The INVADE Study: INnominate Vein Approach for Central Catheterization in Difficult to cannulatE Patients

Официальное название

Central Venous Access in Patients With Difficult Cannulation, A Randomized Controlled Trial

Обзор

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

Подробное описание

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.

Вмешательства

• Процедура Internal jugular vein catheterization
  Catheterization of internal jugular vein with real-time (in-plane) method, with neutral neck position. Standard aseptic technique.
• Процедура Subclavian vein catheterization
  Catheterization of subclavian/axillary vein with infra-clavicular approach with real-time (in-plane) method, without shoulder retraction. Standard aseptic technique.
• Процедура Innominate vein catheterization
  Catheterization of innominate vein with supra-clavicular approach with real-time (in-plane) method, with neutral shoulder position and no shoulder retraction. Standard aseptic technique.

Первичные конечные точки

• Cannulation failure rate [Срок оценки: Baseline]

Вторичные конечные точки (8)

• Central line-associated blood infection rate [Срок оценки: 28 days]
• Collapsibility associated with failure [Срок оценки: Baseline]
• Cannulation number of attempts [Срок оценки: Baseline]
• Procedure time [Срок оценки: Baseline]
• Arterial puncture rate [Срок оценки: Baseline]
• Hematoma formation rate [Срок оценки: 7 days]
• Neumothorax rate [Срок оценки: 7 days]
• Hemothorax rate [Срок оценки: 7 days]

Критерии участия

Критерии включения

• Patients who need central venous catheterization, and have respirophasic variation in cross-sectional area of jugular veins

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Мексика · 1 центр

• Hospital Civil Fray Antonio Alcalde — Guadalajara

Идентификаторы

NCT: NCT04265703 · HCG/CEI-1196/19

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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