Factors Increasing Air Burden in Intravenous Tubing

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Air Embolism Air Burden Air Leakage Cardiovascular Diseases Embolism Embolism and Thrombosis Embolism, Air Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Any age - both pediatric and adult
Weight equal to or greater than 5kg
Surgical procedures
Cardiac catherization procedures
Minimum two hours procedure time

Exclusion criteria

Patient weight less than 5 kg
Procedures not involving surgery or cardiac catherization
Procedures less than two hours

Treatment and study plan

ClearLine IV (formerly, AirPurge)

Device

Patient safety device that automatically and continuously detects and actively removes air from IV lines - protecting patients from dangerous air burden, air embolism, air infusions.

Other names: AirPurge

Primary outcomes

The frequency of air removed from intravenous tubing by ClearLine IV

Time frame: 1 year

The ClearLine IV data monitor measures the frequency (# of air masses) of air removed from IV lines
The amount of air removed from intravenous tubing by ClearLine IV

Time frame: 1 year

The ClearLine IV data monitor measures the amount (mL) of air removed from IV lines

Sponsors and collaborators

Lead sponsor

ClearLine MD

Industry

Registry information

Official study title

A Prospective Observational Study of Air Burden in Intravenous Tubing: Factors That Increase Patient Risk

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Oct 29, 2018
Registry last updated: Oct 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed