Acute Compartment SyndromeNCT01123798
The Use of Near Infrared Spectroscopy in the Diagnosis of Acute Compartment Syndrome in Injured Soldiers
An observational study of Acute Compartment Syndrome, run by J&M Shuler at 1 site in Germany.
Trial summary
The purpose of this study is to define the reliability and accuracy of Near Infrared Spectroscopy (NIRS) in the detection of intra-compartmental tissue perfusion in injured and noninjured extremities over time. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Compartment Syndrome
- What is being tested?
- near-infrared spectroscopy
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2010to Jan 2011
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Active duty OIF/OEF military personnel who have been air evacuated from theater to Landstuhl Regional Medical Center (LRMC). Ambulatory, self-care volunteers from the LRMC outpatient spine center will be identified to serve as controls for Cohort 1.
Who may be able to join
- 18-65 years old
- male or female
- active duty servicemen who have been evacuated from OIF or OEF through LRMC
Who cannot join
- patients not willing to provide consent
- patients in whom application of NIRS monitoring is viewed as an impediment to casualty care
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to define the reliability and accuracy of Near Infrared Spectroscopy (NIRS) in the detection of intra-compartmental tissue perfusion in injured and noninjured extremities over time. The investigators hypothesize that this technology, combined with vital signs, intracompartmental pressures and clinical examinations, will be useful in diagnosing acute compartment syndrome (ACS), monitoring patients at risk for ACS, and evaluating the adequacy of fasciotomy in patients treated for ACS.
- Conditions
- Acute Compartment Syndrome
- Being tested
- near-infrared spectroscopy
- Keywords
- near infrared spectroscopy, lower extremity injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
near-infrared spectroscopyDevice
Non-invasive monitoring device applied on the surface of the skin that emits harmless red light to measure tissue perfusion.
| Study group | Role | What they receive |
|---|---|---|
| Stable controls | Uninjured soldiers to provide normative data for stable physiological status Receives: Device: near-infrared spectroscopy | |
| Critical controls | Critically injured soldiers with no lower extremity traumatic injuries (excepting skin abrasions and small/superficial fragmentation wounds) to provide normative data for the "shock" physiological status. Receives: Device: near-infrared spectroscopy | |
| Lower extremity trauma | Soldiers with severe traumatic lower extremity injuries in stable and shock physiologic status. This is the investigational cohort. Receives: Device: near-infrared spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
NIRS values in various physiologic states (stable control, critically injured control, lower extremity injury)
Measured: 24-48 hours from hospital admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2010 (estimated)
- Study startFeb 2010
- Primary completionJan 2011
- Study completionJan 2011
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- J&M Shuler
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense, Somanetics Corporation
- Investigators
- Brett Freedman, MD, Principal investigator, Landstuhl Regional Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01123798
- Sponsor's protocol ID
- DR080018-01
- Status last verified
- Jun 2011
- First submitted
- 17 Feb 2010
- Last updated
- 15 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Near Infrared Spectroscopy in the Diagnosis of Acute Compartment Syndrome in Injured Soldiers
- ClinicalTrials.gov ID
- NCT01123798
- Acronym / sponsor ID
- DR080018-01
- Conditions
- Acute Compartment Syndrome
- Keywords
- near infrared spectroscopy, lower extremity injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- J&M ShulerIndustry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense, Somanetics Corporation
- Study start
- Feb 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 14 May 2010 (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.
The purpose of this study is to define the reliability and accuracy of Near Infrared Spectroscopy (NIRS) in the detection of intra-compartmental tissue perfusion in injured and noninjured extremities over time. The investigators hypothesize that this technology, combined with vital signs, intracompartmental pressures and clinical examinations, will be useful in diagnosing acute compartment syndrome (ACS), monitoring patients at risk for ACS, and evaluating the adequacy of fasciotomy in patients treated for ACS.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Stable controls | – | Device: near-infrared spectroscopyUninjured soldiers to provide normative data for stable physiological status |
| Critical controls | – | Device: near-infrared spectroscopyCritically injured soldiers with no lower extremity traumatic injuries (excepting skin abrasions and small/superficial fragmentation wounds) to provide normative data for the "shock" physiological status. |
| Lower extremity trauma | – | Device: near-infrared spectroscopySoldiers with severe traumatic lower extremity injuries in stable and shock physiologic status. This is the investigational cohort. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Active duty OIF/OEF military personnel who have been air evacuated from theater to Landstuhl Regional Medical Center (LRMC). Ambulatory, self-care volunteers from the LRMC outpatient spine center will be identified to serve as controls for Cohort 1.
Key inclusion criteria (3 listed)
- 18-65 years old
- male or female
- active duty servicemen who have been evacuated from OIF or OEF through LRMC
Key exclusion criteria (2 listed)
- patients not willing to provide consent
- patients in whom application of NIRS monitoring is viewed as an impediment to casualty care
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 |
|---|---|---|
| near-infrared spectroscopyNon-invasive monitoring device applied on the surface of the skin that emits harmless red light to measure tissue perfusion. | Device | Critical controls, Lower extremity trauma, Stable controls |
Primary outcome
NIRS values in various physiologic states (stable control, critically injured control, lower extremity injury)
Time frame: 24-48 hours from hospital admission
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 Jun 2011.
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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.
Brett Freedman, MD principal investigator
Landstuhl Regional Medical Center
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 Germany.
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 2 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 Jun 2011. 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 Germany. 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?
NIRS values in various physiologic states (stable control, critically injured control, lower extremity injury) (time frame: 24-48 hours from hospital admission). 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 Jun 2011.