(5):478-85. — View 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 complicati — View 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. Review. Erratum in: Anesth Analg. 201 — View 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. — View 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. A — View 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. — View 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. Anesth — View Citation

Viby-Mogensen J, Jensen NH, Engbaek J, Ording H, Skovgaard LT, Chraemmer-Jørgensen B. Tactile and visual evaluation of the response to train-of-four nerve stimulation. Anesthesiology. 1985 Oct;63(4):440-3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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