- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02301832
Reliability of Sensor Spacing for NIRS in Traumatic Tibia Fractures
3. februar 2017 opdateret af: 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).
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret 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.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
14
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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Georgia
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Atlanta, Georgia, Forenede Stater, 30303
- Grady Memorial Hospital
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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
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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 |
Foranstaltningsbeskrivelse |
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
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ICP measurements will be compared to NIRS values to assess the magnitude of accuracy between the 2 tools.
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Participants will be followed for the duration of hospital stay, an expected average of 72 hours
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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
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Compare NIRS values between non-injured and injured extremities
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Participants will be followed for the duration of hospital stay, an expected average of 72 hours
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: William Reisman, MD, Emory University
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. december 2014
Primær færdiggørelse (Faktiske)
20. juli 2016
Studieafslutning (Faktiske)
20. juli 2016
Datoer for studieregistrering
Først indsendt
24. november 2014
Først indsendt, der opfyldte QC-kriterier
25. november 2014
Først opslået (Skøn)
26. november 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
6. februar 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
3. februar 2017
Sidst verificeret
1. februar 2017
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IRB00075483
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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