Comparison of Three Techniques for Ultrasound-guided Internal Jugular Cannulation
- Conditions
- Ultrasound-guided Internal Jugular CannulationCentral Venous Access Complications
- Registration Number
- NCT01966354
- Lead Sponsor
- Mikel Batllori
- Brief Summary
The purpose of this study is to assess the efficacy and safety of three ultrasound assistance techniques for internal jugular venous cannulation, in terms of cannulation success and prevention of complications.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 220
- Patients aged 18 or older
- Indication for internal jugular venous cannulation, previously established by the doctor responsible for the patient´s hospital diagnosis and treatment
- Informed consent for trial participation has been obtained from the patient
- Infection signs at or close to puncture site
- Cutaneous erosions or subcutaneous haematoma at or close to puncture site
- History of internal jugular venous cannulation during the past 72 hours (in the same side in which the present cannulation is taking place)
- History of previous surgical interventions on the cannulation site
- Recent cervical trauma with present neck immobilization and without having ruled out eventual cervical spinal injury
- Severe coagulopathy (altered coagulation parameters and active bleeding) which cannot be promptly corrected by platelet, fresh frozen plasma or pharmacologic intervention
- Subcutaneous emphysema with cervical extension
- Agitated or uncooperative patient (including deep sedation)
- Inability to obtain formal informed consent from the patient or his legally authorized representative (in case the patient is legally incompetent to give informed consent)
- Cannulation being performed outside the surgical area or the post-anesthesia care unit
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Cannulation Success At the end of the cannulation process (180 seconds, maximum) Cannulation will be considered as "successful" once a flexible guidewire has been inserted into the internal jugular vein during the first 180 seconds from the moment the Seldinger needle pierces the skin. If time spent until guidewire insertion is more than 180 seconds, or if guidewire cannot be inserted into the internal jugular vein chosen, cannulation will be considered "unsuccessful". This outcome measure will be registered at the end of the cannulation process.
- Secondary Outcome Measures
Name Time Method Infectious Complications Once the central venous catheter is withdrawn (2 months) The incidence of bacterial catheter colonization and catheter-related blood stream infection will be registered once the central venous catheter has been withdrawn. Patients will be followed for the duration of central venous access, an expected average of 8 weeks. The number of patients with bacterial colonization and catheter-related blood stream infection will be registered.
Number of Cannulation Attempts At the end of the cannulation process (180 seconds, maximum) Number of cannulation attempts that have taken place before cannulation success. Any withdrawal of the needle followed by an advance will be considered a separated cannulation attempt.This outcome measure will be registered at the end of the cannulation process.
Cannulation Time At the end of the cannulation process (180 seconds, maximum) Time elapsed (seconds) from the moment the Seldinger needle pierces the skin to the moment the guidewire is inserted inside the vein. This outcome measure will be registered at the end of the cannulation process.
Mechanical Complications At the end of the cannulation process (180 seconds, maximum) The incidence of the following mechanical complications will be registered: number of patients with accidental arterial puncture, number of patients with puncture site bleeding, number of patients with puncture site haematoma, number of patients with pneumothorax, number of patients catheter tip misplacement. This outcome measure will be registered at the end of the cannulation process, and once a control chest x-Ray has been performed.
First Attempt Cannulation At the end of the cannulation process (180 seconds, maximum) Any cannulation that has been accomplished with a single cannulation attempt will be considered a "first attempt cannulation". This outcome measure will be registered at the end of the cannulation process.
Trial Locations
- Locations (1)
Complejo Hospitalario de Navarra, Anesthesiology department
🇪🇸Pamplona, Navarra, Spain
Complejo Hospitalario de Navarra, Anesthesiology department🇪🇸Pamplona, Navarra, Spain