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

NCT ID: NCT04265703

Last Updated: 2025-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 308 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-12
• Study Completion Date: 2025-09-15

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.

Conditions

Critical Illness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Internal jugular vein site

Ultrasound-guided central venous catheterization at internal jugular vein site

Group Type: ACTIVE_COMPARATOR

Internal jugular vein catheterization

Intervention Type: PROCEDURE

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

Subclavian vein site

Ultrasound-guided central venous catheterization at subclavian vein site

Group Type: ACTIVE_COMPARATOR

Subclavian vein catheterization

Intervention Type: PROCEDURE

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

Innominate vein site

Ultrasound-guided central venous catheterization at innominate vein site

Group Type: ACTIVE_COMPARATOR

Innominate vein catheterization

Intervention Type: 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.

Interventions

Internal jugular vein catheterization

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

Intervention Type: PROCEDURE

Subclavian vein catheterization

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

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto Jalisciense de Cancerologia

OTHER_GOV

Sponsor Role: collaborator

Hospital Civil de Guadalajara

OTHER

Sponsor Role: lead

Responsible Party

Miguel Á Ibarra-Estrada

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Miguel Ibarra-Estrada, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Civil Fray Antonio Alcalde

Locations

Hospital Civil Fray Antonio Alcalde

Guadalajara, , Mexico

Countries

Mexico

Other Identifiers

HCG/CEI-1196/19

Identifier Type: -

Identifier Source: org_study_id