Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2026-01-03 @ 2:32 AM
Study NCT ID:
NCT03523533
Status:
TERMINATED
Last Update Posted:
2024-03-12
First Post:
2018-05-01
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Peripherally Inserted Internal Jugular Catheters: an Observational Study
Sponsor:
University of New Mexico
Organization:
Study Overview
Official Title:
Peripherally Inserted Internal Jugular Catheters: an Observational Study
Status:
TERMINATED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Investigator Decision \& not a clinical trial.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: