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

NCT03256955 | Completed

• 1 other identifier: TofCuff Study
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neuromuscular Blockade

Keywords

Validation study for a neuromuscular monitoring device

Outcome Measures

Primary Outcomes (1)

• Total recovery time of neuromuscular block

  The total recovery time, i.e. total duration of the neuromuscular block is defined as the time in minutes from start of injection of rocuronium until a normalized TOF ratio of 90% (Dur TOF 0.9). TOF = Train of Four

  60 to 120 minutes

Secondary Outcomes (5)

• Onset time

  1 to 4 minutes

• Duration TOF count 1

  20 - 30 minutes

• Duration TOF 25%

  30 - 40 minutes

• Duration TOF 50%

  30 - 50 minutes

• Duration TOF 75%

  30 - 60 minutes

Study Arms (1)

Tof Watch SX and Tof Cuff

OTHER

Patients undergoing surgery with intubation and receiving a single intubation dose of rocuronium (0.6 mg/kg) under propofol anesthesia will have monitoring of neuromuscular block with two monitors simultaneously.

Device: Tof cuff; Device: Tof Watch SX

Interventions

Tof cuff DEVICE

The Tof Cuff will be installed on one arm. After anesthesia induction the Tof Cuff will be calibrated and continuos monitoring of the neuromuscular block started until complete recovery of neuromuscular block.

Tof Watch SX and Tof Cuff

Tof Watch SX DEVICE

The Tof Watch SX will be installed on the opposite arm to the Tof Cuff. After anesthesia induction the Tof Watch SX will be calibrated and continuos monitoring of the neuromuscular block started until complete recovery of neuromuscular block.

Tof Watch SX and Tof Cuff

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients, age ≥18 to 65 years
• Patient with American Society of Anesthesiology \[ASA\] status I or II
• Patient able to read and understand the information sheet and to sign and date the consent form
• Patient scheduled for elective surgery lasting at least 60 minutes

You may not qualify if:

• Patient with a history of allergy or hypersensitivity to rocuronium
• Patient with pacemaker
• Patients with neuromuscular disease
• Patients with preoperative medications known to influence neuromuscular function (for instance aminoglycosides, phenytoin, lidocaine)
• Patients with electrolyte abnormalities (for instance, hypermagnesemia)
• Patients with a body mass index \<19 or \>30 kg m2
• Patient having participated in any clinical trial within 30 days, inclusive, of signing the informed consent form of the current trial
• Patients undergoing interventions that need a continuous deep NMB (for surgical reasons).

Sponsors & Collaborators

• Christoph Czarnetzki: lead

Study Sites (1)

University Hospitals of Geneva

Geneva, 1205, Switzerland

Location

Related Publications (3)

• Rodiera J, Serradell A, Alvarez-Gomez JA, Aliaga L. The cuff method: a pilot study of a new method of monitoring neuromuscular function. Acta Anaesthesiol Scand. 2005 Nov;49(10):1552-8. doi: 10.1111/j.1399-6576.2005.00777.x.

  PMID: 16223405 BACKGROUND

• Veiga Ruiz G, Garcia Cayuela J, Orozco Montes J, Parreno Caparros M, Garcia Rojo B, Aguayo Albasini JL. Monitoring intraoperative neuromuscular blockade and blood pressure with one device (TOF-Cuff): A comparative study with mechanomyography and invasive blood pressure. Rev Esp Anestesiol Reanim. 2017 Dec;64(10):560-567. doi: 10.1016/j.redar.2017.03.013. Epub 2017 Jun 27. English, Spanish.

  PMID: 28662770 BACKGROUND

• Sfeir Machado E, Keli-Barcelos G, Dupuis-Lozeron E, Tramer MR, Czarnetzki C. Assessment of spontaneous neuromuscular recovery: A comparison of the TOF-Cuff(R) with the TOF Watch SX(R). Acta Anaesthesiol Scand. 2020 Feb;64(2):173-179. doi: 10.1111/aas.13487. Epub 2019 Oct 28.

  PMID: 31593293 RESULT

Related Links

• Thesis for the validation of the tof cuff (in spanish)

Study Officials

• Christoph Czarnetzki, MD

  University Hospitals of Geneva

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Médecin adjoint

Study Record Dates

• First Submitted: August 16, 2017
• First Posted: August 22, 2017
• Study Start: June 23, 2017
• Primary Completion: May 14, 2018
• Study Completion: May 14, 2018
• Last Updated: October 31, 2019

Record last verified: 2019-10

Locations

CH (1)