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
About this trial
This is an interventional supportive care trial for Ascites focused on measuring Paracentesis, Point of Care Ultrasound (POCUS)
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
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
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
Learn more about this trial
Does Point of Care Ultrasound Change Needle Insertion Location During Routine Bedside Paracentesis?
We'll reach out to this number within 24 hrs