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Factors Increasing Air Burden in Intravenous Tubing

C

ClearLine MD

Status

Completed

Conditions

Air Burden
Air Embolism
Air Leakage

Treatments

Device: ClearLine IV (formerly, AirPurge)

Study type

Interventional

Funder types

Industry

Identifiers

NCT03723408
CLMD_CT_001

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 patients

Sex

All

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

120 participants in 1 patient group

Single Arm post-approval study
Other group
Description:
Single Arm post-approval study.
Treatment:
Device: ClearLine IV (formerly, AirPurge)

Trial documents
1

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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