Central Line, Central Venous Catheter, CVC, Neuro ICU, Neuroscience ICU, PICC
Conditions
Brief summary
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.
Interventions
Any complication associated with central access
DEVICEcentrally inserted central catheter
Central access not associated with any complication
Sponsors
Milton S. Hershey Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adult patients admitted to the NSICU, who require central access for the treatment of their illness.
Exclusion criteria
1. Current or recent (within 1 month) diagnosis of bacteremia 2. Current or recent (within 1 year with confirmed resolution by imaging) deep venous thrombosis 3. Existing central access 4. Non-English speaking 5. Requirement for emergent central access and unable to obtain consent in an emergency setting
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants With Complications With Central Access Including Insertion | up to 10 weeks | Aggregation of all complications associated with central access including insertion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Deep Venous Thrombosis | up to 10 weeks | — |
| Number of Patients With Complications Related to Insertion | From the time of insertion until first confirmatory chest X-ray | Any complication of insertion including technical failure |
| Number of Participants With a Central Line Associated Blood Stream Infection | up to 10 weeks | A Central access associated infection (CLABSI) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 72 |
| 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 | 80 |
| Total | 152 |
Baseline characteristics
| Characteristic | PICC | Central Line | Total |
|---|---|---|---|
| Age, Continuous | 59.7 years STANDARD_DEVIATION 18 | 63.3 years STANDARD_DEVIATION 13.6 | 61.4 years STANDARD_DEVIATION 15.9 |
| Diagnosis intraparenchymal hematoma | 10 Participants | 12 Participants | 22 Participants |
| Diagnosis intraventricular hemorrhage | 0 Participants | 1 Participants | 1 Participants |
| Diagnosis myasthenia gravis | 0 Participants | 1 Participants | 1 Participants |
| Diagnosis other | 9 Participants | 11 Participants | 20 Participants |
| Diagnosis stroke | 28 Participants | 29 Participants | 57 Participants |
| Diagnosis subarachnoid hemorrhage | 14 Participants | 18 Participants | 32 Participants |
| Diagnosis traumatic brain injury | 11 Participants | 8 Participants | 19 Participants |
| Glasgow Coma Scale (Total) | 9.5 points STANDARD_DEVIATION 4 | 10 points STANDARD_DEVIATION 3.6 | 10 points STANDARD_DEVIATION 3.8 |
| Hemiparesis | 38 Participants | 38 Participants | 76 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 72 Participants | 80 Participants | 152 Participants |
| Sex: Female, Male Female | 37 Participants | 35 Participants | 72 Participants |
| Sex: Female, Male Male | 35 Participants | 45 Participants | 80 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 13 / 72 | 9 / 80 |
| other Total, other adverse events | 0 / 72 | 0 / 80 |
| serious Total, serious adverse events | 4 / 72 | 1 / 80 |
Outcome results
Primary
Participants With Complications With Central Access Including Insertion
Aggregation of all complications associated with central access including insertion
Time frame: up to 10 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PICC | Participants With Complications With Central Access Including Insertion | 14 Participants |
| Central Line | Participants With Complications With Central Access Including Insertion | 10 Participants |
p-value: 0.271Fisher Exact
Secondary
Number of Participants With a Central Line Associated Blood Stream Infection
A Central access associated infection (CLABSI)
Time frame: up to 10 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PICC | Number of Participants With a Central Line Associated Blood Stream Infection | 0 Participants |
| Central Line | Number of Participants With a Central Line Associated Blood Stream Infection | 0 Participants |
Secondary
Number of Participants With Deep Venous Thrombosis
Time frame: up to 10 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PICC | Number of Participants With Deep Venous Thrombosis | 4 Participants |
| Central Line | Number of Participants With Deep Venous Thrombosis | 0 Participants |
Secondary
Number of Patients With Complications Related to Insertion
Any complication of insertion including technical failure
Time frame: From the time of insertion until first confirmatory chest X-ray
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PICC | Number of Patients With Complications Related to Insertion | 8 Participants |
| Central Line | Number of Patients With Complications Related to Insertion | 6 Participants |