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Clinical Trials/NCT01966354
NCT01966354CompletedNot Applicable

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

Mikel Batllori2 sites in 1 country220 target enrollmentStarted: March 1, 2012Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
220
Locations
2
Primary Endpoint
Cannulation Success
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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 Outcomes

  • Infectious Complications(Once the central venous catheter is withdrawn (2 months))
  • Number of Cannulation Attempts(At the end of the cannulation process (180 seconds, maximum))
  • Cannulation Time(At the end of the cannulation process (180 seconds, maximum))
  • Mechanical Complications(At the end of the cannulation process (180 seconds, maximum))
  • First Attempt Cannulation(At the end of the cannulation process (180 seconds, maximum))

Investigators

Sponsor
Mikel Batllori
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Mikel Batllori

Mikel Batllori Gaston, MD

Fundacion Miguel Servet

Study Sites (2)

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