Vascular Access Complication
Conditions
Keywords
IV Catheter comparison, AccuCath versus Conventional IV Catheters, IV Catheter Study, IV Catheter User Preference Comparison, First Attempt Success Rate for IV Catheters, AccuCath Device Performance, Complication Rates for IV Catheters, Average Dwell Time for IV Catheters, Patient Satisfaction with IV Catheters, Clinician Satisfaction with AccuCath Device Performance
Brief summary
The study will test a hypothesis that the AccuCath™ System will have a higher rate of successful first attempt peripheral intravenous (PIV) placement, higher completion of therapy, fewer complications, longer dwell times, and higher user satisfaction compared to Conventional IV Catheters.
Detailed description
Phase One is designed as a one-arm prospective study to compare patients using the AccuCath™ Intravenous Catheter System to the results found in literature. Phase Two is designed as a two-arm prospective randomized controlled study comparing the AccuCath™ Intravenous Catheter System to conventional PIV catheters. This study site will be completing Phase One only.
Interventions
DEVICEAccuCath Intravenous Catheter System
AccuCath IV Catheter System will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal. Results will be compared to published literature for conventional IV catheters.
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 89 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female, age \> or equal to 18 years or \< or equal to 89 years old; 2. Capable and willing to give informed consent; 3. English speaking; 4. Acceptable candidate for an elective, non-emergent PIV as determined by ordering physician; 5. Admitted to study inpatient unit.
Exclusion criteria
1. Male or female, \< 18 years old or \> 89 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. Currently involved in other investigational clinical trials (unless permission is granted by other study PI); 5. Females who are pregnant, planning to become pregnant within 3 months of the procedure, or lactating.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Successfully Inserted Peripheral IV Catheter Placement on First Attempt | Baseline/at catheter placement, usually 3-15 minutes initial during insertion procedure | The primary endpoint is to observe the rate of first attempt success (where the inserter only pierces the skin once and successfully places the PIV catheter in the vein) in patients requiring PIV access. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Completion of IV Therapy | Study exit/at catheter removal expected to be up to 7 days post placement | Completion of IV therapy will measure whether the catheter remained in place for the duration of required intravenous treatment during the inpatient stay (generally up to 7 days). |
| Catheter Dwell Time | Study exit/at catheter removal expected to be up to 7 days post placement | Will measure total catheter dwell time to the nearest hour (total time in hours for functioning catheter) up to 7 days. |
| Percentage of Patients With Complications of Peripheral IV Therapy | Study exit/at catheter removal expected to be up to 7 days post placement | Will measure the percentage of patients with (anticipated) complications of IV therapy - infection, occlusion, infiltration, extravasation, phlebitis, dislodgement, leaking/bleeding at site, patient complaints of pain without other identifiable cause, and other (up to 7 days). |
| Number of Participants Experiencing Adverse Events | baseline, and up to catheter removal expected to be no more than 7 days post placement | Will measure the number and severity of adverse events associated with peripheral IV initiation and indwelling catheter time up to 7 days. Adverse events are anticipated complications of IV therapy. |
| Percentage of Patients Who Identified as Satisfied With Catheter Performance at Catheter Removal | At catheter removal, which is expected to be up to 7 days post placement | Patients were surveyed regarding satisfaction with catheter performance with a 5-point Likert scale (1 the lowest, 5 the highest). Satisfaction was defined as a score of 3 to 5. |
| Percentage of Patients Who Identified as Satisfied With Catheter Performance at Catheter Insertion | Baseline at catheter insertion in the first 3-15 minutes after procedure | Patients were surveyed regarding satisfaction with catheter insertion with a 5-point Likert scale (1 the lowest, 5 the highest). Satisfaction was defined as a score of 3 to 5. |
Countries
United States
Participant flow
Recruitment details
Patients were enrolled from April 2013 through June 2014. Patients were admitted to the inpatient units at Evangelical Community Hospital.
Participants by arm
| Arm | Count |
|---|---|
| AccuCath Intravenous Catheter Device AccuCath Intravenous Catheter System: AccuCath IV Catheter System (study device) will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal. Results will be compared to published literature for conventional IV catheters. | 95 |
| Total | 95 |
Baseline characteristics
| Characteristic | AccuCath Intravenous Catheter Device |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 64 Participants |
| Age, Categorical Between 18 and 65 years | 31 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 95 Participants |
| Region of Enrollment United States | 95 participants |
| Sex: Female, Male Female | 62 Participants |
| Sex: Female, Male Male | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 17 / 95 |
| serious Total, serious adverse events | 0 / 95 |
Outcome results
Primary
Percentage of Participants With Successfully Inserted Peripheral IV Catheter Placement on First Attempt
The primary endpoint is to observe the rate of first attempt success (where the inserter only pierces the skin once and successfully places the PIV catheter in the vein) in patients requiring PIV access.
Time frame: Baseline/at catheter placement, usually 3-15 minutes initial during insertion procedure
Population: Inpatients requiring IV therapy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AccuCath Intravenous Catheter Device | Percentage of Participants With Successfully Inserted Peripheral IV Catheter Placement on First Attempt | 85.3 percentage of participants |
Secondary
Catheter Dwell Time
Will measure total catheter dwell time to the nearest hour (total time in hours for functioning catheter) up to 7 days.
Time frame: Study exit/at catheter removal expected to be up to 7 days post placement
| Arm | Measure | Value (MEAN) |
|---|---|---|
| AccuCath Intravenous Catheter Device | Catheter Dwell Time | 58 hours |
Secondary
Completion of IV Therapy
Completion of IV therapy will measure whether the catheter remained in place for the duration of required intravenous treatment during the inpatient stay (generally up to 7 days).
Time frame: Study exit/at catheter removal expected to be up to 7 days post placement
Population: Inpatients requiring IV therapy.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AccuCath Intravenous Catheter Device | Completion of IV Therapy | 78 Participants |
Secondary
Number of Participants Experiencing Adverse Events
Will measure the number and severity of adverse events associated with peripheral IV initiation and indwelling catheter time up to 7 days. Adverse events are anticipated complications of IV therapy.
Time frame: baseline, and up to catheter removal expected to be no more than 7 days post placement
Population: Inpatients requiring IV therapy.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AccuCath Intravenous Catheter Device | Number of Participants Experiencing Adverse Events | Dislodgement | 1 participants |
| AccuCath Intravenous Catheter Device | Number of Participants Experiencing Adverse Events | Total | 17 participants |
| AccuCath Intravenous Catheter Device | Number of Participants Experiencing Adverse Events | Phlebitis | 7 participants |
| AccuCath Intravenous Catheter Device | Number of Participants Experiencing Adverse Events | Infiltration | 6 participants |
| AccuCath Intravenous Catheter Device | Number of Participants Experiencing Adverse Events | Leaking | 3 participants |
Secondary
Percentage of Patients Who Identified as Satisfied With Catheter Performance at Catheter Insertion
Patients were surveyed regarding satisfaction with catheter insertion with a 5-point Likert scale (1 the lowest, 5 the highest). Satisfaction was defined as a score of 3 to 5.
Time frame: Baseline at catheter insertion in the first 3-15 minutes after procedure
Population: Inpatients requiring IV therapy
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AccuCath Intravenous Catheter Device | Percentage of Patients Who Identified as Satisfied With Catheter Performance at Catheter Insertion | 100.0 percentage of participants |
Secondary
Percentage of Patients Who Identified as Satisfied With Catheter Performance at Catheter Removal
Patients were surveyed regarding satisfaction with catheter performance with a 5-point Likert scale (1 the lowest, 5 the highest). Satisfaction was defined as a score of 3 to 5.
Time frame: At catheter removal, which is expected to be up to 7 days post placement
Population: Inpatients requiring IV therapy
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AccuCath Intravenous Catheter Device | Percentage of Patients Who Identified as Satisfied With Catheter Performance at Catheter Removal | 97.9 percentage of participants |
Secondary
Percentage of Patients With Complications of Peripheral IV Therapy
Will measure the percentage of patients with (anticipated) complications of IV therapy - infection, occlusion, infiltration, extravasation, phlebitis, dislodgement, leaking/bleeding at site, patient complaints of pain without other identifiable cause, and other (up to 7 days).
Time frame: Study exit/at catheter removal expected to be up to 7 days post placement
Population: Inpatient units requiring IV therapy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AccuCath Intravenous Catheter Device | Percentage of Patients With Complications of Peripheral IV Therapy | 17.9 percentage of patients |