Neuromuscular BlockadeNCT03256955
Validation of the TOF Cuff Monitor® Which Measures Neuromuscular Block on the Upper Arm
A study testing Tof cuff and Tof Watch SX in people with Neuromuscular Blockade, run by Christoph Czarnetzki at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neuromuscular Blockade
- What is being tested?
- Tof cuff and Tof Watch SX
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- 23 Jun 2017to 14 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Comparison of the TOF Cuff Monitor® With the TOF Watch SX® Monitor:
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.
Read the detailed description
Neuromuscular blocking agents (NMBAs) are frequently used in anesthesia for tracheal intubation, artificial ventilation, and continued muscle relaxation during surgical interventions. It is of particular importance to measure the neuromuscular block for several reasons:
- To monitor the onset of neuromuscular block and to intubate when deep muscular relaxation is attained.
- To choose the best antagonist and its dosage dependent of the degree of neuromuscular block (for instance sugammadex for deep neuromuscular block or neostigmine for superficial block).
- To avoid antagonization of neuromuscular block in the case of complete recovery of neuromuscular function.
It is proven that monitoring of neuromuscular block reduces patient mortality. It avoids postoperative residual curarization, which is associated with complications such as hypoxemia, bronchoaspiration and pneumonia. Therefore the development and validation of new and efficacious neuromuscular monitoring devices is of great importance.
Neuromuscular monitoring is done by stimulating with an electric current a nerve and to measure the response of the corresponding muscle. In clinical practice acceleromyography is the most often used quantitative measurement method, because it is much easier to apply than other established quantitative neuromuscular monitoring methods such as mechanomyograpy and electromyography. Acceleromyography is based on the piezoelectric effect where mechanical forces at play on the surfaces of certain materials, such as crystals or ceramics, induce an electrical current. According to Newton's second law of motion, force equals mass times acceleration (F=m x a). At constant mass, the acceleration measured and the voltage thereby generated can be used to derive the force of the stimulated muscle. It is standard practice to stimulate the ulnar nerve at the wrist and to measure the movement of the adductor pollicis. In the research setting acceleromyography (TOF Watch SX® monitor) is an established and widely used method. 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
- Being tested
- Tof cuff, Tof Watch SX
- Keywords
- Validation study for a neuromuscular monitoring device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tof cuffDevice
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 SXDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Tof cuff; Device: Tof Watch SX |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 60 to 120 minutes
Secondary outcomes (5)
Onset time
time in seconds from start of injection of rocuronium until 95% depression of the first twitch (T1) of the TOF(Train of Four)
Measured: 1 to 4 minutes
Duration TOF count 1
Time (in minutes) from administration of rocuronium to emergence of the 1st twitch of the TOF (Dur TOFc1)
Measured: 20 - 30 minutes
Duration TOF 25%
Time (in minutes) from administration of rocuronium to emergence of a normalized TOF ratio of 25%
Measured: 30 - 40 minutes
Duration TOF 50%
Time (in minutes) from administration of rocuronium to emergence of a normalized TOF ratio of 50%
Measured: 30 - 50 minutes
Duration TOF 75%
Time (in minutes) from administration of rocuronium to emergence of a normalized TOF ratio of 75%
Measured: 30 - 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2017
- Study start23 Jun 2017
- Primary completion14 May 2018
- Study completion14 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Neuromuscular BlockadeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christoph Czarnetzki
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Christoph Czarnetzki, University Hospital, Geneva
- Investigators
- Christoph Czarnetzki, MD, Study chair, University Hospitals of Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03256955
- Sponsor's protocol ID
- TofCuff Study
- Status last verified
- Oct 2019
- First submitted
- 16 Aug 2017
- Last updated
- 31 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 16223405Veiga 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.
PubMed 28662770Sfeir 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.
PubMed 31593293
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of the TOF Cuff Monitor® With the TOF Watch SX® Monitor:
- ClinicalTrials.gov ID
- NCT03256955
- Acronym / sponsor ID
- TofCuff Study
- Conditions
- Neuromuscular Blockade
- Keywords
- Validation study for a neuromuscular monitoring device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Christoph CzarnetzkiUniversity, hospital or other
- Study start
- 23 Jun 2017 (actual)
- Primary completion
- 14 May 2018 (actual)
- Study completion
- 14 May 2018 (actual)
- First posted
- 22 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Neuromuscular blocking agents (NMBAs) are frequently used in anesthesia for tracheal intubation, artificial ventilation, and continued muscle relaxation during surgical interventions. It is of particular importance to measure the neuromuscular block for several reasons:
- To monitor the onset of neuromuscular block and to intubate when deep muscular relaxation is attained.
- To choose the best antagonist and its dosage dependent of the degree of neuromuscular block (for instance sugammadex for deep neuromuscular block or neostigmine for superficial block).
- To avoid antagonization of neuromuscular block in the case of complete recovery of neuromuscular function.
It is proven that monitoring of neuromuscular block reduces patient mortality. It avoids postoperative residual curarization, which is associated with complications such as hypoxemia, bronchoaspiration and pneumonia. Therefore the development and validation of new and efficacious neuromuscular monitoring devices is of great importance.
Neuromuscular monitoring is done by stimulating with an electric current a nerve and to measure the response of the corresponding muscle. In clinical practice acceleromyography is the most often used quantitative measurement method, because it is much easier to apply than other established quantitative neuromuscular monitoring methods such as mechanomyograpy and electromyography. Acceleromyography is based on the piezoelectric effect where mechanical forces at play on the surfaces of certain materials, such as crystals or ceramics, induce an electrical current. According to Newton's second law of motion, force equals mass times acceleration (F=m x a). At constant mass, the acceleration measured and the voltage thereby generated can be used to derive the force of the stimulated muscle. It is standard practice to stimulate the ulnar nerve at the wrist and to measure the movement of the adductor pollicis. In the research setting acceleromyography (TOF Watch SX® monitor) is an established and widely used method. 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tof Watch SX and Tof Cuff | Other | Device: Tof cuff, Device: Tof Watch SXPatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tof cuffThe 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. | Device | Tof Watch SX and Tof Cuff |
| Tof Watch SXThe 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. | Device | Tof Watch SX and Tof Cuff |
Primary outcome
Total recovery time of neuromuscular block
Time frame: 60 to 120 minutes
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
5 secondary outcomes
Onset time
Time frame: 1 to 4 minutes
Duration TOF count 1
Time frame: 20 - 30 minutes
Duration TOF 25%
Time frame: 30 - 40 minutes
Duration TOF 50%
Time frame: 30 - 50 minutes
Duration TOF 75%
Time frame: 30 - 60 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2019.
- Background: PubMed 16223405Rodiera 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.
- Background: PubMed 28662770Veiga 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.
- Results publication: PubMed 31593293Sfeir 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoph Czarnetzki, MD study chair
University Hospitals of Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tof cuff and Tof Watch SX in people with Neuromuscular Blockade, run by Christoph Czarnetzki at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total recovery time of neuromuscular block (time frame: 60 to 120 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03256955, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2019.