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
About this trial
This is an interventional prevention trial for Air Embolism
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
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
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
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Factors Increasing Air Burden in Intravenous Tubing
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