A Study to Validate a New Set of Guidelines for a Device that Uses Light to Measure the Amount of Oxygen in the Muscles of Injured and Non-injured Legs and Forearms in Specific Situations
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 17-001290
Sponsor Protocol Number: 17-001290
About this study
The purpose of this study is to validate diagnosing acute compartment syndrome (ACS) using clinical guidelines consisting of continuous near infrared spectroscopy (NIRS) values in combination with clinical standards, established by the research team based on prior work, in comparison to intramuscular pressures and clinical diagnosis among injured extremities.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Aged 18 to 65 years
- Ability to be enrolled within 12 hours of qualifying injury
- Must have at least one uninjured upper or lower extremity
- Must have a “severe leg injury” meeting one of the following anatomical locations and mechanisms of injury.
Exclusion Criteria:
- Application of NIRS monitoring would be an impediment to care
- Known prior injury, surgery, or disease of the lower extremity (including thigh) that alters normal circulation in the leg (including peripheral vascular disease)
- Admission for atraumatic medical reasons (i.e. myocardial infarction, sepsis)
- Consent cannot be obtained from the patient or their LAR within 12 hours of injury
- Has already undergone fasciotomy of the injured leg prior to enrollment
- Has spinal injuries that result in complete loss of function (complete spinal cord injuries)
- Has bilateral upper and lower extremity injuries greater than simple soft tissue injuries
- Is in police custody at presentation to the hospital
- Is a woman who is pregnant
- Has open injury on the injured leg that is large enough that at least two NIRS sensor cannot be safely placed. At a minimum two sensors must be placed on the injured leg(s).
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Brandon Yuan, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available