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Investigator Decision & not a clinical trial.
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peripherally-inserted internal jugular catheter | Experimental | All enrolled patients will receive a peripheral angiocatheter in the internal jugular vein, under dynamic ultrasound guidance. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Angiocatheter | Procedure | Placement of angiocatheter in internal jugular vein |
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| Measure | Description | Time Frame |
|---|---|---|
| Catheter Placement Time | Elapsed time from first contact of skin prep solution to completely secured/covered catheter | No more than 20 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Location of Insertion | Choice of placement on patient's right or left side | No more than 20 minutes |
| Depth of Insertion | Depth of catheter insertion in target blood vessel |
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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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tony Yen, MD | University of New Mexico Health Sciences Center (HSC) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of New Mexico Hospital | Albuquerque | New Mexico | 87106 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Catheter Placement Time | Elapsed time from first contact of skin prep solution to completely secured/covered catheter | Posted | Mean | Standard Deviation | minutes | No more than 20 minutes |
|
|
One week
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Loss of Catheter Patency | Product Issues | Systematic Assessment | Loss of patency (open catheter allowing appropriate fluid flow) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Tim Petersen | University of New Mexico Health Sciences Center (HSC) | 5052722610 | timpetersen@salud.unm.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 20, 2018 | Aug 25, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 20, 2018 | Aug 25, 2022 | ICF_001.pdf |
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This is an observational study.
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| No more than 20 minutes |
| Number of Attempts | Count of attempts to successfully place catheter | No more than 20 minutes |
| Number of Participants Experiencing Catheter-related Complications | Count of subjects experiencing complications that are related to catheter placement | 1 week |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Secondary | Location of Insertion | Choice of placement on patient's right or left side | Posted | Count of Participants | Participants | No more than 20 minutes |
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|
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| Secondary | Depth of Insertion | Depth of catheter insertion in target blood vessel | Posted | Mean | Standard Deviation | centimeters | No more than 20 minutes |
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|
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| Secondary | Number of Attempts | Count of attempts to successfully place catheter | Posted | Mean | Full Range | Attempt | No more than 20 minutes |
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|
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| Secondary | Number of Participants Experiencing Catheter-related Complications | Count of subjects experiencing complications that are related to catheter placement | Posted | Count of Participants | Participants | 1 week |
|
|
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| 0 |
| 5 |
| 0 |
| 5 |
| 2 |
| 5 |
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| Patients experiencing unexpectedly severe pain on placement |
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| Patients experiencing hematoma |
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| Patients experiencing injection-site infection |
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| Patients experiencing none of these complications |
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