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NCT04245553
Does Point of Care Ultrasound Change Needle Insertion Location During Routine Bedside Paracentesis?
NA trial testing Abdominal Point of Care Ultrasound in Ascites in 45 participants. Completed in 1 March 2021.
1 March 2021
Quick facts
| Lead sponsor | Steven Montague |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 45 |
| Start date | 7 February 2020 |
| Primary completion | 1 March 2021 |
| Estimated completion | 1 March 2021 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- Abdominal Point of Care Ultrasound
Conditions studied
- Ascites — all drugs for Ascites →
- Paracentesis — all drugs for Paracentesis →
- Point of Care Ultrasound (POCUS) — all drugs for Point of Care Ultrasound (POCUS) →
Sponsor
Steven Montague
Who can join
19 and older, any sex, with Ascites or Paracentesis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Paracentesis is a bedside procedure in which a needle is inserted into a patient's peritoneum in order to obtain ascitic fluid. This is a safe bedside procedure with very low risks of complications that is usually performed using physical exam maneuvers to determine the site of needle insertion. Point of care ultrasound (POCUS) technology has improved the safety of central venous catheter insertion and thoracentesis, yet the data on safety in paracentesis is equivocal. In a practical study, we aim to determine if POCUS will change the needle insertion site over the traditional anatomic landmarking method. Operators will landmark for paracentesis using conventional physical exam and then utilize POCUS to determine if there is a more optimal site. The primary endpoint will be whether POCUS yielded a change in the needle insertion site, as defined by a location greater than 5cm from the anatomic site, at least 20% of the time. The results will further our understanding of POCUS in improving procedural safety, thereby adding to the currently limited literature on this topic. Furthermore, this study will inform residency training programs about the utility in POCUS training for paracentesis and may advocate for the availability of POCUS devices to physicians performing this procedure.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Does Point-of-Care Ultrasound Change the Needle Insertion Location During Routine Bedside Paracentesis?
Rodrigues DM, Kundra A, Hookey L, Montague S. · · 2022 · cited 3× · PMID 34346007 · DOI 10.1007/s11606-021-07042-7
Verify or expand the search:
- PubMed search for NCT04245553
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04245553 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Steven Montague
- Last refreshed: 3 April 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04245553.
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