The INVADE Study: INnominate Vein Approach for Central Catheterization in Difficult to cannulatE Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Internal jugular vein catheterization, Subclavian vein catheterization, Innominate vein catheterization.
- Who it may be relevant to
- Registry conditions: Critical Illness. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Mexico
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Central Venous Access in Patients With Difficult Cannulation, A Randomized Controlled Trial
Overview
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.
Interventions
- Procedure Internal jugular vein catheterization
Catheterization of internal jugular vein with real-time (in-plane) method, with neutral neck position. Standard aseptic technique. - 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. - 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.
Primary outcome measures
- Cannulation failure rate [Time frame: Baseline]
Secondary outcome measures (8)
- Central line-associated blood infection rate [Time frame: 28 days]
- Collapsibility associated with failure [Time frame: Baseline]
- Cannulation number of attempts [Time frame: Baseline]
- Procedure time [Time frame: Baseline]
- Arterial puncture rate [Time frame: Baseline]
- Hematoma formation rate [Time frame: 7 days]
- Neumothorax rate [Time frame: 7 days]
- Hemothorax rate [Time frame: 7 days]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Mexico · 1 center
- Hospital Civil Fray Antonio Alcalde — Guadalajara
Identifiers
NCT: NCT04265703 · HCG/CEI-1196/19