Trial Outcomes & Findings for Prospective Feasibility Trial of AccuCath 2.25" Blood Control (BC) Placed in Difficult Access Patients in the Emergency Department (NCT NCT02449798)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

120 participants

Primary outcome timeframe

At initial IV insertion attempt, generally from 3-15 minutes

Results posted on

2017-04-14

Participant Flow

Participant milestones

Participant milestones
Measure	AccuCath 2.25" BC Intravascular Catheter 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.
Overall Study STARTED	120
Overall Study COMPLETED	120
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AccuCath 2.25" BC Intravascular Catheter n=120 Participants 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.
Age, Continuous	56.5 Year STANDARD_DEVIATION 19.06 • n=99 Participants
Sex: Female, Male Female	79 Participants n=99 Participants
Sex: Female, Male Male	41 Participants n=99 Participants
Race/Ethnicity, Customized Caucasian	55 participants n=99 Participants
Race/Ethnicity, Customized Black	47 participants n=99 Participants
Race/Ethnicity, Customized Latino	11 participants n=99 Participants
Race/Ethnicity, Customized Asian	6 participants n=99 Participants
Race/Ethnicity, Customized Other	1 participants n=99 Participants

PRIMARY outcome

Timeframe: At initial IV insertion attempt, generally from 3-15 minutes

Outcome measures

Outcome measures
Measure	AccuCath 2.25" BC Intravascular Catheter n=120 Participants 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.
First Attempt Success Rate	92 Participants

PRIMARY outcome

Timeframe: At IV insertion attempt, generally from 3-15 minutes

Outcome measures

Outcome measures
Measure	AccuCath 2.25" BC Intravascular Catheter n=120 Participants 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.
Number of Catheter Attempts Required to Complete Successful PIV Placement	1 Number of Catheters Interval 1.0 to 3.0

SECONDARY outcome

Timeframe: At initial IV insertion attempt through successful cannulation, generally from 3-15 minutes

Time will be measured from initial vessel insertion through successful cannulation

Outcome measures

Outcome measures
Measure	AccuCath 2.25" BC Intravascular Catheter n=114 Participants 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.
Time to Catheter Placement	2 minutes Interval 0.0 to 30.0

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	AccuCath 2.25" BC Intravascular Catheter n=120 IV procedures 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.
Complications	18 Complications

SECONDARY outcome

Timeframe: 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

IV dwell time in hours until IV is no longer needed or complicates.

Outcome measures

Outcome measures
Measure	AccuCath 2.25" BC Intravascular Catheter n=85 Participants 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.
Dwell Time	90.98 hours Interval 1.6 to 535.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	AccuCath 2.25" BC Intravascular Catheter n=120 Participants 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.
Completion of Therapy	102 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	AccuCath 2.25" BC Intravascular Catheter n=120 Participants 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.
Patient Satisfaction	5 units on a scale Interval 1.0 to 5.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	AccuCath 2.25" BC Intravascular Catheter n=120 Participants 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.
Patient Satisfaction	5 units on a scale Interval 1.0 to 5.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	AccuCath 2.25" BC Intravascular Catheter n=120 Participants 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.
Number of Attempts Prior to AccuCath 2.25" Use	3 number of attempts Interval 0.0 to 12.0

Adverse Events

AccuCath 2.25" BC Intravascular Catheter

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	AccuCath 2.25" BC Intravascular Catheter n=120 participants at risk 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.
Product Issues Infiltration	5.0% 6/120 • 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). 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.

Additional Information

Gina Gilbert, BSN, RN

Bard Access Systems, Inc.

Phone: 407-489-0935

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place