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Peripherally Inserted Internal Jugular Catheters: an Observational Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03523533
Recruitment Status : Recruiting
First Posted : May 14, 2018
Last Update Posted : September 30, 2019
Sponsor:
Information provided by (Responsible Party):
Tony Yen, University of New Mexico

Brief Summary:
This is an observational study intended to characterize the time-to-placement of peripherally-inserted internal jugular (PIJ) catheters in appropriate patients. As secondary outcomes and to ensure patient safety, the investigators will record and evaluate adverse outcomes, but the study is not powered to detect rare events.

Condition or disease Intervention/treatment Phase
Intravenous Drug Usage Procedure: Angiocatheter Not Applicable

Detailed Description:

This is an observational study with one arm. All enrolled patients will receive a peripheral angiocatheter in the internal jugular vein. Approximately 60 subjects will be enrolled.

After recruitment and consent, an investigator will place the peripherally-inserted jugular (PIJ) catheters for this study, under ultrasound guidance. Clean technique similar to that used for traditional peripheral intravenous catheters will be used, including chlorhexidine skin preparation, caps, and sterile ultrasound gel with sterile occlusive dressing over the ultrasound transducer. For patients included in this study because of a clinically-determined need for a second IV line, the catheter will be placed after anesthesia induction. Patients included because of difficult IV access will have the PIJ catheter placed prior to induction.

The size of the angiocatheter will be left to the clinical discretion of the investigator, from among these choices: 18G x 2.5 inches, 16G x 2 inches, or 14G x 2 inches. All angiocatheters will be radiopaque in order to permit visualization in the event of any required imaging. Catheters will be placed with visualization under dynamic ultrasonography using a Sonosite S-Nerve ultrasound machine with 13-6 MHz 25 mm linear array. All catheters and ultrasound components are being used in accordance with their labeling.

The depth of catheter insertion into the internal jugular vein will be determined, and the catheter will be removed/replaced immediately if it is found to extend less than 1.0 cm into the vessel. If the catheter is removed or replaced, routine care will be followed: pressure will be held until bleeding subsides and the site dressed appropriately (e.g. gauze with tape or adhesive bandage). No more than three attempts will be made before abandoning the effort to place a PIJ catheter.

The PIJ catheter will be secured as per normal practice, with an adhesive IV securing device and an occlusive bandage placed over both the IV and its securing device.

The PIJ catheter will be used as usual during surgery. It will not be used for total parenteral nutrition or other continuous nutrient infusions.

In most cases, the PIJ catheter will be removed as usual before the patient is transferred to the floor, intensive care unit, or discharged home. In some cases, however, an appropriately authorized clinician may determine that the PIJ catheter should remain in place longer. If extended use of the PIJ catheter is indicated, it will be removed when it is either replaced as appropriate by another intravenous line or no longer needed.

Procedural data will be gathered on the day of surgery, and chart review will occur after surgery in order to capture any IV-related complications within the first week that were not immediately apparent.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: This is an observational study.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Peripherally Inserted Internal Jugular Catheters: an Observational Study
Actual Study Start Date : August 3, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
Experimental: Peripherally-inserted internal jugular catheter
All enrolled patients will receive a peripheral angiocatheter in the internal jugular vein, under dynamic ultrasound guidance.
Procedure: Angiocatheter
Placement of angiocatheter in internal jugular vein




Primary Outcome Measures :
  1. Catheter placement time [ Time Frame: No more than 20 minutes ]
    Elapsed time from first contact of skin prep solution to completely secured/covered catheter


Secondary Outcome Measures :
  1. Location of insertion [ Time Frame: No more than 20 minutes ]
    Choice of placement on patient's right or left side

  2. Depth of insertion [ Time Frame: No more than 20 minutes ]
    Depth of catheter insertion in target blood vessel

  3. Number of attempts [ Time Frame: No more than 20 minutes ]
    Count of attempts to successfully place catheter

  4. Incidence of complications [ Time Frame: 1 week ]
    Count of complications that are related to catheter placement



Information from the National Library of Medicine

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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: Adult elective-surgery patients at University of New Mexico Hospital main operating rooms, who do not require central venous catheters, and who either:

  1. require a second intravenous access line (IV) as determined by the anesthesiologist, *or*
  2. require a primary IV *and* are determined by the anesthesiologist to have difficult IV access, defined as two or more failed attempts at peripheral IV placement, in the absence of an indication for a central venous catheter.

Exclusion Criteria:

  • Infection over the intended peripheral angiocatheter insertion site
  • Cervical spine injury or instability
  • Known abnormal neck anatomy
  • Pregnancy
  • Prisoners
  • Clinical indication for central venous catheter
  • Any pre-existing suspicion for bacteremia
  • Adults unable to consent, as determined by ability to provide consent for surgery

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): NCT03523533


Contacts
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Contact: Tony Yen, MD 5052722610 tyen@salud.unm.edu
Contact: Timothy Petersen, PhD 5052722610 timpetersen@salud.unm.edu

Locations
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United States, New Mexico
University of New Mexico Hospital Recruiting
Albuquerque, New Mexico, United States, 87106
Contact: Tony Yen, MD    505-272-2610      
Sponsors and Collaborators
University of New Mexico
Investigators
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Principal Investigator: Tony Yen, MD University of New Mexico Health Sciences Center (HSC)
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Responsible Party: Tony Yen, Associate Professor, University of New Mexico
ClinicalTrials.gov Identifier: NCT03523533    
Other Study ID Numbers: 18-116
First Posted: May 14, 2018    Key Record Dates
Last Update Posted: September 30, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No