Acute Compartment SyndromeNCT01171638
The Use of Near Infrared Spectroscopy in the Diagnosis of Acute Compartment Syndrome
An observational study of Acute Compartment Syndrome, run by J&M Shuler at 2 sites in United States.
Trial summary
This is a prospective observational study to determine the reliability and accuracy of Near Infrared Spectroscopy (NIRS) to detect oxygen flow in the extremities of injured and non-injured soldiers over time. This technology may be useful in the detection of acute compartment syndrome. Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Acute Compartment Syndrome
- What is being tested?
- Near infrared spectroscopy (NIRS)
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2011to Dec 2012
- 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 15 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Critically injured patients (Cohort 1) or patients with severe lower extremity injuries (Cohort 2), admitted to one of the participating sites, who meet the eligibility criteria described below.
Who may be able to join
- male or female subjects
- between the ages of 15 and 65 years old
- (Cohort 1 only) Admitted directly to the ICU of a participating study site
- (Cohort 2 only) Admitted to a participating study site with the following injury/mechanism combinations:
- Injuries:
- Segemental tibia shaft fracture
Show all 12Show fewer
- Comminuted tibia shaft fracture
- Schatzker Type III-VI tibial plateau fractures
- Mechanisms:
- Fall from a height of >= 8 feet
- Motor vehicle or motorcycle crash
- Pedestrian versus automobile
Who cannot join
- Patients, in whom application of NIRS monitoring is viewed as an impediment to care.
- Patients with known prior leg fractures (not related to current injury)
- History of peripheral vascular disease or lower extremity vascular surgery.
- Amputation
- Diagnoses with ACS prior to enrollment
- Spinal injuries resulting in complete loss of function
- Mangled lower extremity
- Bilateral upper extremity injuries
Trial locations and contacts
2 sites in 1 country.
Ashley Cole contact
United States2 sites
Atlanta Medical Center
Atlanta, Georgia
Bruce Ziran, MD
Grady Memorial Hospital
Atlanta, Georgia
William Reisman, MD
About this study
This is a prospective observational study to determine the reliability and accuracy of Near Infrared Spectroscopy (NIRS) to detect oxygen flow in the extremities of injured and non-injured soldiers over time. This technology may be useful in the detection of acute compartment syndrome. We hypothesize that:
- NIRS values will be well-correlated with intracompartmental pressure measurements
- NIRS values will be significantly different between non-injured and injured extremities, and injured extremities treated with fasciotomy for acute compartment syndrome.
- NIRS values of the upper extremity and feet will correlate to values from normal legs in critical control patients and patients with unilateral sever lower extremity injuries.
Read the detailed description
The purpose of this prospective observational cohort 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. Additionally, it will establish diagnostic perfusion value thresholds to be used in a subsequent interventional study confirming the efficacy of NIRS-based ACS monitoring. Through prospective measurements of NIRS values, vital signs, intracompartmental pressures and clinical examinations, guidelines and parameters will be established for the use of NIRS in diagnosing acute compartment syndrome (ACS), monitoring patients at risk for ACS and evaluating the adequacy of fasciotomy in patients treated for ACS.
Null hypotheses:
- NIRS values do not correlate with intracompartmental pressures, when they are obtained in the course of routine care of patients in the combat theater.
- There is no difference in the NIRS values between non-injured, injured extremities and injured extremities treated with fasciotomy for ACS
- NIRS values from the upper extremity and feet do not correlate to NIRS values from the normal legs in critical control patients and patients with unilateral severe lower extremity injury.
Specific Aims:
- Conduct observational, human-use, study to compile a normative reference database for NIRS-measured tissue perfusion in the uninjured upper extremity and the injured and non-injured legs of up to 120 injured subjects, from varying ethnicities (skin pigmentations) in varying degrees of hemodynamic status (stable, critically injured) to test the 3 hypotheses listed above. The study groups consist of one control group (critically ill without leg injuries) and one investigational group (critically injured with leg injuries):
- COHORT 1: 25 critically injured patients with NO severe traumatic lower extremity traumatic injuries to provide normative data for the "critically injured" physiological status ("Critical" CONTROLS)
- COHORT 2: 95 total (35 Cohort 2A; 35 Cohort 2B; 25 Cohort 2C) patients with "severe" traumatic lower extremity injuries presenting to a "participating" level 1 trauma center within 12 hours of their injury, to provide data on the acute post-injury phase. (INVESTIGATIONAL COHORT)
- COHORT 2A: Patients meeting COHORT 2 inclusion criteria, who have UNILATERAL "severe lower extremity injuries".
- COHORT 2B: Patients meeting COHORT 2 inclusion criteria, who have BILATERAL "severe lower extremity injuries".
- COHORT 2C (ACS GROUP): Patients meeting COHORT 2 inclusion criteria, who have been clinically diagnosed by the treating provider using that treating provider's standards of diagnosing ACS and the patient, in addition to being diagnosed with ACS, undergoes four-compartment leg fasciotomy. Patients in this cohort need data collection to start BEFORE fasciotomy and continue AFTER fasciotomy.
- Record provider comments regarding usability of the technology in its new embodiment and areas of needed design improvement. Apply this knowledge to perfect the industrial design and functionality of the final device.
- Establish evidenced-based clinical guidelines for the diagnosis and management of ACS in traumatically injured soldiers to be tested in a subsequent interventional clinical (IDE) study.
- Conditions
- Acute Compartment Syndrome
- Being tested
- Near infrared spectroscopy (NIRS)
- Keywords
- near infrared spectroscopy, compartment syndrome, fasciotomy, INVOS
- Medical subject headings
- Compartment Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near infrared spectroscopy (NIRS)Device
Also called Equanox Regional Oximeter, Nonin Medical, Plymouth, MN
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 |
|---|---|---|
| Critical Controls | Critically injured patients with NO "severe traumatic lower extremity" injuries to provide normative data for the "critically injured" physiological status upon arrival at study site Receives: Device: Near infrared spectroscopy (NIRS) | |
| Investigational cohort | Soldiers with "severe traumatic lower extremity" injuries in "stable" or "critical" physiological status presenting to a participating study site within 12 hours of their injury, to provide data on the acute post-injury phase. This cohort will be made up of:
* Patients meeting inclusion criteria for investigational cohort, who have UNILATERAL "severe lower extremity injuries"
* Patients meeting inclusion criteria for investigational cohort, who have BILATERAL "severe lower extremity injuries."
* Patients meeting inclusion criteria for investigational cohort, who have been clinically diagnosed by the treating provider using that treating providers standards for diagnosing ACS and the patient in addition to be diagnosed with ACS undergoes four-compartment leg fasciotomy. Receives: Device: Near infrared spectroscopy (NIRS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of acute compartment syndrome (ACS)
The "gold standard" criterion for ACS will be "clinical diagnosis". That is, all subjects undergoing fasciotomy for clinically diagnosed ACS (NOT PROPHYLACTIC fasciotomies) will be considered to have ACS. NIRS values will be compared to clinical diagnosis to determine accuracy and threshold values.
Measured: 24-48 hours at study site
Secondary outcomes (1)
Intracompartmental pressure (ICP)
ICP measurements will be taken at the doctor's discretion, as this is the only existing objective diagnostic tool for ACS. When available, ICP will be compared to NIRS values to assess the magnitude of agreement between the 2 tools.
Measured: 24-48 hours at study site
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2010 (estimated)
- Study startSep 2011
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- J&M Shuler
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense, Nonin Medical
- Investigators
- Brett Freedman, MD, Principal investigator, Landstuhl Regional Medical CenterWilliam Reisman, MD, Principal investigator, Emory UniversityBruce Ziran, MD, Principal investigator, Atlanta Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01171638
- Sponsor's protocol ID
- DR080018-02
- Status last verified
- Jun 2011
- First submitted
- 27 Jul 2010
- Last updated
- 15 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
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
- ClinicalTrials.gov ID
- NCT01171638
- Acronym / sponsor ID
- DR080018-02
- Conditions
- Acute Compartment Syndrome
- Keywords
- near infrared spectroscopy, compartment syndrome, fasciotomy, INVOS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- J&M ShulerIndustry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense, Nonin Medical
- Study start
- Sep 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 28 Jul 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.
This is a prospective observational study to determine the reliability and accuracy of Near Infrared Spectroscopy (NIRS) to detect oxygen flow in the extremities of injured and non-injured soldiers over time. This technology may be useful in the detection of acute compartment syndrome. We hypothesize that:
- NIRS values will be well-correlated with intracompartmental pressure measurements
- NIRS values will be significantly different between non-injured and injured extremities, and injured extremities treated with fasciotomy for acute compartment syndrome.
- NIRS values of the upper extremity and feet will correlate to values from normal legs in critical control patients and patients with unilateral sever lower extremity injuries.
Detailed description
The purpose of this prospective observational cohort 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. Additionally, it will establish diagnostic perfusion value thresholds to be used in a subsequent interventional study confirming the efficacy of NIRS-based ACS monitoring. Through prospective measurements of NIRS values, vital signs, intracompartmental pressures and clinical examinations, guidelines and parameters will be established for the use of NIRS in diagnosing acute compartment syndrome (ACS), monitoring patients at risk for ACS and evaluating the adequacy of fasciotomy in patients treated for ACS.
Null hypotheses:
- NIRS values do not correlate with intracompartmental pressures, when they are obtained in the course of routine care of patients in the combat theater.
- There is no difference in the NIRS values between non-injured, injured extremities and injured extremities treated with fasciotomy for ACS
- NIRS values from the upper extremity and feet do not correlate to NIRS values from the normal legs in critical control patients and patients with unilateral severe lower extremity injury.
Specific Aims:
- Conduct observational, human-use, study to compile a normative reference database for NIRS-measured tissue perfusion in the uninjured upper extremity and the injured and non-injured legs of up to 120 injured subjects, from varying ethnicities (skin pigmentations) in varying degrees of hemodynamic status (stable, critically injured) to test the 3 hypotheses listed above. The study groups consist of one control group (critically ill without leg injuries) and one investigational group (critically injured with leg injuries):
- COHORT 1: 25 critically injured patients with NO severe traumatic lower extremity traumatic injuries to provide normative data for the "critically injured" physiological status ("Critical" CONTROLS)
- COHORT 2: 95 total (35 Cohort 2A; 35 Cohort 2B; 25 Cohort 2C) patients with "severe" traumatic lower extremity injuries presenting to a "participating" level 1 trauma center within 12 hours of their injury, to provide data on the acute post-injury phase. (INVESTIGATIONAL COHORT)
- COHORT 2A: Patients meeting COHORT 2 inclusion criteria, who have UNILATERAL "severe lower extremity injuries".
- COHORT 2B: Patients meeting COHORT 2 inclusion criteria, who have BILATERAL "severe lower extremity injuries".
- COHORT 2C (ACS GROUP): Patients meeting COHORT 2 inclusion criteria, who have been clinically diagnosed by the treating provider using that treating provider's standards of diagnosing ACS and the patient, in addition to being diagnosed with ACS, undergoes four-compartment leg fasciotomy. Patients in this cohort need data collection to start BEFORE fasciotomy and continue AFTER fasciotomy.
- Record provider comments regarding usability of the technology in its new embodiment and areas of needed design improvement. Apply this knowledge to perfect the industrial design and functionality of the final device.
- Establish evidenced-based clinical guidelines for the diagnosis and management of ACS in traumatically injured soldiers to be tested in a subsequent interventional clinical (IDE) study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Critical Controls | – | Device: Near infrared spectroscopy (NIRS)Critically injured patients with NO "severe traumatic lower extremity" injuries to provide normative data for the "critically injured" physiological status upon arrival at study site |
| Investigational cohort | – | Device: Near infrared spectroscopy (NIRS)Soldiers with "severe traumatic lower extremity" injuries in "stable" or "critical" physiological status presenting to a participating study site within 12 hours of their injury, to provide data on the acute post-injury phase. This cohort will be made up of: * Patients meeting inclusion criteria for investigational cohort, who have UNILATERAL "severe lower extremity injuries" * Patients meeting inclusion criteria for investigational cohort, who have BILATERAL "severe lower extremity injuries." * Patients meeting inclusion criteria for investigational cohort, who have been clinically diagnosed by the treating provider using that treating providers standards for diagnosing ACS and the patient in addition to be diagnosed with ACS undergoes four-compartment leg fasciotomy. |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Critically injured patients (Cohort 1) or patients with severe lower extremity injuries (Cohort 2), admitted to one of the participating sites, who meet the eligibility criteria described below.
Key inclusion criteria (12 listed)
- male or female subjects
- between the ages of 15 and 65 years old
- (Cohort 1 only) Admitted directly to the ICU of a participating study site
- (Cohort 2 only) Admitted to a participating study site with the following injury/mechanism combinations:
- Segemental tibia shaft fracture
Key exclusion criteria (8 listed)
- Patients, in whom application of NIRS monitoring is viewed as an impediment to care.
- Patients with known prior leg fractures (not related to current injury)
- History of peripheral vascular disease or lower extremity vascular surgery.
- Amputation
- Diagnoses with ACS prior to enrollment
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 spectroscopy (NIRS)Also: Equanox Regional Oximeter, Nonin Medical, Plymouth, MNNon-invasive monitoring device applied on the surface of the skin that emits harmless red light to measure tissue perfusion. | Device | Critical Controls, Investigational cohort |
Primary outcome
Incidence of acute compartment syndrome (ACS)
Time frame: 24-48 hours at study site
The "gold standard" criterion for ACS will be "clinical diagnosis". That is, all subjects undergoing fasciotomy for clinically diagnosed ACS (NOT PROPHYLACTIC fasciotomies) will be considered to have ACS. NIRS values will be compared to clinical diagnosis to determine accuracy and threshold values.
1 secondary outcome
Intracompartmental pressure (ICP)
Time frame: 24-48 hours at study site
Results and safety
Results are not available in the source record.
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.
Ashley Cole contact
Brett Freedman, MD principal investigator
Landstuhl Regional Medical Center
William Reisman, MD principal investigator
Emory University
Bruce Ziran, MD principal investigator
Atlanta Medical Center
2 sites 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 2 sites 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 12 inclusion and 8 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: status not confirmed, 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 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ashley Cole (jandmshuler@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of acute compartment syndrome (ACS) (time frame: 24-48 hours at study site). 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.