Central Venous Access in Patients With Difficult Cannulation, A Randomized Controlled Trial
概览
- 阶段
- 不适用
- 干预措施
- Internal jugular vein catheterization
- 疾病 / 适应症
- Critical Illness
- 发起方
- Hospital Civil de Guadalajara
- 入组人数
- 315
- 试验地点
- 1
- 主要终点
- Cannulation failure rate
- 状态
- 招募中
- 最后更新
- 上个月
概览
简要总结
Most recent guidelines suggest central venous access must be performed with real-time ultrasound guidance, and the most recommended site for cannulation is internal jugular vein (IJV); however, it is recognized that evidence for other sites is, at present, limited. Besides, guidelines does not account for patients with small vein cross-sectional area and/or respirophasic collapse, which can make the procedure more difficult or even impossible. The investigators aim to compare three different insertion sites for central venous access, with real-time ultrasound guidance
详细描述
Ultrasound-guided cannulation of central veins is successful in \>95% of the cases, according to the largest study so far. However, this and other studies with similar success rate, are performed in patients with general anesthesia and/or neuromuscular blockade, without spontaneous respiratory efforts. Critical care physicians and many other specialists frequently need to cannulate patients in special circumstances as hypovolemia, pain, anxiety, and respiratory efforts that promotes respirophasic variation in cross-sectional area, and even complete collapse of the vessel. These changes can increase the probability of posterior wall or arterial puncture, hematomas, pneumothorax, etc. Supraclavicular approach for cannulation of the subclavian vein is a method described since 1965, also giving direct access to the innominate vein, a larger vessel which is rarely collapsible regardless of volume status or respiratory efforts. Based on a previous pilot trial, in this multi-center, prospective, randomized, controlled trial, the investigators aim to compare the successfulness and safety of ultrasound-guided central venous cannulation at 3 different sites: internal jugular, subclavian, and innominate veins.
研究者
Miguel Á Ibarra-Estrada
Principal Investigator
Hospital Civil de Guadalajara
入排标准
入选标准
- •Patients who need central venous catheterization, and have respirophasic variation in cross-sectional area of jugular veins
排除标准
- •Less than 18 years-old
- •Patients with previous failed attempts with non-ultrasound guided technique
- •Non-resolved pneumothorax/hemothorax at enrollment
- •Refusal to sign informed consent
研究组 & 干预措施
Internal jugular vein site
Ultrasound-guided central venous catheterization at internal jugular vein site
干预措施: Internal jugular vein catheterization
Subclavian vein site
Ultrasound-guided central venous catheterization at subclavian vein site
干预措施: Subclavian vein catheterization
Innominate vein site
Ultrasound-guided central venous catheterization at innominate vein site
干预措施: Innominate vein catheterization
结局指标
主要结局
Cannulation failure rate
时间窗: Baseline
Failure to cannulate selected vein at first attempt
次要结局
- Hematoma formation rate(7 days)
- Central line-associated blood infection rate(28 days)
- Collapsibility associated with failure(Baseline)
- Cannulation number of attempts(Baseline)
- Procedure time(Baseline)
- Arterial puncture rate(Baseline)
- Hemothorax rate(7 days)
- Neumothorax rate(7 days)