Factors Increasing Air Burden in Intravenous Tubing

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Air Embolism, Air Leakage, Air Burden

Intervention / Treatment
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* Device: ClearLine IV (formerly, AirPurge)


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single Arm post-approval study<br>Single Arm post-approval study. | Device: ClearLine IV (formerly, AirPurge)<br>* 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.<br>* Other names: AirPurge;|

What is the study measuring?
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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 |