Central Venous Access Complications Clinical Trial
— OISO-1Official title:
Comparison of Three Techniques for Ultrasound-guided Internal Jugular Cannulation: Long Axis, In-plane Needle v. Short Axis, Out-of-plane Needle v. Oblique Axis, In-plane Needle
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.
| Status | Completed |
| Enrollment | 220 |
| Est. completion date | March 2013 |
| Est. primary completion date | March 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Spain | Complejo Hospitalario de Navarra, Anesthesiology department | Pamplona | Navarra |
| Lead Sponsor | Collaborator |
|---|---|
| Mikel Batllori | Instituto de Salud Carlos III |
Spain,
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* Note: There are 13 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Cannulation success | 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. | At the end of the cannulation process (180 seconds, maximum) | No |
| Secondary | Number of cannulation attempts | 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. | At the end of the cannulation process (180 seconds, maximum) | No |
| Secondary | First attempt cannulation | 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. | At the end of the cannulation process (180 seconds, maximum) | No |
| Secondary | Cannulation time | 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. | At the end of the cannulation process (180 seconds, maximum) | No |
| Secondary | Mechanical complications | The incidence of the following mechanical complications will be registered: arterial puncture, puncture site bleeding, puncture site haematoma, pneumothorax, 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. | At the end of the cannulation process (180 seconds, maximum) | Yes |
| Secondary | Infectious complications | 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 | Once the central venous catheter is withdrawn (2 months) | Yes |