NCT03256955

Validation of the TOF Cuff Monitor® Which Measures Neuromuscular Block on the Upper Arm

Completed NA Last updated 31 October 2019

What this trial tests

NA trial testing Tof cuff in Neuromuscular Blockade in 40 participants. Completed in 14 May 2018.

Timeline

23 June 2017

Primary endpoint
14 May 2018

14 May 2018

Quick facts

Lead sponsor	Christoph Czarnetzki
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	40
Start date	23 June 2017
Primary completion	14 May 2018
Estimated completion	14 May 2018
Sites	1 location across Switzerland

Drugs / interventions tested

• Tof cuff
• Tof Watch SX

Conditions studied

• Neuromuscular Blockade — all drugs for Neuromuscular Blockade →

Sponsor

Christoph Czarnetzki

Who can join

Adults 18 to 65, any sex, with Neuromuscular Blockade. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Neuromuscular blocking agents (NMBAs) are frequently used in anesthesia and quantitative neuromuscular monitoring is standard care. The TOF WATCH SX® monitor is considered as one of the reference monitoring devices in clinical research and clinical practice. With this monitor the ulnar nerve is stimulated at the wrist and the force of the movement of the thumb is measured with acceleromyography. This method requires freedom of movement of the patient's thumb. Unfortunately this is not always possible due to the constraints of patient positioning during the operation. The TOF Cuff® monitor is a modified non-invasive blood pressure cuff that incorporates stimulating electrodes in its inner surface and is based on the stimulation of the peripheral nerve in the arm (brachial plexus, ulnar and median nerves principally). The evoked neuromuscular activity is recorded through the changes in pressure generated in the inner part of the cuff by the muscular activity after the stimulus. Moreover, this device can be used for non-invasive reading of the blood pressure. This device has been validated with mechanomyography, but was never been compared with acceleromyography, which is the most common used neuromuscular monitoring method.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.