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Predicting Acute Compartment Syndrome (PACS) (PACS)

Primary Purpose

Acute Compartment Syndrome

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Continuous tissue perfusion monitoring by near-infrared spectroscopy (NIRS) and intramuscular pressure (IMP)

About this trial

This is an interventional diagnostic trial for Acute Compartment Syndrome focused on measuring fasciotomy, ACS

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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)
- 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

Exclusion Criteria:

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.

Sites / Locations

Denver Health and Hospital Authority
University of Maryland/R Adams Cowley Shock Trauma Medical Center
Hennepin County Medical Center / Regions Hospita
Carolinas Medical Center
Wake Forest University Baptist Medical Center
Vanderbilt Medical Center
San Antonio Military Medical Center

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01561261

First Posted

March 20, 2012

Last Updated

August 14, 2018

Sponsor

Major Extremity Trauma Research Consortium

1. Study Identification

Unique Protocol Identification Number

NCT01561261

Brief Title

Predicting Acute Compartment Syndrome (PACS)

Acronym

PACS

Official Title

Predicting Acute Compartment Syndrome (PACS) Using Optimized Clinical Assessment, Continuous Pressure Monitoring, and Continuous Tissue Oximetry

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Completed

Study Start Date

October 2012 (undefined)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Major Extremity Trauma Research Consortium

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Compartment Syndrome

Keywords

fasciotomy, ACS

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

194 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Other

Intervention Name(s)

Continuous tissue perfusion monitoring by near-infrared spectroscopy (NIRS) and intramuscular pressure (IMP)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Retrospective assessment of the likelihood of compartment syndrome

Description

Time Frame

6 months post index injury

Secondary Outcome Measure Information:

Title

Clinician agreement in retrospective assessments of the likelihood of ACS.

Description

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.

Time Frame

6 months post index injury

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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) 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 Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andrew Schmidt, MD

Organizational Affiliation

Hennepin County Medical Center / UMN

Official's Role

Principal Investigator

Facility Information:

Facility Name

Denver Health and Hospital Authority

City

Denver

State/Province

Colorado

ZIP/Postal Code

80203

Country

United States

Facility Name

University of Maryland/R Adams Cowley Shock Trauma Medical Center

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

212101

Country

United States

Facility Name

Hennepin County Medical Center / Regions Hospita

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55415

Country

United States

Facility Name

Carolinas Medical Center

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28204

Country

United States

Facility Name

Wake Forest University Baptist Medical Center

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157

Country

United States

Facility Name

Vanderbilt Medical Center

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232

Country

United States

Facility Name

San Antonio Military Medical Center

City

Fort Sam Houston

State/Province

Texas

ZIP/Postal Code

78234

Country

United States

12. IPD Sharing Statement

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Predicting Acute Compartment Syndrome (PACS)

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