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

Hospital Civil de Guadalajara

Status: Completed

Conditions: Critical Illness

Treatments: Procedure: Subclavian vein catheterization; Procedure: Innominate vein catheterization; Procedure: Internal jugular vein catheterization

Study type: Interventional

Funder types: Other

Identifiers

NCT04265703

HCG/CEI-1196/19

Details and patient eligibility

About

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

Full description

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.

Enrollment: 308 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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308 participants in 3 patient groups

Internal jugular vein site

Active Comparator group

Description:

Ultrasound-guided central venous catheterization at internal jugular vein site

Treatment:

Procedure: Internal jugular vein catheterization

Subclavian vein site

Active Comparator group

Description:

Ultrasound-guided central venous catheterization at subclavian vein site

Treatment:

Procedure: Subclavian vein catheterization

Innominate vein site

Active Comparator group

Description:

Ultrasound-guided central venous catheterization at innominate vein site

Treatment:

Procedure: Innominate vein catheterization