Neuromuscular Residual CurarizationNCT05231525
Comparison of the TOFScan and the WiTOF During Recovery of Neuromuscular Function
A study testing WiTOF and TOFscan in people with Neuromuscular Residual Curarization, run by Poitiers University Hospital at 1 site in France.
Trial summary
The purpose of this study is to compare two neuromuscular blockade monitors on recovery from an ATRACURIUM intra veinous injection for surgery. The TOFscan, a wired connected monitors and the WiTOF, a wireless connected monitor. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neuromuscular Residual Curarization
- What is being tested?
- WiTOF and TOFscan
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 9 Mar 2022to 20 Sep 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All programmed surgery with intraveinous injection of ATRACURIUM
- American society of anesthesiology patient score of I, II or III
- Patient being free of tutorship or curatorship
- Acceptance of the patient after clear and loyal information
Who cannot join
- Surgery without access simultaneously to the two arms
- Emergency surgery
- Rapid sequence induction
- Usage of an other curare than ATRACURIUM
- Contraindication on ATRACURIUM usage
- Patient with pace maker
Show all 10Show fewer
- Patient with Arné score > or = to 11
- Patient without social security coverage
- Pregnant of breastfeeding women
- Patient under social protection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Recovery Evaluation of Two Neuromuscular Blockade Monitoring Devices on Abductor Pollicis Muscle, the TOFScan and the Wireless WiTOF
The purpose of this study is to compare two neuromuscular blockade monitors on recovery from an ATRACURIUM intra veinous injection for surgery. The TOFscan, a wired connected monitors and the WiTOF, a wireless connected monitor.
Read the detailed description
The secondary objective will be to compare the performance of the two monitors on the abductor pollicis muscle with all the curarisation parameters (TOF, PTC, T4/T1R) and to assess interference occuring during the surgery which could limit the usage of a wireless monitor.
- Conditions
- Neuromuscular Residual Curarization
- Being tested
- WiTOF, TOFscan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WiTOFDevice
Data collection on the WiTOF monitor
TOFscanDevice
Data collection on the TOFscan monitor
| Study group | Role | What they receive |
|---|---|---|
| WiTOF | Experimental | Not described Receives: Device: WiTOF |
| TOFscan | Active comparator | Not described Receives: Device: TOFscan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the neuromuscular blockade recovery after intraveinous injection of atracurium with 2 differents monitors.
Comparison on the obtention delay for the T4/T1 ratio superior ou equal to 90% beetween the WiTOF and the TOFScan
Measured: During the whole period of the surgical operation maximum 8 hours
Secondary outcomes (2)
Evaluate the performance of the monitors for the follow up of neuromuscular recovery
Comparison of neuromuscular blockade parameters obtained with the WiTOF and the TOFScan (TOF, PTC, T4/1R)
Measured: During the whole period of the surgical operation maximum 8 hours
Number and duration of perturbation from the surgical environnement that could limit the usage of a wireless monitor
Assess what could perturbate the data collection on the wireless monitor
Measured: During the whole period of the surgical operation maximum 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2022
- Study start9 Mar 2022
- Primary completion20 Jun 2022
- Study completion20 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular Residual CurarizationStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthieu BOISSON, Principal investigator, CHU de Poitiers FRANCE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05231525
- Sponsor's protocol ID
- WiTOF
- Status last verified
- Nov 2022
- First submitted
- 5 Jan 2022
- Last updated
- 1 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recovery Evaluation of Two Neuromuscular Blockade Monitoring Devices on Abductor Pollicis Muscle, the TOFScan and the Wireless WiTOF
- ClinicalTrials.gov ID
- NCT05231525
- Acronym / sponsor ID
- WiTOF
- Conditions
- Neuromuscular Residual Curarization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 9 Mar 2022 (actual)
- Primary completion
- 20 Jun 2022 (actual)
- Study completion
- 20 Sep 2022 (actual)
- First posted
- 9 Feb 2022 (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.
The purpose of this study is to compare two neuromuscular blockade monitors on recovery from an ATRACURIUM intra veinous injection for surgery. The TOFscan, a wired connected monitors and the WiTOF, a wireless connected monitor.
Detailed description
The secondary objective will be to compare the performance of the two monitors on the abductor pollicis muscle with all the curarisation parameters (TOF, PTC, T4/T1R) and to assess interference occuring during the surgery which could limit the usage of a wireless monitor.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WiTOF | Experimental | Device: WiTOF |
| TOFscan | Active comparator | Device: TOFscan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All programmed surgery with intraveinous injection of ATRACURIUM
- American society of anesthesiology patient score of I, II or III
- Patient being free of tutorship or curatorship
- Acceptance of the patient after clear and loyal information
Key exclusion criteria (10 listed)
- Surgery without access simultaneously to the two arms
- Emergency surgery
- Rapid sequence induction
- Usage of an other curare than ATRACURIUM
- Contraindication on ATRACURIUM usage
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 |
|---|---|---|
| WiTOFData collection on the WiTOF monitor | Device | WiTOF |
| TOFscanData collection on the TOFscan monitor | Device | TOFscan |
Primary outcome
Evaluate the neuromuscular blockade recovery after intraveinous injection of atracurium with 2 differents monitors.
Time frame: During the whole period of the surgical operation maximum 8 hours
Comparison on the obtention delay for the T4/T1 ratio superior ou equal to 90% beetween the WiTOF and the TOFScan
2 secondary outcomes
Evaluate the performance of the monitors for the follow up of neuromuscular recovery
Time frame: During the whole period of the surgical operation maximum 8 hours
Number and duration of perturbation from the surgical environnement that could limit the usage of a wireless monitor
Time frame: During the whole period of the surgical operation maximum 8 hours
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 1 Dec 2022.
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Comparison of Adductor Pollicis and Abductor Digiti Minimi Muscles (Thumb Vs. Fifth Digit) As Sites for Neuromuscular Monitoring with Electromyography
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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.
Matthieu BOISSON principal investigator
CHU de Poitiers FRANCE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WiTOF and TOFscan in people with Neuromuscular Residual Curarization, run by Poitiers University Hospital at 1 site in France.
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 10 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 1 Dec 2022. 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 France. 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?
Evaluate the neuromuscular blockade recovery after intraveinous injection of atracurium with 2 differents monitors. (time frame: During the whole period of the surgical operation maximum 8 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Dec 2022.