Orthopedic DisordersNCT02301832
Reliability of Sensor Spacing for NIRS in Traumatic Tibia Fractures
An observational study of Orthopedic Disorders and Tibial Fractures, run by Emory University at 1 site in United States.
Trial summary
This is a study intended to evaluate a non-invasive device that uses light to measure the amount of oxygen in the muscles of injured and non-injured legs in specific situations. The name of this technology is NIRS (near-infrared spectroscopy). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Orthopedic Disorders, Tibial Fractures
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to 20 Jul 2016
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects will be recruited from the trauma bay, surgical wards and ICU of Grady Memorial Hospital.
Who may be able to join
- Unilateral leg injury
- Enrolled within 48 hours of injury
- Subjects with 'severe' leg injuries presenting at trauma center that meet at least one of the following from each group below:
- Anatomic location:
- Tibia/Fibula shaft fracture
- Tibial plateau fracture (Schatzker III-VI)
Show all 13Show fewer
- High Energy Mechanism of Injury:
- Fall from >8 foot height
- Motor vehicle collision (> 15 mph)
- Motor vehicle versus pedestrian accident
- High velocity gunshot wound
- Crush injury
- Sport/recreation
Who cannot join
- Application of NIRS monitoring would be an impediment to care
- Known prior leg fractures, patient has already undergone fasciotomy of the injured leg prior to enrollment
- History of peripheral vascular disease or concurrent lower extremity vascular injury/surgery
- Admission for atraumatic medical reasons
- Subject is unable to provide informed consent, or consent cannot be obtained from a legally authorized representative
- Complete spinal cord injuries, bilateral upper extremity injuries, or amputation/mangled lower extremity
Show all 10Show fewer
- Patients who are in police custody at presentation to the hospital or who are pregnant
- Patient has an open injury on the injured leg that is large enough that at least one NIRS sensor cannot be safely placed over the compartment
- Bilateral leg injuries
- Not able to be enrolled within 48 hours after injury
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reliability of Sensor Spacing for Near Infrared Spectroscopy in Traumatic Tibia Fractures: An Observational Study
This is a study intended to evaluate a non-invasive device that uses light to measure the amount of oxygen in the muscles of injured and non-injured legs in specific situations. The name of this technology is NIRS (near-infrared spectroscopy). The goal of this study is to collect the information necessary to understand the use of the NIRS monitoring system to diagnose and direct treatment decisions in case of complications sometimes experienced in traumatic tibia fracture, such as excessive swelling called acute compartment syndrome (ACS).
Read the detailed description
This study seeks to further develop the use of NIRS technology in the diagnosis of acute compartment syndrome. NIRS values normally increase in traumatized legs compared to the contralateral uninjured leg or forearm, indicative of a hyperemic response. The investigators hopes to build upon the current knowledge and verify the ability to accurately detect ACS using two easily identified and accessible leg compartments, the anterior and superficial posterior utilizing the Nonin 7600 oximeter with the Sensor Model 8004CV. Additionally, since this device was originally designed with brain tissue in mind, the NIRS device will collect vital engineering data that will be used to validate the algorithm used to produce the oxygenation values in injured muscle tissue.
- Conditions
- Orthopedic Disorders, Tibial Fractures
- Keywords
- acute compartment swelling (ACS), near-infrared spectroscopy (NIRS)
- Medical subject headings
- Musculoskeletal Diseases, Tibial Fractures
What is being measured
The primary outcome is the main question the study is designed to answer.
NIRS measurements as compared to clinical findings
Assess the accuracy of the Nonin 7600 oximeter with the Sensor Model 8004CV in the diagnosis of Acute Compartment Syndrome, using the "gold standard" criterion for ACS, which will be "clinical diagnosis". That is, all subjects undergoing fasciotomy for clinically diagnosed ACS will be considered to have ACS. NIRS values will be compared to clinical diagnosis to determine accuracy and threshold values.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 72 hours
Secondary outcomes (2)
Accuracy of NIRS measurements compared to Intracompartmental pressure (ICP) measurements
ICP measurements will be compared to NIRS values to assess the magnitude of accuracy between the 2 tools.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 72 hours
Correlation between NIRS measurements between injured and uninjured extremity
Compare NIRS values between non-injured and injured extremities
Measured: Participants will be followed for the duration of hospital stay, an expected average of 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2014 (estimated)
- Study startDec 2014
- Primary completion20 Jul 2016
- Study completion20 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopedic DisordersStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Reisman, Emory University
- Investigators
- William Reisman, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02301832
- Sponsor's protocol ID
- IRB00075483
- Status last verified
- Feb 2017
- First submitted
- 24 Nov 2014
- Last updated
- 6 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability of Sensor Spacing for Near Infrared Spectroscopy in Traumatic Tibia Fractures: An Observational Study
- ClinicalTrials.gov ID
- NCT02301832
- Acronym / sponsor ID
- IRB00075483
- Conditions
- Orthopedic Disorders, Tibial Fractures
- Keywords
- acute compartment swelling (ACS), near-infrared spectroscopy (NIRS)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Dec 2014 (actual)
- Primary completion
- 20 Jul 2016 (actual)
- Study completion
- 20 Jul 2016 (actual)
- First posted
- 26 Nov 2014 (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 study intended to evaluate a non-invasive device that uses light to measure the amount of oxygen in the muscles of injured and non-injured legs in specific situations. The name of this technology is NIRS (near-infrared spectroscopy). The goal of this study is to collect the information necessary to understand the use of the NIRS monitoring system to diagnose and direct treatment decisions in case of complications sometimes experienced in traumatic tibia fracture, such as excessive swelling called acute compartment syndrome (ACS).
Detailed description
This study seeks to further develop the use of NIRS technology in the diagnosis of acute compartment syndrome. NIRS values normally increase in traumatized legs compared to the contralateral uninjured leg or forearm, indicative of a hyperemic response. The investigators hopes to build upon the current knowledge and verify the ability to accurately detect ACS using two easily identified and accessible leg compartments, the anterior and superficial posterior utilizing the Nonin 7600 oximeter with the Sensor Model 8004CV. Additionally, since this device was originally designed with brain tissue in mind, the NIRS device will collect vital engineering data that will be used to validate the algorithm used to produce the oxygenation values in injured muscle tissue.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be recruited from the trauma bay, surgical wards and ICU of Grady Memorial Hospital.
Key inclusion criteria (13 listed)
- Unilateral leg injury
- Enrolled within 48 hours of injury
- Subjects with 'severe' leg injuries presenting at trauma center that meet at least one of the following from each group below:
- Tibia/Fibula shaft fracture
- Tibial plateau fracture (Schatzker III-VI)
Key exclusion criteria (10 listed)
- Application of NIRS monitoring would be an impediment to care
- Known prior leg fractures, patient has already undergone fasciotomy of the injured leg prior to enrollment
- History of peripheral vascular disease or concurrent lower extremity vascular injury/surgery
- Admission for atraumatic medical reasons
- Subject is unable to provide informed consent, or consent cannot be obtained from a legally authorized representative
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
NIRS measurements as compared to clinical findings
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 72 hours
Assess the accuracy of the Nonin 7600 oximeter with the Sensor Model 8004CV in the diagnosis of Acute Compartment Syndrome, using the "gold standard" criterion for ACS, which will be "clinical diagnosis". That is, all subjects undergoing fasciotomy for clinically diagnosed ACS will be considered to have ACS. NIRS values will be compared to clinical diagnosis to determine accuracy and threshold values.
2 secondary outcomes
Accuracy of NIRS measurements compared to Intracompartmental pressure (ICP) measurements
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 72 hours
Correlation between NIRS measurements between injured and uninjured extremity
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 72 hours
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 6 Feb 2017.
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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.
William Reisman, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Orthopedic Disorders and Tibial Fractures, run by Emory University at 1 site 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 13 inclusion and 10 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 6 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
NIRS measurements as compared to clinical findings (time frame: Participants will be followed for the duration of hospital stay, an expected average of 72 hours). 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 6 Feb 2017.