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Factors Increasing Air Burden in Intravenous Tubing

Primary Purpose

Air Embolism, Air Leakage, Air Burden

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ClearLine IV (formerly, AirPurge)
Sponsored by
ClearLine MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Air Embolism

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Single Arm post-approval study

    Arm Description

    Single Arm post-approval study.

    Outcomes

    Primary Outcome Measures

    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
    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

    Secondary Outcome Measures

    Full Information

    First Posted
    October 24, 2018
    Last Updated
    October 26, 2018
    Sponsor
    ClearLine MD
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03723408
    Brief Title
    Factors Increasing Air Burden in Intravenous Tubing
    Official Title
    A Prospective Observational Study of Air Burden in Intravenous Tubing: Factors That Increase Patient Risk
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    August 16, 2016 (Actual)
    Primary Completion Date
    December 21, 2017 (Actual)
    Study Completion Date
    December 21, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    ClearLine MD

    4. Oversight

    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
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Air Embolism, Air Leakage, Air Burden

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    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)
    Masking Description
    Three sites - Loma Linda Medical Center, Johns Hopkins, Miami Nicklaus Children's
    Allocation
    N/A
    Enrollment
    120 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Single Arm post-approval study
    Arm Type
    Other
    Arm Description
    Single Arm post-approval study.
    Intervention Type
    Device
    Intervention Name(s)
    ClearLine IV (formerly, AirPurge)
    Other Intervention Name(s)
    AirPurge
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    The frequency of air removed from intravenous tubing by ClearLine IV
    Description
    The ClearLine IV data monitor measures the frequency (# of air masses) of air removed from IV lines
    Time Frame
    1 year
    Title
    The amount of air removed from intravenous tubing by ClearLine IV
    Description
    The ClearLine IV data monitor measures the amount (mL) of air removed from IV lines
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Christopher Tirotta, MD
    Organizational Affiliation
    Nicklaus Children's Hospital
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Jonathan Ho, MD
    Organizational Affiliation
    Johns Hopkins University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Davinder Ramsingh, MD
    Organizational Affiliation
    Loma Linda Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Factors Increasing Air Burden in Intravenous Tubing

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