- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04877886
TCHCCT-Zhong-Xing-Emergency-Department Ultrasound With IV Contrast in Acute Flank Pain
A Novel Technique for the Assessment of Non-traumatic Pain Diagnosis in the Emergency Department.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
Acute flank pain is a common chief complaint in emergency departments (ED), but it is a challenge for physicians in ED to accurately diagnose. It can cause variable diseases and is in many cases lethal (e.g. aortic dissection, ruptured aortic aneurysm, renal artery dissection, ruptured tumor, etc). The computed tomography scan with IV contrast is an ideal tool to diagnose due to its high sensitivity and specificity and is a golden standard examination. However, currently point-of-care ultrasound is routinely used as first-line technique. As this procedure is non-invasive and has no radiative effect, it is considered more logical, especially for those critical patients who are not able to move and perform the CT scan. Furthermore, the iodine contrast of CT scan is known as renal toxicity and should be used with caution in patient with hyperthyroidism and allergy to the contrast. The radiation of CT scan would be harmful to the pregnant patient as well.
IV contrast ultrasound is a novel technique nowadays and it is widely used in diagnosing breast, liver, renal and pancreatic tumors. The ultrasound contrast using air microbubbles could enhance the scanning quality and also has high sensitivity and specificity. In ED, ultrasound with contrast now could be applied to the abdominal trauma and pediatric injury. For those patients with poor renal function, thyroid disease and pregnant women who cannot undergo IV contrast CT, IV contrast ultrasound provides a faster and safer way to evaluate patients in ED. We compared CT and ultrasound with IV contrast to determine the difference in efficiency between both examinations.
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Tzu-Yao Hung, MD
- Telefonnummer: 886-979305599
- E-post: bryansolitude@gmail.com
Studiesteder
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Taipei, Taiwan, 100
- Taipei City Hospital Zhong-Xing branch
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Ta kontakt med:
- Tzu-Yao Hung, MD
- Telefonnummer: 886-2-979305599
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Acute flank pain who visit ER
Exclusion Criteria:
- Younger than 18 years old
- Known allergy to contrast
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Diagnostisk
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Ultrasound with IV contrast
use ultrasound with IV contrast to perform in acute flank pain patient
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To compare the efficiency over the ultrasound scan within contrast
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Aktiv komparator: CT with IV contrast
to compare with ultrasound with IV contrast in acute flank pain patient
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CT with IV contrast
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Aktiv komparator: Ultrasound without IV contrast
baseline for the Ultrasound with IV contrast
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Ultrasound without IV contrast
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Aktiv komparator: CT without IV contrast
baseline for the CT with IV contrast
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CT without IV contrast
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
The diagnostic rate of ultrasound with IV contrast in acute flank pain patient
Tidsramme: The hospitalization of each participant, up to 28 days
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Evaluate the sensitivity and specificity in ultrasound scan
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The hospitalization of each participant, up to 28 days
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
To compare the efficiency over the ultrasound and CT scan within or without contrast
Tidsramme: The hospitalization of each participant, up to 28 days
|
compared the sensitivity and specificity between CT and ultrasound scan
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The hospitalization of each participant, up to 28 days
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Tzu-Yao Hung, MD, Taipei City Hospital ZhongXing Branch
Studierekorddatoer
Studer hoveddatoer
Studiestart (Forventet)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- TCHCCT-ZXERUSC
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