Factors Increasing Air Burden in Intravenous Tubing

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.

Study Overview

• Status: Completed
• Conditions: Air Leakage; Air Embolism; Air Burden
• Intervention / Treatment: Device: ClearLine IV (formerly, AirPurge)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Single Arm post-approval study; Single Arm post-approval study.	Device: ClearLine IV (formerly, AirPurge); 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The frequency of air removed from intravenous tubing by ClearLine IV	The ClearLine IV data monitor measures the frequency (# of air masses) of air removed from IV lines	1 year
The amount of air removed from intravenous tubing by ClearLine IV	The ClearLine IV data monitor measures the amount (mL) of air removed from IV lines	1 year

Collaborators and Investigators

• Sponsor: ClearLine MD
• Investigators: Principal Investigator: Christopher Tirotta, MD, Nicklaus Children's Hospital; Principal Investigator: Jonathan Ho, MD, Johns Hopkins University; Principal Investigator: Davinder Ramsingh, MD, Loma Linda Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2016
• Primary Completion (Actual): December 21, 2017
• Study Completion (Actual): December 21, 2017

Study Registration Dates

• First Submitted: October 24, 2018
• First Submitted That Met QC Criteria: October 26, 2018
• First Posted (Actual): October 29, 2018

Study Record Updates

• Last Update Posted (Actual): October 29, 2018
• Last Update Submitted That Met QC Criteria: October 26, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Embolism; Embolism, Air
• Other Study ID Numbers: CLMD_CT_001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes