- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Tzu-Yao Hung, MD
- Telefonnummer: 886-979305599
- E-post: bryansolitude@gmail.com
Studieorter
-
-
-
Taipei, Taiwan, 100
- Taipei City Hospital Zhong-Xing branch
-
Kontakt:
- Tzu-Yao Hung, MD
- Telefonnummer: 886-2-979305599
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Acute flank pain who visit ER
Exclusion Criteria:
- Younger than 18 years old
- Known allergy to contrast
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Diagnostisk
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Ultrasound with IV contrast
use ultrasound with IV contrast to perform in acute flank pain patient
|
To compare the efficiency over the ultrasound scan within contrast
|
|
Aktiv komparator: CT with IV contrast
to compare with ultrasound with IV contrast in acute flank pain patient
|
CT with IV contrast
|
|
Aktiv komparator: Ultrasound without IV contrast
baseline for the Ultrasound with IV contrast
|
Ultrasound without IV contrast
|
|
Aktiv komparator: CT without IV contrast
baseline for the CT with IV contrast
|
CT without IV contrast
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
The diagnostic rate of ultrasound with IV contrast in acute flank pain patient
Tidsram: The hospitalization of each participant, up to 28 days
|
Evaluate the sensitivity and specificity in ultrasound scan
|
The hospitalization of each participant, up to 28 days
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
To compare the efficiency over the ultrasound and CT scan within or without contrast
Tidsram: The hospitalization of each participant, up to 28 days
|
compared the sensitivity and specificity between CT and ultrasound scan
|
The hospitalization of each participant, up to 28 days
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Tzu-Yao Hung, MD, Taipei City Hospital ZhongXing Branch
Studieavstämningsdatum
Studera stora datum
Studiestart (Förväntat)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- TCHCCT-ZXERUSC
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .