- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Detaljeret 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.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Tzu-Yao Hung, MD
- Telefonnummer: 886-979305599
- E-mail: bryansolitude@gmail.com
Studiesteder
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Taipei, Taiwan, 100
- Taipei City Hospital Zhong-Xing branch
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Kontakt:
- Tzu-Yao Hung, MD
- Telefonnummer: 886-2-979305599
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Acute flank pain who visit ER
Exclusion Criteria:
- Younger than 18 years old
- Known allergy to contrast
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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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
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Tzu-Yao Hung, MD, Taipei City Hospital ZhongXing Branch
Datoer for undersøgelser
Studer store datoer
Studiestart (Forventet)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- TCHCCT-ZXERUSC
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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