Factors Increasing Air Burden in Intravenous Tubing

NCT03723408 | Completed FDA Device

• 1 other identifier: CLMD_CT_001
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Air Embolism; Air Leakage; Air Burden

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Single Arm post-approval study

OTHER

Single Arm post-approval study.

Device: ClearLine IV (formerly, AirPurge)

Interventions

ClearLine IV (formerly, AirPurge) DEVICE

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.

Also known as: AirPurge

Single Arm post-approval study

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Any age - both pediatric and adult
• Weight equal to or greater than 5kg
• Surgical procedures
• Cardiac catherization procedures
• Minimum two hours procedure time

You may not qualify if:

• Patient weight less than 5 kg
• Procedures not involving surgery or cardiac catherization
• Procedures less than two hours

Sponsors & Collaborators

• ClearLine MD: lead

MeSH Terms

Conditions

Embolism, Air

Condition Hierarchy (Ancestors)

Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Christopher Tirotta, MD

  Nicklaus Children's Hospital

  PRINCIPAL INVESTIGATOR

• Jonathan Ho, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• Davinder Ramsingh, MD

  Loma Linda Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Three sites - Loma Linda Medical Center, Johns Hopkins, Miami Nicklaus Children's
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 24, 2018
• First Posted: October 29, 2018
• Study Start: August 16, 2016
• Primary Completion: December 21, 2017
• Study Completion: December 21, 2017
• Last Updated: October 29, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share