Ignite Creation Date:
2024-05-06 @ 12:22 AM
Last Modification Date:
2024-10-26 @ 10:49 AM
Study NCT ID:
NCT01561261
Status:
COMPLETED
Last Update Posted:
2018-08-15
First Post:
2012-03-20
Brief Title:
Predicting Acute Compartment Syndrome PACS
Sponsor:
Major Extremity Trauma Research Consortium
Organization:
Major Extremity Trauma Research Consortium
Study Overview
Official Title:
Predicting Acute Compartment Syndrome PACS Using Optimized Clinical Assessment Continuous Pressure Monitoring and Continuous Tissue Oximetry
Status:
COMPLETED
Status Verified Date:
2017-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PACS
Brief 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 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 presenceabsence of myoneural deficit and patient reported function using the Short Musculoskeletal Function Assessment SMFA
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 presenceabsence 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 panels 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 testvalidation data set the performance of the model in predicting the panels assessment of the likelihood of ACS
Hypothesis In 95 of the cases the panels assessment of the likelihood of ACS will fall within the 95 interval of uncertainty predicted by the model
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 panels 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 testvalidation data set the performance of the model in predicting the panels assessment of the likelihood of ACS
Hypothesis In 95 of the cases the panels assessment of the likelihood of ACS will fall within the 95 interval of uncertainty predicted by the model
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None