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

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

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

Study Overview

• Status: Recruiting
• Conditions: Critical Illness
• Intervention / Treatment: Procedure: Internal jugular vein catheterization; Procedure: Subclavian vein catheterization; Procedure: Innominate vein catheterization

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.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Miguel Ibarra-Estrada, MD; Phone Number: 3317593502; Email: drmiguelibarra@hotmail.com
• Study Contact Backup: Name: Guadalupe Aguirre-Avalos, MD

Study Locations

• Mexico
  • Guadalajara, Mexico, 44280
    • Recruiting
    • Hospital Civil Fray Antonio Alcalde
    • Contact: Miguel Ibarra-Estrada, MD; Phone Number: 3317593502; Email: drmiguelibarra@hotmail.com
    • Contact: Guadalupe Aguirre-Avalos, MD; Email: guadalupe.aavalos@academicos.udg.mx
    • Sub-Investigator: Quetzalcóatl Chávez-Peña, MD
    • Sub-Investigator: Arnulfo López-Pulgarín, MD
    • Principal Investigator: Miguel Ibarra-Estrada, MD
    • Sub-Investigator: Guadalupe Aguirre-Avalos, MD
    • Sub-Investigator: Pável Aguilera-González, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Internal jugular vein site; Ultrasound-guided central venous catheterization at internal jugular vein site	Procedure: Internal jugular vein catheterization; Catheterization of internal jugular vein with real-time (in-plane) method, with neutral neck position. Standard aseptic technique.
Active Comparator: Subclavian vein site; Ultrasound-guided central venous catheterization at subclavian vein site	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.
Active Comparator: Innominate vein site; Ultrasound-guided central venous catheterization at innominate vein site	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cannulation failure rate	Failure to cannulate selected vein after three attempts	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Collapsibility associated with failure	Percentage of vein collapsibility independently associated with cannulation failure	Baseline
Cannulation number of attempts	Number of attempts needed to attain cannulation	Baseline
Procedure time	Time from skin puncture to guidewire confirmed into vessel (minutes)	Baseline
Arterial puncture rate	Confirmed immediately after procedure with vascular ultrasound	Baseline
Hematoma formation rate	Confirmed immediately after procedure with vascular ultrasound	7 days
Neumothorax rate	Confirmed immediately after procedure with lung ultrasound	7 days
Hemothorax rate	Confirmed immediately after procedure with lung ultrasound	7 days
Central line-associated blood infection rate	Confirmed with blood cultures	28 days

Collaborators and Investigators

• Sponsor: Hospital Civil de Guadalajara
• Collaborators: Instituto Jalisciense de Cancerologia
• Investigators: Principal Investigator: Miguel Ibarra-Estrada, MD, Hospital Civil Fray Antonio Alcalde

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2019
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: February 9, 2020
• First Submitted That Met QC Criteria: February 9, 2020
• First Posted (Actual): February 11, 2020

Study Record Updates

• Last Update Posted (Estimated): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Brachiocephalic vein; Central venous access; Ultrasound-guided catheterization; Innominate vein
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: HCG/CEI-1196/19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No