Acute Compartment SyndromeNCT01283451
Ability of Near Infrared Spectroscopy to Isolate Compartments of the Extremity
An observational study of Acute Compartment Syndrome, run by J&M Shuler at 1 site in United States.
Trial summary
Near infrared spectroscopy (NIRS) provides a non-invasive means of continuously monitoring tissue oxygenation, which may be useful for diagnosis of acute compartment syndrome (ACS). Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Compartment Syndrome
- What is being tested?
- Muscle contraction
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Dec 2016
- Phase
- Observational
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study sample will consist of healthy volunteers recruited from the principle investigator's private practice.
Who may be able to join
- 18-75 years old
- no current extremity injuries
- willing to provide written informed consent
Who cannot join
- history of any anatomy-altering surgery to the extremity in question
- history of peripheral vascular disease
- history of pulmonary disease
Trial locations and contacts
1 site in 1 country.
About this study
Near infrared spectroscopy (NIRS) provides a non-invasive means of continuously monitoring tissue oxygenation, which may be useful for diagnosis of acute compartment syndrome (ACS). Placement of these sensor pads on the surface of the skin must be such that light penetrates the intended compartment without inadvertently obtaining measurements of an adjacent compartment. The objective of this study is to examine whether the NIRS measurements of each compartment truly represent the tissue perfusion of the intended compartment, as indicated by the predictable decrease in muscle oxygenation of a given compartment in response to muscle fatigue. The investigators hypothesize that the tissue oxygenation values of the stimulated compartment will significantly decrease following muscle stimulation, indicating that the intended muscle compartment was successfully isolated. Additionally, the investigators hypothesize that NIRS values of unstimulated muscle compartments will not change from baseline.
- Conditions
- Acute Compartment Syndrome
- Being tested
- Muscle contraction
- Keywords
- near-infrared spectroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle contractionBehavioural
Participants will perform a 30-60 second exercise designed to cause a temporary decrease in muscle oxygenation of a specific muscle group.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | NIRS values of all participants will be measured at baseline and following each 30-60 second exercise. Receives: Behavioral: Muscle contraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Near infrared spectroscopy
NIRS values will be measured before and after muscle fatigue
Measured: <30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2011 (estimated)
- Study startJan 2010
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Compartment SyndromeStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- J&M Shuler
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Shuler, MD, Principal investigator, Athens Orthopedic Clinic, PA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01283451
- Sponsor's protocol ID
- NIRS-01
- Status last verified
- Aug 2018
- First submitted
- 24 Jan 2011
- Last updated
- 15 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ability of Near Infrared Spectroscopy to Isolate Compartments of the Extremity
- ClinicalTrials.gov ID
- NCT01283451
- Acronym / sponsor ID
- NIRS-01
- Conditions
- Acute Compartment Syndrome
- Keywords
- near-infrared spectroscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- J&M ShulerIndustry (pharma, biotech, devices)
- Study start
- Jan 2010 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 26 Jan 2011 (estimated)
- 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.
Near infrared spectroscopy (NIRS) provides a non-invasive means of continuously monitoring tissue oxygenation, which may be useful for diagnosis of acute compartment syndrome (ACS). Placement of these sensor pads on the surface of the skin must be such that light penetrates the intended compartment without inadvertently obtaining measurements of an adjacent compartment. The objective of this study is to examine whether the NIRS measurements of each compartment truly represent the tissue perfusion of the intended compartment, as indicated by the predictable decrease in muscle oxygenation of a given compartment in response to muscle fatigue. The investigators hypothesize that the tissue oxygenation values of the stimulated compartment will significantly decrease following muscle stimulation, indicating that the intended muscle compartment was successfully isolated. Additionally, the investigators hypothesize that NIRS values of unstimulated muscle compartments will not change from baseline.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise | – | Behavioral: Muscle contractionNIRS values of all participants will be measured at baseline and following each 30-60 second exercise. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study sample will consist of healthy volunteers recruited from the principle investigator's private practice.
Key inclusion criteria (3 listed)
- 18-75 years old
- no current extremity injuries
- willing to provide written informed consent
Key exclusion criteria (3 listed)
- history of any anatomy-altering surgery to the extremity in question
- history of peripheral vascular disease
- history of pulmonary disease
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 |
|---|---|---|
| Muscle contractionParticipants will perform a 30-60 second exercise designed to cause a temporary decrease in muscle oxygenation of a specific muscle group. | Behavioural | Exercise |
Primary outcome
Near infrared spectroscopy
Time frame: <30 minutes
NIRS values will be measured before and after muscle fatigue
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 15 Aug 2018.
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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.
Michael Shuler, MD principal investigator
Athens Orthopedic Clinic, PA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Compartment Syndrome, run by J&M Shuler at 1 site in United States.
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 3 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 15 Aug 2018. 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 United States. 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?
Near infrared spectroscopy (time frame: <30 minutes). 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 15 Aug 2018.