Factors Increasing Air Burden in Intravenous Tubing

NCT ID: NCT03723408

Last Updated: 2018-10-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-16
• Study Completion Date: 2017-12-21

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.

Conditions

Air Embolism; Air Leakage; Air Burden

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Single Arm post-approval study

Single Arm post-approval study.

Group Type: OTHER

ClearLine IV (formerly, AirPurge)

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

AirPurge

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ClearLine MD

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher Tirotta, MD

Role: PRINCIPAL_INVESTIGATOR

Nicklaus Children's Hospital

Jonathan Ho, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Davinder Ramsingh, MD

Role: PRINCIPAL_INVESTIGATOR

Loma Linda Medical Center

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CLMD_CT_001

Identifier Type: -

Identifier Source: org_study_id