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

Primary Purpose

Ascites, Paracentesis, Point of Care Ultrasound (POCUS)

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Abdominal Point of Care Ultrasound
Sponsored by
Queen's University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Ascites focused on measuring Paracentesis, Point of Care Ultrasound (POCUS)

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kingston Health Sciences Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All Participants

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
January 25, 2020
Last Updated
March 8, 2021
Sponsor
Queen's University
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1. Study Identification

Unique Protocol Identification Number
NCT04245553
Brief Title
Does Point of Care Ultrasound Change Needle Insertion Location During Routine Bedside Paracentesis?
Official Title
Does Point of Care Ultrasound Change Needle Insertion Location During Routine Bedside Paracentesis?
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
February 7, 2020 (Actual)
Primary Completion Date
March 1, 2021 (Actual)
Study Completion Date
March 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen's University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ascites, Paracentesis, Point of Care Ultrasound (POCUS)
Keywords
Paracentesis, Point of Care Ultrasound (POCUS)

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
All Participants
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
Abdominal Point of Care Ultrasound
Intervention Description
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.
Primary Outcome Measure Information:
Title
Preference of land-marking method
Description
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.
Time Frame
Determined immediatly after the POCUS landmarking is done.
Secondary Outcome Measure Information:
Title
Depth of Ascitis
Description
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.
Time Frame
Determined immediatly after the POCUS landmarking is done.
Title
Immediate Complications
Description
The overall rate of any complications observed while performing the procedure. This includes bleeding, perforation/puncture of any internal organ, or a failed attempt.
Time Frame
Occuring at any time between the needle insertion and removal of the paracentesis drain.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Montague, MD
Organizational Affiliation
Queen's University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kingston Health Sciences Center
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7K2V7
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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

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