MedTrace Logo

Factors Increasing Air Burden in Intravenous Tubing

NCT03723408 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2018-10-29

No results posted yet for this study

Summary

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.

Conditions

  • Air Embolism
  • Air Leakage
  • Air Burden

Interventions

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.

Sponsors & Collaborators

  • ClearLine MD

    lead INDUSTRY

Principal Investigators

  • Christopher Tirotta, MD · Nicklaus Children's Hospital

  • Jonathan Ho, MD · Johns Hopkins University

  • Davinder Ramsingh, MD · Loma Linda Medical Center

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-08-16
Primary Completion
2017-12-21
Completion
2017-12-21
FDA Device
Yes

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03723408 on ClinicalTrials.gov