Acute Compartment SyndromePACSNCT01561261
Predicting Acute Compartment Syndrome (PACS)
A study testing Continuous tissue perfusion monitoring by near-infrared spectroscopy (NIRS) and intramuscular pressure (IMP) in people with Acute Compartment Syndrome, run by Major Extremity Trauma Research Consortium at 7 sites in United States.
Trial summary
The long-term objective is to develop a tool to aid in making a timely and accurate diagnosis of acute compartment syndrome (ACS). The immediate objective is to develop a model to accurately predict the likelihood of ACS based on data available to the clinician within the first 48 hours of injury (specific clinical… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Acute Compartment Syndrome
- What is being tested?
- Continuous tissue perfusion monitoring by near-infrared spectroscopy (NIRS) and intramuscular pressure (IMP)
- Type of treatment
- Injection or infusion
- How many people
- 194 participants
- Where
- 7 sitesUnited States
- Study dates
- Oct 2012to Mar 2017
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient between the ages of 18 and 60
- Weight of > 88 lb/40 kg
- Patient presents with one of the following injuries:
- Closed tibial shaft fracture with displacement, comminution, or segmental pattern
- Closed bicondylar tibial plateau fracture or medial tibial plateau-knee dislocation
- Open tibial shaft fracture (Gustilo Type I, II or IIIA)
Show all 16Show fewer
- Open bicondylar tibial plateau fracture or medial tibial plateau-knee dislocation (Gustilo Type I, II or IIIA)
- Severe soft tissue crush injury to lower leg
- Gun shot injury to leg
- Proximal fibula fracture
- Injury resulted from a high-energy mechanism (e.g. pedestrian struck; fall > 10 ft; MVA/MCA at speed > 30 mph; injury due to shotgun, rifle, or projectile)
- The injury occurs no more than 12 hours prior to initiation of monitoring
- If bilateral leg injuries are present, only the limb that is most severely injured in the judgment of the investigator will be studied
- At least one extremity must be uninjured to serve as a control for muscle oximetry
- Patients may have other injuries except as noted below under exclusion criteria
- Patient may have impending compartment syndrome at time of evaluation; however, the surgeon must be able to initiate monitoring and take at least one set of muscle pressures and obtain one set of tissue oxygenation measurements prior to performing fasciotomy
Who cannot join
- Soft tissue wounds that will interfere with monitoring (i.e. the insertion of indwelling pressure catheters and/or application of NIRS pads to the anterior and deep posterior compartments of the leg)
- Patients with known peripheral vascular disease
- Informed consent from the patient or from a legally authorized representative (LAR) is not obtained early enough to begin monitoring within 12 hours post-injury
- Non-ambulatory due to an associated complete spinal cord injury
- Non-ambulatory before the injury due to a pre-existing condition
- Patient speaks neither English nor Spanish
- Severe problems with maintaining follow-up (e.g. patients who are homeless at the time of injury or those how are intellectually challenged without adequate family support).
- Prior extensive traumatic injury requiring surgery to either lower extremity.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
University of Maryland/R Adams Cowley Shock Trauma Medical Center
Baltimore, Maryland, 212101
Carolinas Medical Center
Charlotte, North Carolina, 28204
Denver Health and Hospital Authority
Denver, Colorado, 80203
San Antonio Military Medical Center
Fort Sam Houston, Texas, 78234
Hennepin County Medical Center / Regions Hospita
Minneapolis, Minnesota, 55415
Vanderbilt Medical Center
Nashville, Tennessee, 37232
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157
About this study
Official title: Predicting Acute Compartment Syndrome (PACS) Using Optimized Clinical Assessment, Continuous Pressure Monitoring, and Continuous Tissue Oximetry
The long-term objective is to develop a tool to aid in making a timely and accurate diagnosis of acute compartment syndrome (ACS).
The immediate objective is to develop a model to accurately predict the likelihood of ACS based on data available to the clinician within the first 48 hours of injury (specific clinical findings supplemented by muscle oxygenation measured by near-infrared spectroscopy (NIRS), and continuous intramuscular pressure (IMP) and perfusion pressure (PP) monitoring).
Read more
Our primary outcome is the retrospective assessment of the likelihood of compartment syndrome made by a panel of clinicians using the following data:
- A physiologic "fingerprint" composed of continuous pressure versus time curve, continuous oximetry values, response of muscle to fasciotomy when performed, and serum biomarkers of muscle injury (CPK levels).
- Clinical and functional outcomes at 6 months post-injury including: sensory exam, muscle function, presence/absence of myoneural deficit, and patient reported function using the Short Musculoskeletal Function Assessment (SMFA).
Read the detailed description
Specific Aim 1: Prospectively enroll and follow for 6 months a sample of 200 patients. Patients will receive continuous tissue perfusion monitoring using NIRS in all 4 leg compartments and intramuscular pressure (IMP) via indwelling catheters placed in the anterior and deep posterior compartments. These measures will be blinded and not provided in real time to treating physicians. All clinical care, including diagnosis of ACS, will be according to current standard-of-care practiced at each institution.
Specific Aim 2: Convene expert panels of 5 orthopaedic surgeons experienced in the diagnosis and treatment of ACS to retrospectively assess the likelihood that each patient had ACS. This retrospective assessment will be based on a 'patient profile' summarizing data collected as part of this study.
Specific Aim 3: Determine the extent to which clinicians agree in retrospective assessments of the likelihood of ACS.
Hypothesis: On the basis of known clinical and functional outcome at 6 months and monitoring information, clinicians will agree on the likelihood of ACS in < 90% of cases.
Specific Aim 4: Model the panel's assessment of the likelihood of ACS as a function of data available to the clinician within the first 48 hours of injury using a training set of the data. This model can then be used to compute a point estimate of the risk of ACS (and associated 95% confidence interval) for any given patient.
Specific Aim 5: Assess, for patients in a test/validation data set, the performance of the model in predicting the panel's assessment of the likelihood of ACS.
Hypothesis: In < 95% of the cases, the panel's assessment of the likelihood of ACS will fall within the 95% interval of uncertainty predicted by the model.
- Conditions
- Acute Compartment Syndrome
- Being tested
- Continuous tissue perfusion monitoring by near-infrared spectroscopy (NIRS) and intramuscular pressure (IMP)
- Keywords
- fasciotomy, ACS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous tissue perfusion monitoring by near-infrared spectroscopy (NIRS) and intramuscular pressure (IMP)Other
Continuous monitoring of tissue perfusion using NIRS in all 4 leg muscle compartments and IMP via indwelling catheters in anterior and deep posterior compartments. These measures will not provided in real time to treating physicians. All clinical care, including the diagnosis of ACS, will be according to the current standard-of-care practiced at each institution, Clinicians may use the indwelling IMP monitor to obtain up to 2 discrete measures of IMP if they encounter a clinical situation in which they would normally measure IMP as an adjunct in their normal standard-of-care for the monitoring and diagnosis of compartment syndrome. Patients who undergo fasciotomy will also have NIRS and IMP values recorded from all 4 leg compartments immediately before and after fasciotomy.
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospective assessment of the likelihood of compartment syndrome
Retrospective assessment of the likelihood of compartment syndrome made by a panel of clinicians using the following data:
A physiologic "fingerprint" composed of continuous pressure vs. time curve, continuous oximetry values, response of muscle to fasciotomy when performed, and serum biomarkers of muscle injury (CPK levels).
Clinical and functional outcomes at 6 months post-injury including: sensory exam, muscle function, presence/absence of myoneural deficit, and patient reported function using the SMFA.
Measured: 6 months post index injury
Secondary outcomes (1)
Clinician agreement in retrospective assessments of the likelihood of ACS.
On the basis of known clinical and functional outcome at 6 months and monitoring information, clinicians will agree on the likelihood of ACS in <90% of cases.
Measured: 6 months post index injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2012 (estimated)
- Study startOct 2012
- Primary completionDec 2015
- Study completionMar 2017
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Major Extremity Trauma Research Consortium
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew Schmidt, MD, Principal investigator, Hennepin County Medical Center / UMN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01561261
- Sponsor's protocol ID
- 00004105
- Acronym
- PACS
- Status last verified
- Nov 2017
- First submitted
- 20 Mar 2012
- Last updated
- 15 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
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
- Predicting Acute Compartment Syndrome (PACS) Using Optimized Clinical Assessment, Continuous Pressure Monitoring, and Continuous Tissue Oximetry
- ClinicalTrials.gov ID
- NCT01561261
- Acronym / sponsor ID
- PACS / 00004105
- Conditions
- Acute Compartment Syndrome
- Keywords
- fasciotomy, ACS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Major Extremity Trauma Research ConsortiumUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 23 Mar 2012 (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 long-term objective is to develop a tool to aid in making a timely and accurate diagnosis of acute compartment syndrome (ACS).
The immediate objective is to develop a model to accurately predict the likelihood of ACS based on data available to the clinician within the first 48 hours of injury (specific clinical findings supplemented by muscle oxygenation measured by near-infrared spectroscopy (NIRS), and continuous intramuscular pressure (IMP) and perfusion pressure (PP) monitoring).
Our primary outcome is the retrospective assessment of the likelihood of compartment syndrome made by a panel of clinicians using the following data:
- A physiologic "fingerprint" composed of continuous pressure versus time curve, continuous oximetry values, response of muscle to fasciotomy when performed, and serum biomarkers of muscle injury (CPK levels).
- Clinical and functional outcomes at 6 months post-injury including: sensory exam, muscle function, presence/absence of myoneural deficit, and patient reported function using the Short Musculoskeletal Function Assessment (SMFA).
Detailed description
Specific Aim 1: Prospectively enroll and follow for 6 months a sample of 200 patients. Patients will receive continuous tissue perfusion monitoring using NIRS in all 4 leg compartments and intramuscular pressure (IMP) via indwelling catheters placed in the anterior and deep posterior compartments. These measures will be blinded and not provided in real time to treating physicians. All clinical care, including diagnosis of ACS, will be according to current standard-of-care practiced at each institution.
Specific Aim 2: Convene expert panels of 5 orthopaedic surgeons experienced in the diagnosis and treatment of ACS to retrospectively assess the likelihood that each patient had ACS. This retrospective assessment will be based on a 'patient profile' summarizing data collected as part of this study.
Specific Aim 3: Determine the extent to which clinicians agree in retrospective assessments of the likelihood of ACS.
Hypothesis: On the basis of known clinical and functional outcome at 6 months and monitoring information, clinicians will agree on the likelihood of ACS in < 90% of cases.
Specific Aim 4: Model the panel's assessment of the likelihood of ACS as a function of data available to the clinician within the first 48 hours of injury using a training set of the data. This model can then be used to compute a point estimate of the risk of ACS (and associated 95% confidence interval) for any given patient.
Specific Aim 5: Assess, for patients in a test/validation data set, the performance of the model in predicting the panel's assessment of the likelihood of ACS.
Hypothesis: In < 95% of the cases, the panel's assessment of the likelihood of ACS will fall within the 95% interval of uncertainty predicted by the model.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Patient between the ages of 18 and 60
- Weight of > 88 lb/40 kg
- Patient presents with one of the following injuries:
- Injury resulted from a high-energy mechanism (e.g. pedestrian struck; fall > 10 ft; MVA/MCA at speed > 30 mph; injury due to shotgun, rifle, or projectile)
- The injury occurs no more than 12 hours prior to initiation of monitoring
Key exclusion criteria (8 listed)
- Soft tissue wounds that will interfere with monitoring (i.e. the insertion of indwelling pressure catheters and/or application of NIRS pads to the anterior and deep posterior compartments of the leg)
- Patients with known peripheral vascular disease
- Informed consent from the patient or from a legally authorized representative (LAR) is not obtained early enough to begin monitoring within 12 hours post-injury
- Non-ambulatory due to an associated complete spinal cord injury
- Non-ambulatory before the injury due to a pre-existing condition
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 |
|---|---|---|
| Continuous tissue perfusion monitoring by near-infrared spectroscopy (NIRS) and intramuscular pressure (IMP)Continuous monitoring of tissue perfusion using NIRS in all 4 leg muscle compartments and IMP via indwelling catheters in anterior and deep posterior compartments. These measures will not provided in real time to treating physicians. All clinical care, including the diagnosis of ACS, will be according to the current standard-of-care practiced at each institution, Clinicians may use the indwelling IMP monitor to obtain up to 2 discrete measures of IMP if they encounter a clinical situation in which they would normally measure IMP as an adjunct in their normal standard-of-care for the monitoring and diagnosis of compartment syndrome. Patients who undergo fasciotomy will also have NIRS and IMP values recorded from all 4 leg compartments immediately before and after fasciotomy. | Other | – |
Primary outcome
Retrospective assessment of the likelihood of compartment syndrome
Time frame: 6 months post index injury
Retrospective assessment of the likelihood of compartment syndrome made by a panel of clinicians using the following data: A physiologic "fingerprint" composed of continuous pressure vs. time curve, continuous oximetry values, response of muscle to fasciotomy when performed, and serum biomarkers of muscle injury (CPK levels). Clinical and functional outcomes at 6 months post-injury including: sensory exam, muscle function, presence/absence of myoneural deficit, and patient reported function using the SMFA.
1 secondary outcome
Clinician agreement in retrospective assessments of the likelihood of ACS.
Time frame: 6 months post index injury
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.
Andrew Schmidt, MD principal investigator
Hennepin County Medical Center / UMN
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous tissue perfusion monitoring by near-infrared spectroscopy (NIRS) and intramuscular pressure (IMP) in people with Acute Compartment Syndrome, run by Major Extremity Trauma Research Consortium at 7 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 16 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: 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 7 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?
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?
Retrospective assessment of the likelihood of compartment syndrome (time frame: 6 months post index injury). 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.