Reliability of Sensor Spacing for NIRS in Traumatic Tibia Fractures
3. februar 2017 oppdatert av: William Reisman, Emory University
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).
Studieoversikt
Status
Fullført
Forhold
Detaljert beskrivelse
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.
Studietype
Observasjonsmessig
Registrering (Faktiske)
14
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Georgia
-
Atlanta, Georgia, Forente stater, 30303
- Grady Memorial Hospital
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 65 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Subjects will be recruited from the trauma bay, surgical wards and ICU of Grady Memorial Hospital.
Beskrivelse
Inclusion Criteria:
- 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)
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
Exclusion Criteria:
- 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
- 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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
NIRS measurements as compared to clinical findings
Tidsramme: 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.
|
Participants will be followed for the duration of hospital stay, an expected average of 72 hours
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Accuracy of NIRS measurements compared to Intracompartmental pressure (ICP) measurements
Tidsramme: Participants will be followed for the duration of hospital stay, an expected average of 72 hours
|
ICP measurements will be compared to NIRS values to assess the magnitude of accuracy between the 2 tools.
|
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
Tidsramme: Participants will be followed for the duration of hospital stay, an expected average of 72 hours
|
Compare NIRS values between non-injured and injured extremities
|
Participants will be followed for the duration of hospital stay, an expected average of 72 hours
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: William Reisman, MD, Emory University
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. desember 2014
Primær fullføring (Faktiske)
20. juli 2016
Studiet fullført (Faktiske)
20. juli 2016
Datoer for studieregistrering
Først innsendt
24. november 2014
Først innsendt som oppfylte QC-kriteriene
25. november 2014
Først lagt ut (Anslag)
26. november 2014
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
6. februar 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
3. februar 2017
Sist bekreftet
1. februar 2017
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IRB00075483
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .