Ignite Creation Date:
2024-05-06 @ 12:19 AM
Last Modification Date:
2024-10-26 @ 10:48 AM
Study NCT ID:
NCT01547013
Status:
UNKNOWN
Last Update Posted:
2021-03-26
First Post:
2012-03-01
Brief Title:
The Use of Near Infrared Spectroscopy in the Diagnosis of Acute Compartment Syndrome in Trauma Patients
Sponsor:
US Army Medical Research and Development Command
Organization:
US Army Medical Research and Development Command
Study Overview
Official Title:
Phase II The Use of Near Infrared Spectroscopy in the Diagnosis of Acute Compartment Syndrome in Trauma Patients
Status:
UNKNOWN
Status Verified Date:
2021-03
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
NIRS
Brief Summary:
This is a study intended to evaluate a new device that uses light to measure the amount of oxygen in the muscles of injured and non-injured legs and forearms in specific situations The name of this technology is NIRS near-infrared spectroscopy This is a prospective observational cohort study intended to gather data using NIRS among injured and noninjured extremities over time Additionally this data will help in establishing diagnostic perfusion value thresholds to be used in a subsequent interventional study confirming the efficacy of NIRS-based ACS monitoring
Detailed Description:
Swelling builds up in a severely injured leg for example a broken leg In up to 20 of very bad injuries the swelling can be so great that it acts to cut off blood supply to the leg strangulating it from the inside When this occurs it is called Acute Compartment Syndrome ACS This is a painful and bad situation which needs to be diagnosed and then surgically treated in an urgent fashion Currently the standard way most physicians diagnose ACS is by clinical examination By asking the patient questions moving and inspecting the patients leg and typically inserting a needle in the patients legs to measure the amount of pressure in each leg Physicians compile this information and make the final diagnosis This method of diagnosis can be painful and requires measurements sometimes invasive to be made at points in time ACS is a disease process that develops over time therefore someone may not have ACS at the time of examination but may develop it several hours later The treatment for ACS is called a fasciotomy This treatment involves making a large incision from the knee to the ankle on each side of the lower leg
The NIRS device has already been cleared by the FDA for detecting blood flow to the brain during anesthesia NIRS may also be helpful in diagnosing ACS Two of the primary advantages of this device are that it is noninvasive not painful and it collects data continuously so that if the disease develops it can be detected early and treated appropriately In order to prove this the device must first be tested by taking a series of measurements on people that are uninjured control groups those with serious leg injuries investigational groups and people in a critically injured state but without leg injuries critical controls
The goal of this study is to collect the information necessary to understand and then create decision-making guidelines that use NIRS monitoring to diagnose and direct treatment for ACS Information for this study will be collected in the hospital The study participants will be grouped into 2 categories
Cohort 1 Patients who are critically injured but have no lower leg injuries Cohort 2 Patients who have lower leg injuries that fall into certain high-energy categories see Eligibility Criteria Section 71
This is an observational study which means the data collected is not intended to impact the patients course of care At all points in time treatment will be directed by the patients doctor including decisions regarding operative care non-operative care and in-patient management In fact this study will be blinded which means that the doctor treating the study patients will not be able to see the NIRS values This study will enroll approximately 120 subjects over three sites Athens Regional Medical Center Atlanta Medical Center and Grady Memorial Hospital over a period of approximately 18 months Participation will last for 48 hours unless the patient develops signs of compartment syndrome in which case monitoring may be extended up to 72 hours or until completion of an assessment after the patient is treated for ACS
Participants will undergo the following procedures
Beyond the standard of care
1 Patient interview to collect information on medical history medications and mechanism of injury
2 Photographs will be taken to document NIRS pad placement over muscle compartments and injury severity face will not be included
3 Ultrasound measure of the thickness of the fat layer BX 2000 to detect the distance from the patients skin surface to the underlying muscle
4 Light scan measurement of skin color Dermaspectrometer to see if the patients skin color affects NIRS readings
5 Near-infrared Spectroscopy NIRS to measure patients muscle oxygen levels These devices are completely noninvasive which means there are no sharp or painful portions of the device or measurement process The NIRS device uses a small pad like an EKG pad that sticks to the patients skin and gives off a harmless painless light that can continually measure the patients muscle oxygen level These measures are recorded in the monitor and will later be downloaded and used to evaluate the devices ability to detect critical changes in muscle oxygen levels
Standard of care
1 Data will be recorded from the patients medical record based on procedures ordered by the patients provider including lab values Stryker measurements vital signs
2 Among Cohort 2 patients data associated with some surgical procedures will be collected and recorded in the operating room This will be data that is gathered as standard of care such as blood pressure
All of this information will be kept private and secure and no sensitive information will be collected
The NIRS device has already been cleared by the FDA for detecting blood flow to the brain during anesthesia NIRS may also be helpful in diagnosing ACS Two of the primary advantages of this device are that it is noninvasive not painful and it collects data continuously so that if the disease develops it can be detected early and treated appropriately In order to prove this the device must first be tested by taking a series of measurements on people that are uninjured control groups those with serious leg injuries investigational groups and people in a critically injured state but without leg injuries critical controls
The goal of this study is to collect the information necessary to understand and then create decision-making guidelines that use NIRS monitoring to diagnose and direct treatment for ACS Information for this study will be collected in the hospital The study participants will be grouped into 2 categories
Cohort 1 Patients who are critically injured but have no lower leg injuries Cohort 2 Patients who have lower leg injuries that fall into certain high-energy categories see Eligibility Criteria Section 71
This is an observational study which means the data collected is not intended to impact the patients course of care At all points in time treatment will be directed by the patients doctor including decisions regarding operative care non-operative care and in-patient management In fact this study will be blinded which means that the doctor treating the study patients will not be able to see the NIRS values This study will enroll approximately 120 subjects over three sites Athens Regional Medical Center Atlanta Medical Center and Grady Memorial Hospital over a period of approximately 18 months Participation will last for 48 hours unless the patient develops signs of compartment syndrome in which case monitoring may be extended up to 72 hours or until completion of an assessment after the patient is treated for ACS
Participants will undergo the following procedures
Beyond the standard of care
1 Patient interview to collect information on medical history medications and mechanism of injury
2 Photographs will be taken to document NIRS pad placement over muscle compartments and injury severity face will not be included
3 Ultrasound measure of the thickness of the fat layer BX 2000 to detect the distance from the patients skin surface to the underlying muscle
4 Light scan measurement of skin color Dermaspectrometer to see if the patients skin color affects NIRS readings
5 Near-infrared Spectroscopy NIRS to measure patients muscle oxygen levels These devices are completely noninvasive which means there are no sharp or painful portions of the device or measurement process The NIRS device uses a small pad like an EKG pad that sticks to the patients skin and gives off a harmless painless light that can continually measure the patients muscle oxygen level These measures are recorded in the monitor and will later be downloaded and used to evaluate the devices ability to detect critical changes in muscle oxygen levels
Standard of care
1 Data will be recorded from the patients medical record based on procedures ordered by the patients provider including lab values Stryker measurements vital signs
2 Among Cohort 2 patients data associated with some surgical procedures will be collected and recorded in the operating room This will be data that is gathered as standard of care such as blood pressure
All of this information will be kept private and secure and no sensitive information will be collected
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| A-158082 | OTHER | None | None |
| I100543 | OTHER | FDA | None |