Critical Illness
Conditions
Keywords
Central venous access, Ultrasound-guided catheterization, Innominate vein, Brachiocephalic vein
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.
Interventions
Catheterization of internal jugular vein with real-time (in-plane) method, with neutral neck position. Standard aseptic technique.
PROCEDURESubclavian vein catheterization
Catheterization of subclavian/axillary vein with infra-clavicular approach with real-time (in-plane) method, without shoulder retraction. Standard aseptic technique.
PROCEDUREInnominate 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.
Sponsors
Hospital Civil de Guadalajara
Instituto Jalisciense de Cancerologia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cannulation failure rate | Baseline | Failure to cannulate selected vein at first attempt |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Hematoma formation rate | 7 days | Confirmed immediately after procedure with vascular ultrasound |
| Neumothorax rate | 7 days | Confirmed immediately after procedure with lung ultrasound |
| Hemothorax rate | 7 days | Confirmed immediately after procedure with lung ultrasound |
Countries
Mexico
Contacts
CONTACTMiguel Ibarra-Estrada, MD
CONTACTGuadalupe Aguirre-Avalos, MD
PRINCIPAL_INVESTIGATORMiguel Ibarra-Estrada, MD
Hospital Civil Fray Antonio Alcalde
Outcome results
None listed