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

Postoperative Complications Clinical Trial

— ETCETERA  

Official title:

Original Title: Does ElecTromyography Improve preCision and Reliability of nEuromuscular moniToring in paEdiatRic pAtients - A Monocentric Randomized Prospective Agreement Study - ETCETERA

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06062290
• Other study ID #: ETCETERA
• Status: Recruiting
• Start date: September 20, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2023
• Source: University Hospital Ulm
• Contact: Sebastian Schmid, MD PD
• Phone: (+49) 731 500 60000
• Email: s.schmid[@]uni-ulm.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The ETCETERA trial is a randomized clinical agreement study which will prospectively enrol sixty-four children below five years of age scheduled for elective, non-cardiac surgery requiring general anaesthesia and neuromuscular blockade for optimisation of surgical conditions.

The children's neuromuscular function is measured on one hand with EMG and on the other hand with KMG in a randomised fashion. Additionally, randomisation will be stratified upon age groups: 1) neonates: birth to <28 days, 2) infants 28 days to ≤3 months, 3) toddlers: >3 months to ≤2 years, 4) children >2 years to <5 years.

Based on the high failure rate of currently available neuromuscular monitoring devices in infants and neonates, in this randomised agreement study we will primarily compare precision and reliability of EMG and KMG-measured Train-of-Four (TOF) values during spontaneous recovery from a rocuronium-induced neuromuscular blockade in neonates, infants, toddlers, and children <5 years using the age-appropriate paediatric sensors.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Hour to 5 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Delayed Emergence from Anesthesia
• Neuromuscular Blockade, Residual
• Postoperative Complications

Intervention

Device:
• Electromyography (EMG)
Measurement of the compound muscle action potential for the assessment of neuromuscular function
• Kinemyography (KMG)
Measurement of the muscle velocity for the assessment of neuromuscular function

Locations

Country	Name	City	State
Germany	University Hospital Ulm	Ulm	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Ulm

Country where clinical trial is conducted

Germany, 

References & 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Tactile TOF-count measurement	Tactile measurement of TOF response (EMG and KMG)	intraoperatively
Other	Postoperative pulmonary events	Including upper airway obstruction, hypoxemia, respiratory distress, aspiration, reintubation (Murphy et al.)	on the day of surgery in the recovery room
Other	Skin lesions, redness and pressure points on the forearms	Clinical safety outcome	on the day of surgery in the recovery room and at hospital discharge or on postoperative day 7, whichever occurs earlier
Other	Pain associated with the EMG and KMG measurement	Assessment through child discomfort and pain scale (KUSS) (Bittner et al.)	on the day of surgery in the recovery room and at hospital discharge or on postoperative day 7, whichever occurs earlier
Primary	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	Agreement of TOF values during spontaneous recovery of neuromuscular function	Agreement of TOF during spontaneous recovery of neuromuscular function, agreement of TOF at baseline and agreement of the final TOF at >0.9 and 1.0 will be verified.; 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