Does Point of Care Ultrasound Change Needle Insertion Location During Routine Bedside Paracentesis?

Ascites Clinical Trial

Official title:

Does Point of Care Ultrasound Change Needle Insertion Location During Routine Bedside Paracentesis?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04245553
• Other study ID #: 6028481
• Status: Completed
• Phase: N/A
• Start date: February 7, 2020
• Est. completion date: March 1, 2021

Study information

• Verified date: April 2024
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: March 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

This is in effort to capture routine paracentesis cases.

Inclusion Criteria:

• Participants scheduled to have either a diagnostic of therapeutic paracentesis.
• Participants can be either inpatients under the care of general internal medicine, or outpatients under the care of gastroenterology or general internal medicine.
• Operators will be recruited on a volunteer basis and will include medical residents or subspecialty fellows with knowledge of POCUS for paracentesis purposes, either through core residency programs or more advanced training.

Exclusion Criteria:

• Loculated ascites
• Current anticoagulation
• Hemodynamic instability
• Bowel obstruction
• Pregnancy
• Abdominal wall cellulitis
• Platelet count <20

Related Conditions & MeSH terms

• Ascites
• Paracentesis
• Point of Care Ultrasound (POCUS)

Intervention

Diagnostic Test:
• Abdominal Point of Care Ultrasound
Participants will be have their needle insertion site for a paracentesis land-marked using both the traditional anatomical method, and with a point of care ultrasound. Note that the current standard of care does not require the use of point of care ultrasound.

Locations

Country	Name	City	State
Canada	Kingston Health Sciences Center	Kingston	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Steven Montague

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preference of land-marking method	Does the clinician performing the procedure prefer the needle insertion site found using point of care ultrasound, or using the traditional anatomic method. A clinically significant difference in location is defined as greater than or equal to 5cm apart. If the difference in locations is not at least 5cm apart, this will be defined as no preference in land-marking methods.	Determined immediatly after the POCUS landmarking is done.
Secondary	Depth of Ascitis	Depth of ascitis, measured perpendicular to the overlying skin, at the location land-marked using traditional anatomic method, versus the location found with point of care ultrasound.	Determined immediatly after the POCUS landmarking is done.
Secondary	Immediate Complications	The overall rate of any complications observed while performing the procedure. This includes bleeding, perforation/puncture of any internal organ, or a failed attempt.	Occuring at any time between the needle insertion and removal of the paracentesis drain.