Clinical trial NCT03523533: Peripherally Inserted Internal Jugular Catheters: an Observational Study
Official title: Peripherally Inserted Internal Jugular Catheters: an Observational Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Intravenous Drug Usage
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2018-05-14
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is an observational study.
Primary purpose: OTHER

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.

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.

Eligibility 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

Primary outcomes:
measure: Catheter Placement Time
timeFrame: No more than 20 minutes
Secondary outcomes:
measure: Location of Insertion
timeFrame: No more than 20 minutes
measure: Depth of Insertion
timeFrame: No more than 20 minutes
measure: Number of Attempts
timeFrame: No more than 20 minutes
measure: Number of Participants Experiencing Catheter-related Complications
timeFrame: 1 week
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico Hospital
state: New Mexico
Study officials:
affiliation: University of New Mexico Health Sciences Center (HSC)
name: Tony Yen, MD
role: PRINCIPAL_INVESTIGATOR
References: