Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04265703

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

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

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Civil Fray Antonio Alcalde

Guadalajara, 44280, Mexico

Location status: Recruiting

Location contact

Arnulfo López-Pulgarín, MD

SUB_INVESTIGATOR

Guadalupe Aguirre-Avalos, MD

CONTACT

[email protected]

Guadalupe Aguirre-Avalos, MD

SUB_INVESTIGATOR

Miguel Ibarra-Estrada, MD

CONTACT

[email protected]

3317593502

Miguel Ibarra-Estrada, MD

PRINCIPAL_INVESTIGATOR

Pável Aguilera-González, MD

SUB_INVESTIGATOR

Quetzalcóatl Chávez-Peña, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Internal Jugular Vein Catheterization

Procedure

Catheterization of internal jugular vein with real-time (in-plane) method, with neutral neck position. Standard aseptic technique.

subclavian vein catheterization

Procedure

Catheterization of subclavian/axillary vein with infra-clavicular approach with real-time (in-plane) method, without shoulder retraction. Standard aseptic technique.

Innominate vein catheterization

Procedure

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.

Primary outcomes

  1. Cannulation failure rate

    Time frame: Baseline

    Failure to cannulate selected vein at first attempt

Secondary outcomes

  1. Central line-associated blood infection rate

    Time frame: 28 days

    Confirmed with blood cultures

  2. Collapsibility associated with failure

    Time frame: Baseline

    Percentage of vein collapsibility independently associated with cannulation failure

  3. Cannulation number of attempts

    Time frame: Baseline

    Number of attempts needed to attain cannulation

  4. Procedure time

    Time frame: Baseline

    Time from skin puncture to guidewire confirmed into vessel (minutes)

  5. Arterial puncture rate

    Time frame: Baseline

    Confirmed immediately after procedure with vascular ultrasound

  6. Hematoma formation rate

    Time frame: 7 days

    Confirmed immediately after procedure with vascular ultrasound

  7. Neumothorax rate

    Time frame: 7 days

    Confirmed immediately after procedure with lung ultrasound

  8. Hemothorax rate

    Time frame: 7 days

    Confirmed immediately after procedure with lung ultrasound

Study contacts

Contact information is provided by the study sponsor or research team.

Guadalupe Aguirre-Avalos, MD

CONTACT

Miguel Ibarra-Estrada, MD

CONTACT

[email protected]

3317593502

Sponsors and collaborators

Lead sponsor

Hospital Civil de Guadalajara

Other

Collaborators

  • Instituto Jalisciense de Cancerologia

Registry information

Official study title

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

Acronym: INVADE

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Feb 11, 2020
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.