Human VolunteersPhase 1NCT01452425
In Vivo Optical Spectroscopy Monitoring in a New Model of Muscular Compartment Syndrome
A Phase 1 study testing Tourniquet, INVOS assessment and EMG assessment in people with Human Volunteers, run by Université Catholique de Louvain at 1 site in Belgium.
Trial summary
Muscular compartment syndrome (MCS) is consecutive to an increase in intramuscular compartment pressures, and is a rare but serious postoperative complication. The INVOS (In Vivo Optical Spectroscopy) monitors tissular oxygenation continuously and non-invasively. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Human Volunteers
- What is being tested?
- Tourniquet, INVOS assessment and EMG assessment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2011to Dec 2011
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers
- >18yr
- Informed consent
- Male
Who cannot join
- Neuropathies
- Vascular pathology
- Actual pain
- Anti-platelet or anticoagulant therapy
- Ipsilateral history of fracture
Trial locations and contacts
1 site in 1 country.
About this study
Official title: In Vivo Optical Spectroscopy Monitoring in a New Model of Muscular Compartment Syndrome.
Muscular compartment syndrome (MCS) is consecutive to an increase in intramuscular compartment pressures, and is a rare but serious postoperative complication.
The INVOS (In Vivo Optical Spectroscopy) monitors tissular oxygenation continuously and non-invasively.
The objective is to develop a model mimicking the physiopathology of MCS to assess the interest of the INVOS in this case.
Read the detailed description
After inflation of a tourniquet (pressure equal to the mean arterial pressure, we will obtain a model of slight venous congestion and arterial hypoperfusion. A comparison will be made between INVOS monitoring, sensory deficits, pain, electromyography and invasive pressure.
- Conditions
- Human Volunteers
- Being tested
- Tourniquet, INVOS assessment, EMG assessment
- Keywords
- Human volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TourniquetDevice
Inflation of a tourniquet (pressure equal to the mean arterial pressure) obtaining a model of slight venous congestion and arterial hypoperfusion
INVOS assessmentDevice
Near Infraread spectroscopy, non invasive
EMG assessmentDevice
Electromyography, non invasive
| Study group | Role | What they receive |
|---|---|---|
| Tourniquet | Experimental | Inflation of a tourniquet Receives: Device: Tourniquet; Device: INVOS assessment; Device: EMG assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison Between INVOS Monitoring and Electromyography
A comparison will be made between the INVOS monitoring and non invasive (transcutaneous) EMG monitoring (AP Block), to determine the accuracy of the INVOS monitoring to predict AP block.
Measures were:
[mean (SD)] INVOS (in %) value at baseline and at the time of the block
Measured: 45 minutes
Intracompartmental Pressure (ICP)
[mean (SD)] ICP (in mmHg), value at baseline and at the time of the block
Measured: 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Human VolunteersStudies of the same condition, open and under way.
- More trials run by Université Catholique de LouvainThe 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 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Forget Patrice, Université Catholique de Louvain
- Investigators
- Patrice Forget, M.D., Principal investigator, UCL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01452425
- Sponsor's protocol ID
- B40320107753
- Status last verified
- Dec 2014
- First submitted
- 11 Oct 2011
- Last updated
- 22 Dec 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Optical Spectroscopy Monitoring in a New Model of Muscular Compartment Syndrome.
- ClinicalTrials.gov ID
- NCT01452425
- Acronym / sponsor ID
- B40320107753
- Conditions
- Human Volunteers
- Keywords
- Human volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 14 Oct 2011 (estimated)
- Results
- Posted 22 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Muscular compartment syndrome (MCS) is consecutive to an increase in intramuscular compartment pressures, and is a rare but serious postoperative complication.
The INVOS (In Vivo Optical Spectroscopy) monitors tissular oxygenation continuously and non-invasively.
The objective is to develop a model mimicking the physiopathology of MCS to assess the interest of the INVOS in this case.
Detailed description
After inflation of a tourniquet (pressure equal to the mean arterial pressure, we will obtain a model of slight venous congestion and arterial hypoperfusion. A comparison will be made between INVOS monitoring, sensory deficits, pain, electromyography and invasive pressure.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tourniquet | Experimental | Device: Tourniquet, Device: INVOS assessment, Device: EMG assessmentInflation of a tourniquet |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy volunteers
- >18yr
- Informed consent
- Male
Key exclusion criteria (5 listed)
- Neuropathies
- Vascular pathology
- Actual pain
- Anti-platelet or anticoagulant therapy
- Ipsilateral history of fracture
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 |
|---|---|---|
| TourniquetInflation of a tourniquet (pressure equal to the mean arterial pressure) obtaining a model of slight venous congestion and arterial hypoperfusion | Device | Tourniquet |
| INVOS assessmentNear Infraread spectroscopy, non invasive | Device | Tourniquet |
| EMG assessmentElectromyography, non invasive | Device | Tourniquet |
Primary outcome
Comparison Between INVOS Monitoring and Electromyography
Time frame: 45 minutes
A comparison will be made between the INVOS monitoring and non invasive (transcutaneous) EMG monitoring (AP Block), to determine the accuracy of the INVOS monitoring to predict AP block. Measures were: [mean (SD)] INVOS (in %) value at baseline and at the time of the block
Intracompartmental Pressure (ICP)
Time frame: 45 minutes
[mean (SD)] ICP (in mmHg), value at baseline and at the time of the block
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Patrice Forget, M.D. principal investigator
UCL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tourniquet, INVOS assessment and EMG assessment in people with Human Volunteers, run by Université Catholique de Louvain at 1 site in Belgium.
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 5 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 22 Dec 2014. 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 Belgium. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Comparison Between INVOS Monitoring and Electromyography (time frame: 45 minutes). The study lists 2 primary outcomes in all. 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 22 Dec 2014.