Adult Patients With Peripherally Inserted Central Catheters
Conditions
Brief summary
The purpose of this study is to determine the rate and timing of interventions and complications related to the use of peripherally inserted central venous catheters in adult patients.
Interventions
None listed
Sponsors
Teleflex
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or Female Age \> 18 years requiring central venous access * Ability to comply with study requirements * Written Informed Consent
Exclusion criteria
* Previous enrollment in study * Current or recent upper extremity thrombosis, occlusion or stenosis * Previous axillary lymph node dissection * Skin inflammatory condition or rashes within 15 cm from insertion site * Pre-existing history of hypercoagulability unrelated to malignant disease * Participating in trial involving antithrombotic, anticoagulant or anti- infective drug therapies * Positive blood culture within 48 hours from planned PICC placement * Known, renal insufficiency with chronic creatinine levels \> 1.7 mg/dl
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of PICC Line Occlusions | Insertion to Removal / maximum 3 months | The incidence, severity and management of PICC line occlusions were recorded for each of the enrolled subjects. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Single Arm Study Patients requiring a standard 5 Fr Dual Lumen Peripherally Inserted Central Catheter (PICC) for an anticipated minimum 14 Days of antibiotic, chemotherpay or nutritional support were eligible for enrollment into this observational study. | 101 |
| Total | 101 |
Baseline characteristics
| Characteristic | Single Arm Study |
|---|---|
| Age, Continuous | 55 Years |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 88 Participants |
| Region of Enrollment United States | 101 participants |
| Sex: Female, Male Female | 36 Participants |
| Sex: Female, Male Male | 65 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 6 / 101 |
| serious Total, serious adverse events | 0 / 101 |
Outcome results
Primary
Rate of PICC Line Occlusions
The incidence, severity and management of PICC line occlusions were recorded for each of the enrolled subjects.
Time frame: Insertion to Removal / maximum 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Single Arm Study | Rate of PICC Line Occlusions | 37 percentage of enrolled subjects |