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

  • STATUS
    Recruiting
  • End date
    Dec 29, 2022
  • participants needed
    240
  • sponsor
    Hospital Civil de Guadalajara
Updated on 26 February 2022

Summary

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

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.

Details
Condition Critical Illness
Treatment Internal jugular vein catheterization, Subclavian vein catheterization, Innominate vein catheterization
Clinical Study IdentifierNCT04265703
SponsorHospital Civil de Guadalajara
Last Modified on26 February 2022

Eligibility

Yes No Not Sure

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
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