Clinical trial NCT04245553: 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
Overall status: COMPLETED
Phase: NA
Conditions: Ascites
Paracentesis
Point of Care Ultrasound (POCUS)
Keywords: Paracentesis
Point of Care Ultrasound (POCUS)
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2020-01-29
Enrollment: 45
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Preference of land-marking method
timeFrame: Determined immediatly after the POCUS landmarking is done.
Secondary outcomes:
measure: Depth of Ascitis
timeFrame: Determined immediatly after the POCUS landmarking is done.
measure: Immediate Complications
timeFrame: Occuring at any time between the needle insertion and removal of the paracentesis drain.
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Kingston Health Sciences Center
state: Ontario
Study officials:
affiliation: Queen's University
name: Steven Montague, MD
role: PRINCIPAL_INVESTIGATOR
References: