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Comparison of Three Techniques for Ultrasound-guided Internal Jugular Cannulation (OISO-1)

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ClinicalTrials.gov Identifier: NCT01966354
Recruitment Status : Completed
First Posted : October 21, 2013
Results First Posted : June 28, 2016
Last Update Posted : August 1, 2016
Sponsor:
Collaborator:
Instituto de Salud Carlos III
Information provided by (Responsible Party):
Mikel Batllori, Fundacion Miguel Servet

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.

Condition or disease Intervention/treatment Phase
Ultrasound-guided Internal Jugular Cannulation Central Venous Access Complications Procedure: Ultrasound-guided Internal jugular venous approach Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
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 Start Date : March 2012
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Experimental: Long axis, in-plane needle

Ultrasound-guided Internal jugular venous approach

Long axis, in-plane needle:

Jugular vein is ultrasonographically visualized in a longitudinal fashion (long axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.

Procedure: Ultrasound-guided Internal jugular venous approach

The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.

In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane).


Experimental: Short axis, out-of-plane needle

Ultrasound-guided Internal jugular venous approach

Short axis, out-of-plane needle:

Jugular vein is ultrasonographically visualized in a transverse fashion (short axis) and the needle is inserted perpendicular to the longitudinal axis of the transducer (out-of-plane).

Procedure: Ultrasound-guided Internal jugular venous approach

The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.

In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane).


Experimental: Oblique axis, in-plane needle

Ultrasound-guided Internal jugular venous approach

Oblique axis, in-plane needle:

Jugular vein is ultrasonographically visualized in an oblique axis (intermediate view between long and short axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.

Procedure: Ultrasound-guided Internal jugular venous approach

The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.

In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane).





Primary Outcome Measures :
  1. Cannulation Success [ Time Frame: 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 :
  1. Number of Cannulation Attempts [ Time Frame: 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.

  2. First Attempt Cannulation [ Time Frame: 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.

  3. Cannulation Time [ Time Frame: 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.

  4. Mechanical Complications [ Time Frame: 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.

  5. Infectious Complications [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01966354


Locations
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Spain
Complejo Hospitalario de Navarra, Anesthesiology department
Pamplona, Navarra, Spain, 31008
Sponsors and Collaborators
Mikel Batllori
Instituto de Salud Carlos III
Investigators
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Study Director: Mikel Batllori, MD Complejo Hospitalario de Navarra, Anesthesiology department

Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mikel Batllori, Mikel Batllori Gaston, MD, Fundacion Miguel Servet
ClinicalTrials.gov Identifier: NCT01966354     History of Changes
Other Study ID Numbers: PI12/00679
First Posted: October 21, 2013    Key Record Dates
Results First Posted: June 28, 2016
Last Update Posted: August 1, 2016
Last Verified: June 2016

Keywords provided by Mikel Batllori, Fundacion Miguel Servet:
adult
catheterization, central venous
ultrasonography, interventional
evidence-based medicine
cost-benefit analysis