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

NCT04245553 | Completed

• 1 other identifier: 6028481
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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)

Keywords

Paracentesis; Point of Care Ultrasound (POCUS)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Depth of Ascitis

  Determined immediatly after the POCUS landmarking is done.

• Immediate Complications

  Occuring at any time between the needle insertion and removal of the paracentesis drain.

Study Arms (1)

All Participants

EXPERIMENTAL

Diagnostic Test: Abdominal Point of Care Ultrasound

Interventions

Abdominal Point of Care Ultrasound 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.

All Participants

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Steven Montague: lead

Study Sites (1)

Kingston Health Sciences Center

Kingston, Ontario, K7K2V7, Canada

Location

MeSH Terms

Conditions

Ascites

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Steven Montague, MD

  Queen's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Doctor, Assistant Professor

Study Record Dates

• First Submitted: January 25, 2020
• First Posted: January 29, 2020
• Study Start: February 7, 2020
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: April 3, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)