Vascular Access Complication
Conditions
Keywords
Difficult IV access, AccuCath, IV outcomes, patient satisfaction
Brief summary
Study objective is to evaluate user preference, time for procedure, insertion success rates, complications, completion of therapy and dwell time of the AccuCath 2.25 BC device placed in difficult IV access patients in the emergency department.
Detailed description
A one arm, prospective feasibility study using the AccuCath 2.25 BC Intravascular Catheter System placed in the upper arm with ultrasound guidance, and the lower arm with and without ultrasound guidance based on clinical assessment. Subjects will be subjected to a maximum of 4 attempts. If unsuccessful by the 4th attempt, alternatives will be considered as per current standard of care. Currently multiple IV attempts are made in difficult IV access patients without success. Patients are often escalated to more invasive lines due to the need for longer catheters without clinical indication. The study will evaluate the feasibility of AccuCath 2.25 BC as a low risk, lower cost alternative for this patient population in lieu of using a midline, peripherally inserted central line or central venous catheter when not clinically required for purposes of therapy.
Interventions
DEVICEAccuCath 2.25 BC Intravascular Catheter
Long peripheral IV catheter designed for difficult IV access patients requiring deeper vessel access, often used with ultrasound guidance.
Sponsors
C. R. Bard
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female, age \> 18 years old; 2. Capable and willing to give informed consent; 3. English speaking; 4. Acceptable candidate for an elective, non-emergent peripheral IV as determined by ordering physician; 5. Admitted to inpatient area for minimum of 24 hours, preferably for average hospital length of stay; 6. Difficult venous access patient as defined by either 2 failed initial attempts without ultrasound guidance or a history of difficult access plus the inability to directly visualize or palpate a target vein.
Exclusion criteria
1. Male or female, \< 18 years old; 2. Requirement for emergent IV placement (patient's condition would be compromised if there is a delay in IV placement); 3. Previous venous grafts or surgery at the target vessel access site; 4. Subjects with lymphedema or status-post mastectomy on affected side; 5. Currently involved in other investigational clinical trials (unless permission is granted by other study PI).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Catheter Attempts Required to Complete Successful PIV Placement | At IV insertion attempt, generally from 3-15 minutes |
| First Attempt Success Rate | At initial IV insertion attempt, generally from 3-15 minutes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complications | During IV dwell from initial insertion success through IV removal, usually ranges from 7-14 days but could be up to 29 days | Count of IV complications that require IV removal before completion of therapy. Includes infiltration, extravasation, phlebitis, occlusion, dislodgement, infection, leaking at site, pain at site |
| Dwell Time | Duration of IV dwell from initial insertion success through IV removal, usually ranges from 0-336 hours (0-14 days) but could be up to 696 hours (29 days) | IV dwell time in hours until IV is no longer needed or complicates. |
| Patient Satisfaction | At end of IV insertion, first 3-15 minutes of procedure | A 5-point Likert scale (1-5) was used for measurement of satisfaction with overall IV insertion experience. A score of 1 indicated the lowest satisfaction, while a score of 5 indicated the highest satisfaction. A score of 3-5 was considered positive. |
| Completion of Therapy | During IV dwell from initial insertion success through IV removal, usually ranges from 7-14 days but could be up to 29 days | Count of whether the catheter lasted for the duration of intended therapy without complication requiring early removal. |
| Time to Catheter Placement | At initial IV insertion attempt through successful cannulation, generally from 3-15 minutes | Time will be measured from initial vessel insertion through successful cannulation |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Attempts Prior to AccuCath 2.25 Use | Number of IV attempts made before patient identified as difficult access and enrolled in study, could range from 3-30 minutes during initial procedure attempts | Count of catheter attempts during initial insertion before patient identified as difficult IV access |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AccuCath 2.25 BC Intravascular Catheter Use of AccuCath 2.25 BC peripheral IV device for difficult IV access in emergency room patients who have had 2 previous attempts, identified as difficult IV access from patient history or non-palpable, non-visible veins.
AccuCath 2.25 BC Intravascular Catheter: Long peripheral IV catheter designed for difficult IV access patients requiring deeper vessel access, often used with ultrasound guidance. | 120 |
| Total | 120 |
Baseline characteristics
| Characteristic | AccuCath 2.25 BC Intravascular Catheter |
|---|---|
| Age, Continuous | 56.5 Year STANDARD_DEVIATION 19.06 |
| Race/Ethnicity, Customized Asian | 6 participants |
| Race/Ethnicity, Customized Black | 47 participants |
| Race/Ethnicity, Customized Caucasian | 55 participants |
| Race/Ethnicity, Customized Latino | 11 participants |
| Race/Ethnicity, Customized Other | 1 participants |
| Sex: Female, Male Female | 79 Participants |
| Sex: Female, Male Male | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 6 / 120 |
| serious Total, serious adverse events | 0 / 120 |
Outcome results
Primary
First Attempt Success Rate
Time frame: At initial IV insertion attempt, generally from 3-15 minutes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AccuCath 2.25 BC Intravascular Catheter | First Attempt Success Rate | 92 Participants |
Primary
Number of Catheter Attempts Required to Complete Successful PIV Placement
Time frame: At IV insertion attempt, generally from 3-15 minutes
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| AccuCath 2.25 BC Intravascular Catheter | Number of Catheter Attempts Required to Complete Successful PIV Placement | 1 Number of Catheters |
Secondary
Completion of Therapy
Count of whether the catheter lasted for the duration of intended therapy without complication requiring early removal.
Time frame: During IV dwell from initial insertion success through IV removal, usually ranges from 7-14 days but could be up to 29 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AccuCath 2.25 BC Intravascular Catheter | Completion of Therapy | 102 Participants |
Secondary
Complications
Count of IV complications that require IV removal before completion of therapy. Includes infiltration, extravasation, phlebitis, occlusion, dislodgement, infection, leaking at site, pain at site
Time frame: During IV dwell from initial insertion success through IV removal, usually ranges from 7-14 days but could be up to 29 days
Population: The total number of complications resulting from all 120 IV placement procedures is reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AccuCath 2.25 BC Intravascular Catheter | Complications | 18 Complications |
Secondary
Dwell Time
IV dwell time in hours until IV is no longer needed or complicates.
Time frame: Duration of IV dwell from initial insertion success through IV removal, usually ranges from 0-336 hours (0-14 days) but could be up to 696 hours (29 days)
Population: Admitted patients
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| AccuCath 2.25 BC Intravascular Catheter | Dwell Time | 90.98 hours |
Secondary
Patient Satisfaction
A 5-point Likert scale (1-5) was used for measurement of satisfaction with overall IV insertion experience. A score of 1 indicated the lowest satisfaction, while a score of 5 indicated the highest satisfaction. A score of 3-5 was considered positive.
Time frame: At end of IV insertion, first 3-15 minutes of procedure
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| AccuCath 2.25 BC Intravascular Catheter | Patient Satisfaction | 5 units on a scale |
Secondary
Patient Satisfaction
A 5-point Likert scale (1-5) was used for measurement of satisfaction with overall IV performance at IV removal. A score of 1 indicated the lowest satisfaction, while a score of 5 indicated the highest satisfaction. A score of 3-5 was considered positive.
Time frame: at IV removal, which can be up to a maximum of 29 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| AccuCath 2.25 BC Intravascular Catheter | Patient Satisfaction | 5 units on a scale |
Secondary
Time to Catheter Placement
Time will be measured from initial vessel insertion through successful cannulation
Time frame: At initial IV insertion attempt through successful cannulation, generally from 3-15 minutes
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| AccuCath 2.25 BC Intravascular Catheter | Time to Catheter Placement | 2 minutes |
Other Pre-specified
Number of Attempts Prior to AccuCath 2.25 Use
Count of catheter attempts during initial insertion before patient identified as difficult IV access
Time frame: Number of IV attempts made before patient identified as difficult access and enrolled in study, could range from 3-30 minutes during initial procedure attempts
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| AccuCath 2.25 BC Intravascular Catheter | Number of Attempts Prior to AccuCath 2.25 Use | 3 number of attempts |