Clinical trial NCT01966354: Comparison of Three Techniques for Ultrasound-guided Internal Jugular Cannulation
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ultrasound-guided Internal Jugular Cannulation
Central Venous Access Complications
Keywords: adult
catheterization, central venous
ultrasonography, interventional
evidence-based medicine
cost-benefit analysis
Lead sponsor: Fundacion Miguel Servet
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
First posted: 2013-10-21
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Cannulation Success
timeFrame: At the end of the cannulation process (180 seconds, maximum)
Secondary outcomes:
measure: Number of Cannulation Attempts
timeFrame: At the end of the cannulation process (180 seconds, maximum)
measure: First Attempt Cannulation
timeFrame: At the end of the cannulation process (180 seconds, maximum)
measure: Cannulation Time
timeFrame: At the end of the cannulation process (180 seconds, maximum)
measure: Mechanical Complications
timeFrame: At the end of the cannulation process (180 seconds, maximum)
measure: Infectious Complications
timeFrame: Once the central venous catheter is withdrawn (2 months)
Other outcomes:
Locations:
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Navarra, Anesthesiology department
state: Navarra
Study officials:
affiliation: Complejo Hospitalario de Navarra, Anesthesiology department
name: Mikel Batllori, MD
role: STUDY_DIRECTOR
References:
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