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Peripherally Inserted Internal Jugular Catheters: an Observational Study

Peripherally Inserted Internal Jugular Catheters: an Observational Study

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03523533
Enrollment
5
Registered
2018-05-14
Start date
2018-08-03
Completion date
2018-11-21
Last updated
2024-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intravenous Drug Usage

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.

Interventions

PROCEDUREAngiocatheter

Placement of angiocatheter in internal jugular vein

Sponsors

University of New Mexico
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Intervention model description

This is an observational study.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Catheter Placement TimeNo more than 20 minutesElapsed time from first contact of skin prep solution to completely secured/covered catheter

Secondary

MeasureTime frameDescription
Location of InsertionNo more than 20 minutesChoice of placement on patient's right or left side
Depth of InsertionNo more than 20 minutesDepth of catheter insertion in target blood vessel
Number of AttemptsNo more than 20 minutesCount of attempts to successfully place catheter
Number of Participants Experiencing Catheter-related Complications1 weekCount of subjects experiencing complications that are related to catheter placement

Countries

United States

Participant flow

Participants by arm

ArmCount
Peripherally-inserted Internal Jugular Catheter
All enrolled patients will receive a peripheral angiocatheter in the internal jugular vein, under dynamic ultrasound guidance. Angiocatheter: Placement of angiocatheter in internal jugular vein
5
Total5

Baseline characteristics

CharacteristicPeripherally-inserted Internal Jugular Catheter
Age, Continuous48 years
STANDARD_DEVIATION 18
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
0 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
5 Participants
Race (NIH/OMB)
White
0 Participants
Sex: Female, Male
Female
3 Participants
Sex: Female, Male
Male
2 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 5
other
Total, other adverse events
2 / 5
serious
Total, serious adverse events
0 / 5

Outcome results

Primary

Catheter Placement Time

Elapsed time from first contact of skin prep solution to completely secured/covered catheter

Time frame: No more than 20 minutes

ArmMeasureValue (MEAN)Dispersion
Peripherally-inserted Internal Jugular CatheterCatheter Placement Time5.06 minutesStandard Deviation 0.78
Secondary

Depth of Insertion

Depth of catheter insertion in target blood vessel

Time frame: No more than 20 minutes

ArmMeasureValue (MEAN)Dispersion
Peripherally-inserted Internal Jugular CatheterDepth of Insertion3.4 centimetersStandard Deviation 1.2
Secondary

Location of Insertion

Choice of placement on patient's right or left side

Time frame: No more than 20 minutes

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Peripherally-inserted Internal Jugular CatheterLocation of InsertionCatheter placed on patient's right side5 Participants
Peripherally-inserted Internal Jugular CatheterLocation of InsertionCatheter placed on patient's left side0 Participants
Secondary

Number of Attempts

Count of attempts to successfully place catheter

Time frame: No more than 20 minutes

ArmMeasureValue (MEAN)
Peripherally-inserted Internal Jugular CatheterNumber of Attempts1 Attempt
Secondary

Number of Participants Experiencing Catheter-related Complications

Count of subjects experiencing complications that are related to catheter placement

Time frame: 1 week

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Peripherally-inserted Internal Jugular CatheterNumber of Participants Experiencing Catheter-related ComplicationsPatients experiencing carotid puncture0 Participants
Peripherally-inserted Internal Jugular CatheterNumber of Participants Experiencing Catheter-related ComplicationsPatients experiencing pneumothorax0 Participants
Peripherally-inserted Internal Jugular CatheterNumber of Participants Experiencing Catheter-related ComplicationsPatients experiencing thrombosis0 Participants
Peripherally-inserted Internal Jugular CatheterNumber of Participants Experiencing Catheter-related ComplicationsPatients experiencing unexpectedly severe pain on placement0 Participants
Peripherally-inserted Internal Jugular CatheterNumber of Participants Experiencing Catheter-related ComplicationsPatients experiencing hematoma0 Participants
Peripherally-inserted Internal Jugular CatheterNumber of Participants Experiencing Catheter-related ComplicationsPatients experiencing injection-site infection0 Participants
Peripherally-inserted Internal Jugular CatheterNumber of Participants Experiencing Catheter-related ComplicationsPatients experiencing none of these complications5 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026