AccuCath™ Intravenous (IV) Device Used by Vascular Access Team (VAT)

• Sponsor: C. R. Bard (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01937195
• Collaborator: (none)
• Enrollment: 95
• Location: 1
• Arm: 1
• Duration (Months): 19
• Patients Per Site Per Month: 5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vascular Access Complication	Device: AccuCath Intravenous Catheter System	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 95 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Prospective, Randomized, Controlled, Multicenter Comparison Between the AccuCath™ Intravenous Catheter System With Retractable Coiled Tip Guidewire and Conventional Peripheral Intravenous Catheters With a Vascular Access Team
• Study Start Date: Apr 1, 2013
• Actual Primary Completion Date: Jul 1, 2014
• Actual Study Completion Date: Nov 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AccuCath Intravenous Catheter System AccuCath Intravenous Catheter System will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal.	Device: AccuCath 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.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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).

2. 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).

3. 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.

4. 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.

5. 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.

6. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 89 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Evangelical Community Hospital	Lewisburg	Pennsylvania	United States	17837

Sponsors and Collaborators

• C. R. Bard

Investigators

• Principal Investigator: Norman R Anderson, RN, Evangelical Community Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: C. R. Bard
• ClinicalTrials.gov Identifier: NCT01937195
• Other Study ID Numbers: VPW-STP-00002
• First Posted: Sep 9, 2013
• Last Update Posted: Apr 20, 2017
• Last Verified: Mar 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by C. R. Bard: 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

Study Results

Participant Flow

Recruitment Details	Patients were enrolled from April 2013 through June 2014. Patients were admitted to the inpatient units at Evangelical Community Hospital.

Arm/Group Title	AccuCath Intravenous Catheter Device
Arm/Group Description	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.
Period Title: Overall Study
STARTED	95
COMPLETED	95
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	AccuCath Intravenous Catheter Device
Arm/Group Description	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.
Overall Participants	95
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	31 32.6%
>=65 years	64 67.4%
Sex: Female, Male (Count of Participants)
Female	62 65.3%
Male	33 34.7%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	95 100%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	95 100%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Successfully Inserted Peripheral IV Catheter Placement on First Attempt
Description	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

Outcome Measure Data

Analysis Population Description

Inpatients requiring IV therapy.

Arm/Group Title	AccuCath Intravenous Catheter Device
Arm/Group Description	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.
Measure Participants	95
Number (95% Confidence Interval) [percentage of participants]	85.3 89.8%

2. Secondary Outcome

Title	Percentage of Patients With Complications of Peripheral IV Therapy
Description	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

Outcome Measure Data

Analysis Population Description

Inpatient units requiring IV therapy.

Arm/Group Title	AccuCath Intravenous Catheter Device
Arm/Group Description	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.
Measure Participants	95
Number (95% Confidence Interval) [percentage of patients]	17.9

3. Secondary Outcome

Title	Completion of IV Therapy
Description	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

Outcome Measure Data

Analysis Population Description

Inpatients requiring IV therapy.

Arm/Group Title	AccuCath Intravenous Catheter Device
Arm/Group Description	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.
Measure Participants	95
Count of Participants [Participants]	78 82.1%

4. Secondary Outcome

Title	Catheter Dwell Time
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	AccuCath Intravenous Catheter Device
Arm/Group Description	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.
Measure Participants	95
Mean (95% Confidence Interval) [hours]	58

5. Secondary Outcome

Title	Percentage of Patients Who Identified as "Satisfied" With Catheter Performance at Catheter Insertion
Description	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

Outcome Measure Data

Analysis Population Description

Inpatients requiring IV therapy

Arm/Group Title	AccuCath Intravenous Catheter Device
Arm/Group Description	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.
Measure Participants	95
Number (95% Confidence Interval) [percentage of participants]	100.0 105.3%

6. Secondary Outcome

Title	Number of Participants Experiencing Adverse Events
Description	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

Outcome Measure Data

Analysis Population Description

Inpatients requiring IV therapy.

Arm/Group Title	AccuCath Intravenous Catheter Device
Arm/Group Description	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.
Measure Participants	95
Total	17 17.9%
Phlebitis	7 7.4%
Infiltration	6 6.3%
Leaking	3 3.2%
Dislodgement	1 1.1%

7. Secondary Outcome

Title	Percentage of Patients Who Identified as "Satisfied" With Catheter Performance at Catheter Removal
Description	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

Outcome Measure Data

Analysis Population Description

Inpatients requiring IV therapy

Arm/Group Title	AccuCath Intravenous Catheter Device
Arm/Group Description	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.
Measure Participants	95
Number (95% Confidence Interval) [percentage of participants]	97.9 103.1%

Adverse Events

Time Frame	During enrollment from April 2013 through June 2014.
Adverse Event Reporting Description	IV complications are anticipated events during conventional IV therapy and occur about 47% of the time.
Arm/Group Title	AccuCath Intravenous Catheter Device
Arm/Group Description	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.
All Cause Mortality
	AccuCath Intravenous Catheter Device
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	AccuCath Intravenous Catheter Device
	Affected / at Risk (%)	# Events
Total	0/95 (0%)
Other (Not Including Serious) Adverse Events
	AccuCath Intravenous Catheter Device
	Affected / at Risk (%)	# Events
Total	17/95 (17.9%)
Vascular disorders
Vascular Complication	17/95 (17.9%)	17

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.