Peripherally Inserted Central Catheter Clinical Trial
Official title:
A Prospective, Randomized Study Comparing Device Performance Characteristics and Safety of Arrow Peripherally Inserted Central Catheters With Arrowga+rd Blue Advanced Protection to Standard Unprotected PICCs
NCT number | NCT05278507 |
Other study ID # | 2018-10 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | January 16, 2020 |
Est. completion date | June 30, 2023 |
Verified date | March 2022 |
Source | Teleflex |
Contact | Linda Wu |
Phone | 15010697631 |
lindi.wu[@]teleflex.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study seeks to compare the standard unprotected PICC with the AGBA PICC for placement success, incidence of venous thrombosis through duplex ultrasound, observing for signs and symptoms of thrombotic occlusion and recording treatment response when diagnosed by sluggish fluid flow, inability to aspirate blood and or difficulty/inability to infuse via a lumen or lumens of the catheter. The incidence of catheter-related bloodstream infection will also be tracked during the study.
Status | Recruiting |
Enrollment | 444 |
Est. completion date | June 30, 2023 |
Est. primary completion date | June 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients age = 18 years requiring a PICC - Patient will remain an inpatient for the entire dwell time - Ability to comply with study requirements of duplex ultrasound procedures prior to and at the time of PICC removal - Patients cognitively and physically able to give written consent to participate in the study or patient has a legally authorized representative (LAR) who may give written consent to participate in the study Exclusion Criteria: - Current diagnosis of venous thrombosis within the venous tract of the proposed catheter - Diagnosis of peripheral or central vein stenosis (on proposed insertion side) - History or diagnosis of veno-occlusive disease - Diagnosis of superior vena cava syndrome - Known, pre-existing diagnosis of hypercoagulation disorder unrelated to underlying disease - Previous enrollment in this study - Currently pregnant or breast feeding - Skin condition at or within 15 cm of the proposed catheter insertion site, including signs and symptoms of inflammation, rash, crusts, wounds with drainage, sites of intravenous infusion infiltration or extravasation, hematoma, phlebitis and or thrombophlebitis - Medical, social, and/or psychological problems precluding subject from study participation - Known allergy or sensitivity to chlorhexidine |
Country | Name | City | State |
---|---|---|---|
China | Beijing Hospital | Beijing | Doncheng District |
China | Peking University People's Hospital | Beijing | Xicheng District |
China | Peking University Third Hospital | Beijing | Haidian District |
China | The Fifth Medical Center of Chinese PLA General Hospital | Beijing | Fengtai District |
China | The First Medical Center of Chinese PLA General Hospital | Beijing | Haidian District |
Lead Sponsor | Collaborator |
---|---|
Teleflex |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | First attempt PICC insertion success | rate of first attempt insertion success = number of patients with first attempt insertion /total number of patients *100% • First attempt insertion success and number of failed attempts will be documented |
During placement | |
Primary | PICC Placement Success - Confirmation of tip placement in the lower 1/3 of the superior vena cava at or above the superior vena cava/right atrium junction will be performed by chest x-ray or other tip confirmation system/device and documented. | Once the PICC placement is complete, confirmation of catheter tip location in the lower 1/3 of the superior vena cava at or above the superior vena cava/right atrium junction will be performed by chest x-ray or other tip confirmation system/device and documented. Any adjustments to catheter length post-insertion must be performed using sterile technique and maximal barrier precautions. The number of adjustments to the inserted PICC needed to achieve proper tip location will be recorded. | During placement | |
Primary | Confirmation of tip patency by aspirating each lumen for brisk blood return and flushing each lumen with at least 10 mL of 0.9% NaCl injection USP | Once the PICC placement is complete, the inserter will confirm patency by aspirating each lumen for brisk blood return and flushing each lumen with at least 10 mL of 0.9% NaCl injection USP. For inpatients, each lumen will be assessed for patency at least every 12 hours and/or before administration of infusion therapies. Patency assessments will be documented. Patency checks resulting in brisk blood return and ability to flush easily will be considered patent. Patency checks resulting in inability to aspirate blood with ability to flush easily will be documented as a withdrawal occlusion. Patency checks resulting in sluggish flow and/or ability to flush will be documented as a partial occlusion. Patency checks resulting in inability to aspirate blood and inability to flush will be documented as a complete occlusion. |
up to 92 days | |
Primary | Incidence of catheter related bloodstream infection assessed by laboratory confirmed bloodstream infection | Subjects will be assessed for laboratory confirmed bloodstream infection (LCBI) as described below through one day post PICC removal LCBI 1 Patient of any age has a recognized pathogen, which is an organism not included on the NHSN common commensal list, identified from one or more blood specimens obtained by a culture or non-culture based microbiologic testing method (excluding organisms identified by testing on sera) AND Organism(s) identified in blood is not related to an infection at another site LCBI 2 Patient of any age has at least one of the following signs or symptoms: fever (>38.0oC), chills, or hypotension AND Organism(s) identified in blood is not related to an infection at another site AND The same NHSN common commensal is identified by a culture or non-culture based microbiologic testing method, from two or more blood specimens collected on separate occasions. |
up to 92 days | |
Secondary | Incidence of complete loss of catheter function versus the total number of effective catheters placed | Incidence of total loss of catheter function = number of total loss of catheter function/number of effective catheter placement | up to 92 days | |
Secondary | Incidence of catheter-associated external wall thrombosis versus the total number of effective catheters placed | Incidence of catheter-related external wall thrombosis = number of patients with catheter-related external wall thrombosis/total number of patients with effective catheter placement | up to 92 days | |
Secondary | Device performance evaluation | Evaluate whether the accessories in the package meet the control requirements of the country and the medical institution, whether the guide wire placement is smooth, whether the catheter placement is smooth, and whether the product is smooth and satisfactory | During placement | |
Secondary | Evaluation of other safety parameters such as Adverse Events and Device Defects during testing | Vital signs (temperature (C), heart rate (b.p.m.), respiration rate (b.p.m.) and blood pressure (m.m.Hg) throughout the clinical study period); Laboratory examination (as appropriate during the evaluation process); The number and incidence of any related adverse events, severe adverse events during the trial Number and incidence of any device defects during the test |
up to 92 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
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