Air Embolism Clinical Trial
Official title:
A Prospective Observational Study of Air Burden in Intravenous Tubing: Factors That Increase Patient Risk
There is widespread acceptance that air in intravenous (IV) fluid tubing (lines) can pose a
significant risk to patients.1 A rigorous literature search regarding sources of this air
identified only anecdotal and non-clinical work regarding the presence and sources of air in
IV tubing. Most published case studies have focused on air entrainment from accidental or
inadvertent sources - empty IV fluid bags, incomplete priming of the tubing prior to
infusion, and air-detection device failures, as examples.
The sources (and volume) of air inside IV tubing during common surgical procedures or
interventions have yet to be studied prospectively. Understanding the frequency and magnitude
of the presence of unintended air in IV tubing is the first step in devising potential
avoidance strategies for eliminating unintended air in IV tubing. This study was designed to
identify both the sources and magnitude of air that occurs in IV tubing during routine
surgical procedures.
Methods:
An observational prospective trial was conducted in operating room settings across multiple
study sites. 120 surgical patients undergoing a variety of interventional and surgical
procedures were selected, representing multiple patient populations, case types and
anesthesia setups. The ClearLine IV, a device that detects and removes air from IV tubing,
was inserted into the IV circuit. Clinicians followed standard protocols. Blood warmers were
used at the practitioner's discretion. IV fluid was administered at a constant flow rate or
through a bolus given over 30-60 seconds per standard of care. The volume and duration of
fluid administration was recorded, along with the frequency, duration and amount of air
captured by ClearLine IV.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT02340741 -
Insufflation of Carbon Dioxide During Cardiac Surgery as Prevention Neurologic Complications
|
N/A | |
Recruiting |
NCT06168539 -
Reduction of Microemboli of Air Using a New Developed Air Trap (EmbolessTM) During Haemodialysis
|
N/A | |
Completed |
NCT05820828 -
Comparing Air Embolic Load in Two Venous Cannulation Methods, 40 Patients Undergoing Elective Valve Surgery.
|
N/A |