A Prospective Observational Study of Air Burden in Intravenous Tubing: Factors That Increase Patient Risk
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- ClearLine MD
- 入组人数
- 120
- 主要终点
- The frequency of air removed from intravenous tubing by ClearLine IV
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
盲法说明
Three sites - Loma Linda Medical Center, Johns Hopkins, Miami Nicklaus Children's
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Any age - both pediatric and adult
- •Weight equal to or greater than 5kg
- •Surgical procedures
- •Cardiac catherization procedures
- •Minimum two hours procedure time
排除标准
- •Patient weight less than 5 kg
- •Procedures not involving surgery or cardiac catherization
- •Procedures less than two hours
研究组 & 干预措施
Single Arm post-approval study
Single Arm post-approval study.
干预措施: ClearLine IV (formerly, AirPurge) (Device)
结局指标
主要结局
The frequency of air removed from intravenous tubing by ClearLine IV
时间窗: 1 year
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
时间窗: 1 year
The ClearLine IV data monitor measures the amount (mL) of air removed from IV lines
次要结局
未报告次要终点