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

Not Applicable

Recruiting

• Conditions: Critical Illness
• Interventions: Procedure: Internal jugular vein catheterization; Procedure: Innominate vein catheterization; Procedure: Subclavian vein catheterization

• Registration Number: NCT04265703
• Lead Sponsor: Hospital Civil de Guadalajara

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.

Study Timeline

• Study Start: 2019-10-12
• Study First Submitted: 2020-02-09
• Study First Submitted QC: 2020-02-09
• Study First Posted: 2020-02-11
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-05
• Last Update Posted: 2024-05-07
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Internal jugular vein site	Internal jugular vein catheterization	Ultrasound-guided central venous catheterization at internal jugular vein site
Innominate vein site	Innominate vein catheterization	Ultrasound-guided central venous catheterization at innominate vein site
Subclavian vein site	Subclavian vein catheterization	Ultrasound-guided central venous catheterization at subclavian vein site

Primary Outcome Measures

Name	Time	Method
Cannulation failure rate	Baseline	Failure to cannulate selected vein at first attempt

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital Civil Fray Antonio Alcalde; 🇲🇽 Guadalajara, Mexico