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| Name | Class |
|---|---|
| Instituto Jalisciense de Cancerologia | OTHER_GOV |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Internal jugular vein site | Active Comparator | Ultrasound-guided central venous catheterization at internal jugular vein site |
|
| Subclavian vein site | Active Comparator | Ultrasound-guided central venous catheterization at subclavian vein site |
|
| Innominate vein site | Active Comparator | Ultrasound-guided central venous catheterization at innominate vein site |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Internal jugular vein catheterization | Procedure | Catheterization of internal jugular vein with real-time (in-plane) method, with neutral neck position. Standard aseptic technique. |
| Measure | Description | Time Frame |
|---|---|---|
| Cannulation failure rate | Failure to cannulate selected vein at first attempt | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Central line-associated blood infection rate | Confirmed with blood cultures | 28 days |
| Collapsibility associated with failure | Percentage of vein collapsibility independently associated with cannulation failure |
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Inclusion Criteria:
Exclusion Criteria:
Less than 18 years-old
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Miguel Ibarra-Estrada, MD | Contact | 3317593502 | drmiguelibarra@hotmail.com | |
| Guadalupe Aguirre-Avalos, MD | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Miguel Ibarra-Estrada, MD | Hospital Civil Fray Antonio Alcalde | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Civil Fray Antonio Alcalde | Recruiting | Guadalajara | 44280 | Mexico |
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| Subclavian vein catheterization | Procedure | Catheterization of subclavian/axillary vein with infra-clavicular approach with real-time (in-plane) method, without shoulder retraction. Standard aseptic technique. |
|
| Innominate vein catheterization | 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. |
|
| 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 |
| ID | Term |
|---|---|
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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