Clinical trial NCT04265703: The INVADE Study: INnominate Vein Approach for Central Catheterization in Difficult to cannulatE Patients
Official title: Central Venous Access in Patients With Difficult Cannulation, A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Critical Illness
Keywords: Central venous access
Ultrasound-guided catheterization
Innominate vein
Brachiocephalic vein
Lead sponsor: Hospital Civil de Guadalajara
Sponsor class: OTHER
Collaborators: name: Instituto Jalisciense de Cancerologia
First posted: 2020-02-11
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Cannulation failure rate
timeFrame: Baseline
Secondary outcomes:
measure: Central line-associated blood infection rate
timeFrame: 28 days
measure: Collapsibility associated with failure
timeFrame: Baseline
measure: Cannulation number of attempts
timeFrame: Baseline
measure: Procedure time
timeFrame: Baseline
measure: Arterial puncture rate
timeFrame: Baseline
measure: Hematoma formation rate
timeFrame: 7 days
measure: Neumothorax rate
timeFrame: 7 days
measure: Hemothorax rate
timeFrame: 7 days
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Hospital Civil Fray Antonio Alcalde
Study officials:
affiliation: Hospital Civil Fray Antonio Alcalde
name: Miguel Ibarra-Estrada, MD
role: PRINCIPAL_INVESTIGATOR
References: