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The goal of this study is to determine whether Peripherally Inserted Central Catheter or Centrally Inserted Venous Catheters have lower complication rates in the Neuroscience Intensive Care Unit. After admission to the Neuroscience ICU and if they require central access, patients will be randomized to receive a PICC or CVC and complications (such as pneumothorax, deep venous thrombosis, infection, etc.) will be tracked and compared between the two interventions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PICC | Active Comparator | Patients randomly assigned to receive a peripherally inserted central catheter and they will be monitored for either having a complication or no complication. |
|
| CVC | Active Comparator | Patients randomly assigned to receive a centrally inserted central catheter and they will be monitored for either having a complication or no complication. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| peripherally inserted central catheter | Device | Any complication associated with central access |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Participants With Complications With Central Access Including Insertion | Aggregation of all complications associated with central access including insertion | up to 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Deep Venous Thrombosis | up to 10 weeks | |
| Number of Patients With Complications Related to Insertion | Any complication of insertion including technical failure | From the time of insertion until first confirmatory chest X-ray |
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Inclusion Criteria:
Adult patients admitted to the NSICU, who require central access for the treatment of their illness.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | PICC | Patients randomly assigned to receive a peripherally inserted central catheter and they will be monitored for either having a complication or no complication. peripherally inserted central catheter: Any complication associated with central access |
| FG001 | Central Line | Patients randomly assigned to receive a centrally inserted central catheter and they will be monitored for either having a complication or no complication. centrally inserted central catheter: Central access not associated with any complication |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PICC | Patients randomly assigned to receive a peripherally inserted central catheter and they will be monitored for either having a complication or no complication. peripherally inserted central catheter: Any complication associated with central access |
| BG001 | Central Line |
| 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 | Participants With Complications With Central Access Including Insertion | Aggregation of all complications associated with central access including insertion | Posted | Count of Participants | Participants | up to 10 weeks |
|
19 Months
Definitions do not differ.
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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 | PICC | Patients randomly assigned to receive a peripherally inserted central catheter and they will be monitored for either having a complication or no complication. peripherally inserted central catheter: Any complication associated with central access |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Deep venous thrombosis | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. J. Christopher Zacko | Penn State Health Milton S. Hershey Medical Center Dept of Neurosurgery | 717-531-1279 | jzacko@pennstatehealth.psu.edu |
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| ID | Term |
|---|---|
| D002406 | Catheterization, Peripheral |
| ID | Term |
|---|---|
| D002404 | Catheterization |
| D013812 | Therapeutics |
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
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| centrally inserted central catheter |
| Device |
Central access not associated with any complication |
|
| Number of Participants With a Central Line Associated Blood Stream Infection | A Central access associated infection (CLABSI) | up to 10 weeks |
Patients randomly assigned to receive a centrally inserted central catheter and they will be monitored for either having a complication or no complication. centrally inserted central catheter: Central access not associated with any complication |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Glasgow Coma Scale (Total) | The Glasgow Goma Scale (GCS) gives a description of level of consciousness. Patients are assigned a minimum of 1 and maximum of 6 units on a scale for motor skills, a minimum of 1 and maximum of 5 units on a scale for verbal skills, a minimum of 1 and maximum of 4 units on a scale for eye opening function. The total GCS is a simple sum of all of the units on a scale with a minimum of 3 and maximum of 15. Higher values indicate higher neurologic function. | Median | Standard Deviation | points |
|
| Hemiparesis | Count of Participants | Participants |
|
| Diagnosis | Count of Participants | Participants |
|
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|
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| Secondary | Number of Participants With Deep Venous Thrombosis | Posted | Count of Participants | Participants | up to 10 weeks |
|
|
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| Secondary | Number of Patients With Complications Related to Insertion | Any complication of insertion including technical failure | Posted | Count of Participants | Participants | From the time of insertion until first confirmatory chest X-ray |
|
|
|
| Secondary | Number of Participants With a Central Line Associated Blood Stream Infection | A Central access associated infection (CLABSI) | Posted | Count of Participants | Participants | up to 10 weeks |
|
|
|
| 13 |
| 72 |
| 4 |
| 72 |
| 0 |
| 72 |
| EG001 | Central Line | Patients randomly assigned to receive a centrally inserted central catheter and they will be monitored for either having a complication or no complication. centrally inserted central catheter: Central access not associated with any complication | 9 | 80 | 1 | 80 | 0 | 80 |
| Pneumothorax | Injury, poisoning and procedural complications | Systematic Assessment |
|
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| D013504 |
| Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D008919 | Investigative Techniques |
| traumatic brain injury |
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| intraparenchymal hematoma |
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| myasthenia gravis |
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| intraventricular hemorrhage |
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| other |
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