Does Electromyography Improve Precision and Reliability of Neuromuscular Monitoring in Paediatric Patients

NCT06062290 | Active Not Recruiting

• 1 other identifier: ETCETERA
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Neuromuscular monitoring is used as a standard surveillance method of neuromuscular function to ensure full recovery at the end of anaesthesia. The currently available devices properly provide respective information in adults but not in children. Furthermore, response to neuromuscular blocking agents differs between adults and children due to age-related differences in body composition, physiological function, and acetylcholine receptor density. Recently, electromyographic (EMG) technologies to monitor neuromuscular function were increasingly developed including disposables for nerve stimulation and measurement of the compound muscle action potential in children. However, it is still unclear whether the precision and reliability of these devices is superior to the currently available neuromuscular monitoring for children based on kinemyography (KMG). The ETCETERA study will test the hypothesis that neither EMG nor KMG provides inferior train-of-four readings to the respective reference method in infants and children below five years.

Conditions

Neuromuscular Blockade, Residual; Postoperative Complications

Keywords

Electromyography; Neuromuscular Blockade; Postoperative Complications

Outcome Measures

Primary Outcomes (1)

• Precision of TOF (train of four) measurements

  The primary endpoint is the repeatability coefficient "r" defined as 1.96 times the standard deviation of the differences between two consecutive TOF ratio measurements on the same patient under identical conditions. The repeatability coefficient and its confidence intervals will be calculated using a linear mixed regression model for EMG and KMG measured TOF ratios independently at baseline and at complete neuromuscular recovery, i.e., at TOF ratio \> 0.9 and compared between techniques using F-tests with a non-inferiority approach.

  intraoperatively

Secondary Outcomes (1)

• Agreement of TOF values during spontaneous recovery of neuromuscular function

  intraoperatively

Other Outcomes (4)

• Tactile TOF-count measurement

  intraoperatively

• Postoperative pulmonary events

  on the day of surgery in the recovery room

• Skin lesions, redness and pressure points on the forearms

  on the day of surgery in the recovery room and at hospital discharge or on postoperative day 7, whichever occurs earlier

Study Arms (4)

neonates

birth to \<28 days

Device: Electromyography (EMG); Device: Kinemyography (KMG)

infants

28 days to ≤3 months

Device: Electromyography (EMG); Device: Kinemyography (KMG)

toddlers

\>3 months to ≤2 years

Device: Electromyography (EMG); Device: Kinemyography (KMG)

children

\>2 years to \<5 years

Device: Electromyography (EMG); Device: Kinemyography (KMG)

Interventions

Electromyography (EMG) DEVICE

Measurement of the compound muscle action potential for the assessment of neuromuscular function

children; infants; neonates; toddlers

Kinemyography (KMG) DEVICE

Measurement of the muscle velocity for the assessment of neuromuscular function

children; infants; neonates; toddlers

Eligibility Criteria

• Age: 1 Hour - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

The ETCETERA study will be performed in children \<5 years of age scheduled for elective, non-cardiac surgery requiring general anaesthesia and neuromuscular blockade.

You may qualify if:

• children and infants \< 5 years
• non-cardiac surgery requiring general anaesthesia and neuromuscular blockade
• signed informed written consent
• American Society of Anesthesiologists physical status \<4
• intraoperative positioning with access to both arms

You may not qualify if:

• allergy to neuromuscular blocking agents
• allergy to neuromuscular monitoring adhesive electrode
• neurologic disease
• surgical procedures outside the operating room
• children receiving neuromuscular blocking agents immediately before surgery

Sponsors & Collaborators

• University Hospital Ulm: lead

Study Sites (1)

University Hospital Ulm

Ulm, Baden-Wurttemberg, 89073, Germany

Location

Related Publications (2)

• Buttner W, Finke W, Hilleke M, Reckert S, Vsianska L, Brambrink A. [Development of an observational scale for assessment of postoperative pain in infants]. Anasthesiol Intensivmed Notfallmed Schmerzther. 1998 Jun;33(6):353-61. doi: 10.1055/s-2007-994263. German.

  PMID: 9689392 BACKGROUND

• Murphy GS, Szokol JW, Marymont JH, Greenberg SB, Avram MJ, Vender JS. Residual neuromuscular blockade and critical respiratory events in the postanesthesia care unit. Anesth Analg. 2008 Jul;107(1):130-7. doi: 10.1213/ane.0b013e31816d1268.

  PMID: 18635478 BACKGROUND

MeSH Terms

Conditions

Delayed Emergence from Anesthesia; Postoperative Complications

Interventions

Electromyography

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electrodiagnosis; Diagnostic Techniques and Procedures; Diagnosis; Myography

Study Officials

• Flora Scheffenbichler, MD

  Department of Anesthesiology and Intensive Care Medicine, University of Ulm, Ulm, Germany.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 15, 2023
• First Posted: October 2, 2023
• Study Start: September 20, 2023
• Primary Completion: May 10, 2024
• Study Completion: December 10, 2024
• Last Updated: September 24, 2024

Record last verified: 2024-09

Locations

DE (1)