Prospective Feasibility Trial of AccuCath 2.25" Blood Control (BC) Placed in Difficult Access Patients in the Emergency Department

• Sponsor: C. R. Bard (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02449798
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arm: 1
• Duration (Months): 4
• Patients Per Site Per Month: 29.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vascular Access Complication	Device: AccuCath 2.25" BC Intravascular Catheter	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 120 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Prospective Feasibility Trial of AccuCath 2.25" BC Intravascular Catheter System With Retractable Coiled Tip Guidewire Placed in Difficult Access Patients in the Emergency Department
• Study Start Date: Mar 1, 2015
• Actual Primary Completion Date: Jun 1, 2015
• Actual Study Completion Date: Jul 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Device: 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.; Other Names: AccuCath AccuCath peripheral IV AccuCath IV device AccuCath catheter system

Outcome Measures

Primary Outcome Measures

1. First Attempt Success Rate [At initial IV insertion attempt, generally from 3-15 minutes]

2. Number of Catheter Attempts Required to Complete Successful PIV Placement [At IV insertion attempt, generally from 3-15 minutes]

Secondary Outcome Measures

1. 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

2. 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

3. 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.

4. 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.

5. 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.

6. Patient Satisfaction [at IV removal, which can be up to a maximum of 29 days]

   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.

Other Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	North Shore - Long Island Jewish Health System	Manhasset	New York	United States	11030

Sponsors and Collaborators

• C. R. Bard

Investigators

• Principal Investigator: Christopher Raio, MD, Northwell Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: C. R. Bard
• ClinicalTrials.gov Identifier: NCT02449798
• Other Study ID Numbers: VPW-STP-00007
• First Posted: May 20, 2015
• Last Update Posted: Apr 14, 2017
• Last Verified: Mar 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by C. R. Bard: Difficult IV access; AccuCath; IV outcomes; patient satisfaction
• Additional relevant MeSH terms: Emergencies

Study Results

Participant Flow

Arm/Group Title	AccuCath 2.25" BC Intravascular Catheter
Arm/Group Description	Use of AccuCath 2.25" Blood Control (BC) peripheral intravenous (PIV) 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.
Period Title: Overall Study
STARTED	120
COMPLETED	120
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	AccuCath 2.25" BC Intravascular Catheter
Arm/Group Description	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.
Overall Participants	120
Age (Year) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Year]	56.5 (19.06)
Sex: Female, Male (Count of Participants)
Female	79 65.8%
Male	41 34.2%
Race/Ethnicity, Customized (participants) [Number]
Caucasian	55 45.8%
Black	47 39.2%
Latino	11 9.2%
Asian	6 5%
Other	1 0.8%

Outcome Measures

1. Primary Outcome

Title	First Attempt Success Rate
Time Frame	At initial IV insertion attempt, generally from 3-15 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	AccuCath 2.25" BC Intravascular Catheter
Arm/Group Description	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.
Measure Participants	120
Count of Participants [Participants]	92 76.7%

2. Primary Outcome

Title	Number of Catheter Attempts Required to Complete Successful PIV Placement
Time Frame	At IV insertion attempt, generally from 3-15 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	AccuCath 2.25" BC Intravascular Catheter
Arm/Group Description	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.
Measure Participants	120
Median (Full Range) [Number of Catheters]	1

3. Secondary Outcome

Title	Time to Catheter Placement
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	AccuCath 2.25" BC Intravascular Catheter
Arm/Group Description	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.
Measure Participants	114
Median (Full Range) [minutes]	2

4. Secondary Outcome

Title	Complications
Description	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

Outcome Measure Data

Analysis Population Description

The total number of complications resulting from all 120 IV placement procedures is reported.

Arm/Group Title	AccuCath 2.25" BC Intravascular Catheter
Arm/Group Description	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.
Measure Participants	120
Measure IV procedures	120
Number [Complications]	18

5. Secondary Outcome

Title	Dwell Time
Description	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)

Outcome Measure Data

Analysis Population Description

Admitted patients

Arm/Group Title	AccuCath 2.25" BC Intravascular Catheter
Arm/Group Description	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.
Measure Participants	85
Median (Full Range) [hours]	90.98

6. Secondary Outcome

Title	Completion of Therapy
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	AccuCath 2.25" BC Intravascular Catheter
Arm/Group Description	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.
Measure Participants	120
Count of Participants [Participants]	102 85%

7. Secondary Outcome

Title	Patient Satisfaction
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	AccuCath 2.25" BC Intravascular Catheter
Arm/Group Description	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.
Measure Participants	120
Median (Full Range) [units on a scale]	5

8. Secondary Outcome

Title	Patient Satisfaction
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	AccuCath 2.25" BC Intravascular Catheter
Arm/Group Description	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.
Measure Participants	120
Median (Full Range) [units on a scale]	5

9. Other Pre-specified Outcome

Title	Number of Attempts Prior to AccuCath 2.25" Use
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	AccuCath 2.25" BC Intravascular Catheter
Arm/Group Description	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.
Measure Participants	120
Median (Full Range) [number of attempts]	3

Adverse Events

Time Frame	Treatment emergent anticipated and unanticipated serious and non-serious adverse events were recorded from catheter insertion until catheter removal. Catheter dwell time usually ranges from 0-336 hours (0-14 days) but could be up to 696 hours (29 days).
Adverse Event Reporting Description	The number and proportion of subjects in the Safety Patient Set reporting any given adverse event were tabulated according to the worst severity reported during the study period.
Arm/Group Title	AccuCath 2.25" BC Intravascular Catheter
Arm/Group Description	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.
All Cause Mortality
	AccuCath 2.25" BC Intravascular Catheter
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	AccuCath 2.25" BC Intravascular Catheter
	Affected / at Risk (%)	# Events
Total	0/120 (0%)
Other (Not Including Serious) Adverse Events
	AccuCath 2.25" BC Intravascular Catheter
	Affected / at Risk (%)	# Events
Total	6/120 (5%)
Product Issues
Infiltration	6/120 (5%)

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.