General AnesthesiaMONITOFNCT03847740
Safety and Feasibility of a New Neuromuscular Monitoring Device
A study testing Isometric Trumb Force handle in people with General Anesthesia, run by Poitiers University Hospital at 1 site in France.
Trial summary
The aim of the study is to compare, during general anesthesia using neuromuscular blocking agent, the feasibility of a new mechanographic device (ITF handle and Visual ITF software) with a standard acceleromyographic device (TOF Watch SX) and also to assess its safety during the first 24 hours after surgery. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- General Anesthesia
- What is being tested?
- Isometric Trumb Force handle
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 22 Feb 2019to 22 Aug 2019
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients,
- ASA class 1 to 3,
- Scheduled for elective surgery requiring general anesthesia and muscle paralysis
Who cannot join
- Age inferior to 18 years,
- ASA class 4,
- Emergency surgery,
- Prone position on the operating table
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to compare, during general anesthesia using neuromuscular blocking agent, the feasibility of a new mechanographic device (ITF handle and Visual ITF software) with a standard acceleromyographic device (TOF Watch SX) and also to assess its safety during the first 24 hours after surgery.
The two devices will be studied simultaneously in each patient.
- Conditions
- General Anesthesia
- Being tested
- Isometric Trumb Force handle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isometric Trumb Force handleDevice
Compare the pattern of neuromuscular blocking drug between two devices applied on the same patient during general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Right Isometric Thumb Force (ITF) handle | Experimental | Not described Receives: Device: Isometric Trumb Force handle |
| Left Isometric Thumb Force (ITF) handle | Experimental | Not described Receives: Device: Isometric Trumb Force handle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delay of block installation between the injection and the disappearance of all the muscular contractions to stimulation by train of four
We compare the response to curare with one side a conventional TOF Watch SX monitor and other side Handle Isometric Thumb Force.
Measured: Usefulness of non depolarizing muscle relaxant-induced muscle paralysis is limited at the surgery period and should be avoided once the surgery is completed. Therefore, all measurements are done during this time.
Secondary outcomes (5)
Clinical examination
Appearance of the wrist skin (for example: redness, irritations or marks)
Measured: the first 24 postoperative hours
Clinical examination
Wrist pain
Measured: the first 24 postoperative hours
Characteristics of maintenance curarization
Value of the post-tetanus count at the time of administration of an extra bolus of rocuronium and the number of muscle contractions in response to a four-train stimulation
Measured: Usefulness of non depolarizing muscle relaxant-induced muscle paralysis is limited at the surgery period and should be avoided once the surgery is completed. Therefore, all measurements are done during this time.
Characteristics of decurarization during spontaneous recovery phase
Delay of the gear ratio from train of four to 25; 75 and 90%.
Measured: Usefulness of non depolarizing muscle relaxant-induced muscle paralysis is limited at the surgery period and should be avoided once the surgery is completed. Therefore, all measurements are done during this time.
When the TOF ratio will be greater than 0.9 on the TOF Watch side, the degree of residual paralysis will be assessed on the ITF side using 100 Hz tetanus stimulation repeated 5 times at 2 minutes interval
The response of theses tetanus stimulations will be compared with the one observed before myorelaxant administration but after induction of anesthesia
Measured: Usefulness of non depolarizing muscle relaxant-induced muscle paralysis is limited at the surgery period and should be avoided once the surgery is completed. Therefore, all measurements are done during this time.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2019
- Study start22 Feb 2019
- Primary completion22 Aug 2019
- Study completion22 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General AnesthesiaStudies 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03847740
- Sponsor's protocol ID
- MONITOF
- Acronym
- MONITOF
- Status last verified
- Oct 2019
- First submitted
- 21 Jan 2019
- Last updated
- 31 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
- Safety and Feasibility of a New Neuromuscular Monitoring Device
- ClinicalTrials.gov ID
- NCT03847740
- Acronym / sponsor ID
- MONITOF / MONITOF
- Conditions
- General Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 22 Feb 2019 (actual)
- Primary completion
- 22 Aug 2019 (actual)
- Study completion
- 22 Aug 2019 (actual)
- First posted
- 20 Feb 2019 (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 aim of the study is to compare, during general anesthesia using neuromuscular blocking agent, the feasibility of a new mechanographic device (ITF handle and Visual ITF software) with a standard acceleromyographic device (TOF Watch SX) and also to assess its safety during the first 24 hours after surgery.
The two devices will be studied simultaneously in each patient.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Right Isometric Thumb Force (ITF) handle | Experimental | Device: Isometric Trumb Force handle |
| Left Isometric Thumb Force (ITF) handle | Experimental | Device: Isometric Trumb Force handle |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients,
- ASA class 1 to 3,
- Scheduled for elective surgery requiring general anesthesia and muscle paralysis
Key exclusion criteria (4 listed)
- Age inferior to 18 years,
- ASA class 4,
- Emergency surgery,
- Prone position on the operating table
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 |
|---|---|---|
| Isometric Trumb Force handleCompare the pattern of neuromuscular blocking drug between two devices applied on the same patient during general anesthesia. | Device | Left Isometric Thumb Force (ITF) handle, Right Isometric Thumb Force (ITF) handle |
Primary outcome
Delay of block installation between the injection and the disappearance of all the muscular contractions to stimulation by train of four
Time frame: Usefulness of non depolarizing muscle relaxant-induced muscle paralysis is limited at the surgery period and should be avoided once the surgery is completed. Therefore, all measurements are done during this time.
We compare the response to curare with one side a conventional TOF Watch SX monitor and other side Handle Isometric Thumb Force.
5 secondary outcomes
Clinical examination
Time frame: the first 24 postoperative hours
Clinical examination
Time frame: the first 24 postoperative hours
Characteristics of maintenance curarization
Time frame: Usefulness of non depolarizing muscle relaxant-induced muscle paralysis is limited at the surgery period and should be avoided once the surgery is completed. Therefore, all measurements are done during this time.
Characteristics of decurarization during spontaneous recovery phase
Time frame: Usefulness of non depolarizing muscle relaxant-induced muscle paralysis is limited at the surgery period and should be avoided once the surgery is completed. Therefore, all measurements are done during this time.
When the TOF ratio will be greater than 0.9 on the TOF Watch side, the degree of residual paralysis will be assessed on the ITF side using 100 Hz tetanus stimulation repeated 5 times at 2 minutes interval
Time frame: Usefulness of non depolarizing muscle relaxant-induced muscle paralysis is limited at the surgery period and should be avoided once the surgery is completed. Therefore, all measurements are done during this time.
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.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isometric Trumb Force handle in people with General Anesthesia, 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 3 inclusion and 4 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 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?
Delay of block installation between the injection and the disappearance of all the muscular contractions to stimulation by train of four (time frame: Usefulness of non depolarizing muscle relaxant-induced muscle paralysis is limited at the surgery period and should be avoided once the surgery is completed. Therefore, all measurements are done during this time.). 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 31 Oct 2019.