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

NCT ID: NCT04245553

Last Updated: 2024-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-07
• Study Completion Date: 2021-03-01

Brief 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.

Conditions

Ascites; Paracentesis; Point of Care Ultrasound (POCUS)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

All Participants

Group Type: EXPERIMENTAL

Abdominal Point of Care Ultrasound

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Steven Montague

OTHER

Sponsor Role: lead

Responsible Party

Steven Montague

Medical Doctor, Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Steven Montague, MD

Role: PRINCIPAL_INVESTIGATOR

Queen's University

Locations

Kingston Health Sciences Center

Kingston, Ontario, Canada

Countries

Canada

Other Identifiers

6028481

Identifier Type: -

Identifier Source: org_study_id