AccuCath Guidewire Intravenous (IV) Device Versus Conventional IV Catheter In General Nursing Use

• Sponsor: C. R. Bard (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01943474
• Collaborator: (none)
• Enrollment: 248
• Location: 1
• Arms: 2
• Duration (Months): 6
• Patients Per Site Per Month: 41.2

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 (IV) 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 IV Catheter Device; Device: Conventional IV Catheter Device	N/A

Detailed Description

This study is designed to evaluate user/physician preference as it relates to use of a 510(k) cleared vascular access and catheter device compared with conventional needle/catheter vascular access devices, in terms of first stick success rates, dwell time, device-related vascular complications and adverse events and overall user and patient satisfaction. As noted above, the study is designed to formally test the hypothesis that the AccuCath™ System will exhibit superiority in terms of the rate of successful first attempt peripheral IV placement, higher completion of therapy, fewer complications, longer dwell times and higher user satisfaction compared to conventional intravenous catheters.

Study Design

• Study Type: Interventional
• Actual Enrollment: 248 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The AccuCath Intravenous Catheter System With Retractable Coiled Tip Guidewire and Conventional Peripheral Intravenous Catheters: A Prospective, Randomized, Controlled Comparison by General Hospital Nursing Staff
• Study Start Date: Apr 1, 2013
• Actual Primary Completion Date: Oct 1, 2013
• Actual Study Completion Date: Oct 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AccuCath IV Catheter Device AccuCath IV Catheter System will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal	Device: AccuCath IV Catheter Device; Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples.; Other Names: Rapid Intravascular Start System (RIVS) AccuCath System AccuCath IV device AccuCath AccuCath PIV AccuCath Short IV AccuCath IV Catheter
Active Comparator: Conventional IV Catheter Device Conventional IV catheter (current catheter) will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal	Device: Conventional IV Catheter Device; Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples.; Other Names: Insyte Autoguard Insyte Autoguard PIV Insyte Autoguard IV Catheter Insyte Autoguard IV device

Outcome Measures

Primary Outcome Measures

1. First Attempt Success Rate With Peripheral IV Catheter Placement [At catheter placement, an expected average of 10 minutes]

   The primary outcomes measure is to observe first attempt success rate in patients requiring peripheral IV access by documenting the number of catheter attempts (each new catheter) required to complete successful peripheral IV placement.

Secondary Outcome Measures

1. Completion of IV Therapy [Study exit/At catheter removal (~ up to 7 days)]

   Completion of IV therapy will measure whether the catheter remained in place for the duration of required intravenous treatment during the inpatient stay (~ up to 7 days).

2. Complications of Peripheral IV Therapy [From during to post IV catheter placement up to study exit (~ up to 7 days)]

   Will measure the rate of observed (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).

3. Catheter Dwell Time [Study Exit/At catheter removal (~ up to 7 days)]

   Will measure total catheter dwell time to the nearest hour (total time in hours for functioning catheter) ~ up to 7 days.

4. Patient Satisfaction At Insertion [At catheter insertion, initial 3-15 minutes after insertion procedure completed.]

   Will survey patients regarding satisfaction with catheter insertion using a 5-point Likert scale. 5 - Very satisfied, 4 - Somewhat satisfied, 3 - Neutral, 2 - Somewhat unsatisfied, 1 - Very unsatisfied. 3 and above are considered positive. 2 and below are considered negative.

5. Clinician Satisfaction [At completion of study after all patients have been enrolled (approximately 6 months from study initiation)]

   Will measure clinician satisfaction of the AccuCath IV device via a 5 point Likert scale survey based on overall catheter performance during experience and use. 5 - Very satisfied, 4 - Somewhat satisfied, 3 - Neutral, 2 - Somewhat unsatisfied, 1 - Very unsatisfied. 3 and above are considered positive. 2 and below are considered negative.

6. Adverse Events [During and post IV catheter placement until study exit (maximum of 6 months).]

   Will measure the number and severity of adverse events associated with peripheral IV initiation and indwelling catheter time (anticipated to be similar in both groups). This period will generally include up to 7 days of total IV dwell time.

7. Patient Satisfaction Comfort Comparison [Immediately after catheter insertion, within the first 3-15 minutes of insertion procedure.]

   Patient satisfaction with comfort of IV insertion compared to most recent previous IV insertion using a 5-point Likert scale. 5 - Very satisfied, 4 - Somewhat satisfied, 3 - Neutral, 2 - Somewhat unsatisfied, 1 - Very unsatisfied. 3 and above are considered positive. 2 and below are considered negative.

8. Patient Satisfaction With Overall IV Performance [At IV removal (usually after 1-7 days of IV dwell time)]

   Patient satisfaction with overall IV performance at IV removal using a 5-point Likert scale. 5 - Very satisfied, 4 - Somewhat satisfied, 3 - Neutral, 2 - Somewhat unsatisfied, 1 - Very unsatisfied. 3 and above are considered positive. 2 and below are considered negative.

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 ≥ 18 years or ≤ 89 years old;

2. Capable and willing to give informed consent;

3. English speaking;

4. Acceptable candidate for an elective, non-emergent peripheral intravenous (PIV) catheter placement 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 principal investigator [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	University Hospitals Case Medical Center	Cleveland	Ohio	United States	44106

Sponsors and Collaborators

• C. R. Bard

Investigators

• Principal Investigator: James Rowbottom, MD, University Hospitals Cleveland Medical Center
• Principal Investigator: Bette Idemoto, PhD, RN, University Hospitals Cleveland Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: C. R. Bard
• ClinicalTrials.gov Identifier: NCT01943474
• Other Study ID Numbers: DDVP-001/VPW-STP-00004
• First Posted: Sep 17, 2013
• Last Update Posted: Mar 9, 2017
• Last Verified: Jan 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

Arm/Group Title	AccuCath IV Catheter Device	Conventional IV Catheter Device
Arm/Group Description	AccuCath IV Catheter System will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal AccuCath IV Catheter Device: Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples.	Conventional IV catheter (current catheter) will be used for IV therapy during inpatient stay. Interventions include vascular access, administration of fluids, and removal of blood samples. Conventional IV Catheter Device: Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples.
Period Title: Overall Study
STARTED	123	125
COMPLETED	123	125
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	AccuCath IV Catheter Device	Conventional IV Catheter Device	Total
Arm/Group Description	AccuCath IV Catheter System will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal AccuCath IV Catheter Device: Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples.	Conventional IV catheter (current catheter) will be used for IV therapy during inpatient stay. Interventions include vascular access, administration of fluids, and removal of blood samples. Conventional IV Catheter Device: Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples.	Total of all reporting groups
Overall Participants	123	125	248
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	62.8 (15.5)	62.2 (14.5)	62.5 (15)
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	58 47.2%	69 55.2%	127 51.2%
>=65 years	65 52.8%	56 44.8%	121 48.8%
Sex: Female, Male (Count of Participants)
Female	49 39.8%	69 55.2%	118 47.6%
Male	74 60.2%	56 44.8%	130 52.4%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	1 0.8%	1 0.4%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	49 39.8%	54 43.2%	103 41.5%
White	73 59.3%	67 53.6%	140 56.5%
More than one race	1 0.8%	3 2.4%	4 1.6%
Unknown or Not Reported	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	2 1.6%	2 0.8%
Not Hispanic or Latino	123 100%	123 98.4%	246 99.2%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	123 100%	125 100%	248 100%

Outcome Measures

1. Primary Outcome

Title	First Attempt Success Rate With Peripheral IV Catheter Placement
Description	The primary outcomes measure is to observe first attempt success rate in patients requiring peripheral IV access by documenting the number of catheter attempts (each new catheter) required to complete successful peripheral IV placement.
Time Frame	At catheter placement, an expected average of 10 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	AccuCath IV Catheter Device	Conventional IV Catheter Device
Arm/Group Description	AccuCath IV Catheter System will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal AccuCath IV Catheter Device: Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples.	Conventional IV catheter (current catheter) will be used for IV therapy during inpatient stay. Interventions include vascular access, administration of fluids, and removal of blood samples. Conventional IV Catheter Device: Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples.
Measure Participants	123	125
Number (95% Confidence Interval) [percentage of participants]	89 72.4%	47 37.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	AccuCath IV Catheter Device, Conventional IV Catheter Device
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Fisher Exact
	Comments

2. 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 (~ up to 7 days).
Time Frame	Study exit/At catheter removal (~ up to 7 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	AccuCath IV Catheter Device	Conventional IV Catheter Device
Arm/Group Description	AccuCath IV Catheter System will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal AccuCath IV Catheter Device: Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples.	Conventional IV catheter (current catheter) will be used for IV therapy during inpatient stay. Interventions include vascular access, administration of fluids, and removal of blood samples. Conventional IV Catheter Device: Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples.
Measure Participants	123	125
Number (95% Confidence Interval) [percentage of participants]	89.4 72.7%	34.4 27.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	AccuCath IV Catheter Device, Conventional IV Catheter Device
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Fisher Exact
	Comments

3. Secondary Outcome

Title	Complications of Peripheral IV Therapy
Description	Will measure the rate of observed (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	From during to post IV catheter placement up to study exit (~ up to 7 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	AccuCath IV Catheter Device	Conventional IV Catheter Device
Arm/Group Description	AccuCath IV Catheter System will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal AccuCath IV Catheter Device: Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples.	Conventional IV catheter (current catheter) will be used for IV therapy during inpatient stay. Interventions include vascular access, administration of fluids, and removal of blood samples. Conventional IV Catheter Device: Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples.
Measure Participants	123	125
Number (95% Confidence Interval) [percentage of participants]	8 6.5%	52 41.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	AccuCath IV Catheter Device, Conventional IV Catheter Device
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Fisher Exact
	Comments

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 (~ up to 7 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	AccuCath IV Catheter Device	Conventional IV Catheter Device
Arm/Group Description	AccuCath IV Catheter System will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal AccuCath IV Catheter Device: Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples.	Conventional IV catheter (current catheter) will be used for IV therapy during inpatient stay. Interventions include vascular access, administration of fluids, and removal of blood samples. Conventional IV Catheter Device: Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples.
Measure Participants	123	125
Mean (Standard Deviation) [hours]	105 (61)	35 (25)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	AccuCath IV Catheter Device, Conventional IV Catheter Device
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 2 sided
	Comments

5. Secondary Outcome

Title	Patient Satisfaction At Insertion
Description	Will survey patients regarding satisfaction with catheter insertion using a 5-point Likert scale. 5 - Very satisfied, 4 - Somewhat satisfied, 3 - Neutral, 2 - Somewhat unsatisfied, 1 - Very unsatisfied. 3 and above are considered positive. 2 and below are considered negative.
Time Frame	At catheter insertion, initial 3-15 minutes after insertion procedure completed.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	AccuCath IV Catheter Device	Conventional IV Catheter Device
Arm/Group Description	AccuCath IV Catheter System will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal AccuCath IV Catheter Device: Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples.	Conventional IV catheter (current catheter) will be used for IV therapy during inpatient stay. Interventions include vascular access, administration of fluids, and removal of blood samples. Conventional IV Catheter Device: Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples.
Measure Participants	123	125
Mean (Standard Deviation) [units on a scale]	4.6 (0.69)	3.0 (1.27)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	AccuCath IV Catheter Device, Conventional IV Catheter Device
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 2 sided
	Comments

6. Secondary Outcome

Title	Clinician Satisfaction
Description	Will measure clinician satisfaction of the AccuCath IV device via a 5 point Likert scale survey based on overall catheter performance during experience and use. 5 - Very satisfied, 4 - Somewhat satisfied, 3 - Neutral, 2 - Somewhat unsatisfied, 1 - Very unsatisfied. 3 and above are considered positive. 2 and below are considered negative.
Time Frame	At completion of study after all patients have been enrolled (approximately 6 months from study initiation)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	AccuCath IV Catheter Device
Arm/Group Description	AccuCath IV Catheter System will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal AccuCath IV Catheter Device: Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples.
Measure Participants	18
Mean (Full Range) [units on a scale]	4

7. Secondary Outcome

Title	Adverse Events
Description	Will measure the number and severity of adverse events associated with peripheral IV initiation and indwelling catheter time (anticipated to be similar in both groups). This period will generally include up to 7 days of total IV dwell time.
Time Frame	During and post IV catheter placement until study exit (maximum of 6 months).

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	AccuCath IV Catheter Device	Conventional IV Catheter Device
Arm/Group Description	AccuCath IV Catheter System will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal AccuCath IV Catheter Device: Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples.	Conventional IV catheter (current catheter) will be used for IV therapy during inpatient stay. Interventions include vascular access, administration of fluids, and removal of blood samples. Conventional IV Catheter Device: Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples.
Measure Participants	123	125
Infiltration	2.4 2%	26.4 21.1%
Phlebitis	0.8 0.7%	8.8 7%
Leaking	0.8 0.7%	5.6 4.5%
Occlusion	1.6 1.3%	5.6 4.5%
Dislodgement	2.4 2%	4.8 3.8%

8. Secondary Outcome

Title	Patient Satisfaction Comfort Comparison
Description	Patient satisfaction with comfort of IV insertion compared to most recent previous IV insertion using a 5-point Likert scale. 5 - Very satisfied, 4 - Somewhat satisfied, 3 - Neutral, 2 - Somewhat unsatisfied, 1 - Very unsatisfied. 3 and above are considered positive. 2 and below are considered negative.
Time Frame	Immediately after catheter insertion, within the first 3-15 minutes of insertion procedure.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	AccuCath IV Catheter Device	Conventional IV Catheter Device
Arm/Group Description	AccuCath IV Catheter System will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal AccuCath IV Catheter Device: Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples.	Conventional IV catheter (current catheter) will be used for IV therapy during inpatient stay. Interventions include vascular access, administration of fluids, and removal of blood samples. Conventional IV Catheter Device: Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples.
Measure Participants	123	125
Mean (Standard Deviation) [units on a scale]	4.2 (1.02)	2.86 (1.18)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	AccuCath IV Catheter Device, Conventional IV Catheter Device
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 2 sided
	Comments

9. Secondary Outcome

Title	Patient Satisfaction With Overall IV Performance
Description	Patient satisfaction with overall IV performance at IV removal using a 5-point Likert scale. 5 - Very satisfied, 4 - Somewhat satisfied, 3 - Neutral, 2 - Somewhat unsatisfied, 1 - Very unsatisfied. 3 and above are considered positive. 2 and below are considered negative.
Time Frame	At IV removal (usually after 1-7 days of IV dwell time)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	AccuCath IV Catheter Device	Conventional IV Catheter Device
Arm/Group Description	AccuCath IV Catheter System will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal AccuCath IV Catheter Device: Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples.	Conventional IV catheter (current catheter) will be used for IV therapy during inpatient stay. Interventions include vascular access, administration of fluids, and removal of blood samples. Conventional IV Catheter Device: Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples.
Measure Participants	123	125
Mean (Standard Deviation) [units on a scale]	4.84 (0.41)	2.84 (1.01)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	AccuCath IV Catheter Device, Conventional IV Catheter Device
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 2 sided
	Comments

Adverse Events

Time Frame	During study enrollment from April 2013 - June 2013
Adverse Event Reporting Description	Adverse events are the anticipated complications of IV therapy.
Arm/Group Title	AccuCath IV Catheter Device		Conventional IV Catheter Device
Arm/Group Description	AccuCath IV Catheter System will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal AccuCath IV Catheter Device: Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples.		Conventional IV catheter (current catheter) will be used for IV therapy during inpatient stay. Interventions include vascular access, administration of fluids, and removal of blood samples. Conventional IV Catheter Device: Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples.
All Cause Mortality
	AccuCath IV Catheter Device		Conventional IV Catheter Device
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	AccuCath IV Catheter Device		Conventional IV Catheter Device
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/123 (0%)		0/125 (0%)
Other (Not Including Serious) Adverse Events
	AccuCath IV Catheter Device		Conventional IV Catheter Device
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/123 (8.1%)		65/125 (52%)
General disorders
Pain	0/123 (0%)		2/125 (1.6%)
Infections and infestations
Infection	0/123 (0%)		1/125 (0.8%)
Vascular disorders
Phlebitis	1/123 (0.8%)		11/125 (8.8%)
Infiltration	3/123 (2.4%)		33/125 (26.4%)
Dislodgement	3/123 (2.4%)		6/125 (4.8%)
Occlusion	2/123 (1.6%)		7/125 (5.6%)
Leaking	1/123 (0.8%)		7/125 (5.6%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.