Trial Outcomes & Findings for Ultrasound Guided Catheter Length Survivability (NCT NCT03655106)

NCT ID: NCT03655106

Last Updated: 2020-03-11

Results Overview

Function is defined by a catheter's ability to draw back 5 ml of blood, flush with 5 ml normal saline without resistance, or if IV fluids or medication are continually infusing through the IV. Function is assessed daily by research staff.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 270 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2020-03-11

Participant Flow

Participant milestones

Measure	Standard Long IV 4.78 cm 20 g Catheter Placement of Standard Long IV 4.78 cm 20 g catheter Standard Long IV 4.78 cm 20 g catheter: Standard Long IV 4.78 cm 20 g catheter	Ultra-Long IV 6.35 cm 20 g Catheter Placement of Ultra-Long length IV 6.35 cm 20 g catheter Ultra-Long IV 6.35 cm 20 g catheter: Ultra-Long IV 6.35 cm 20 g catheter
Overall Study STARTED	135	135
Overall Study COMPLETED	126	131
Overall Study NOT COMPLETED	9	4

Reasons for withdrawal

Measure	Standard Long IV 4.78 cm 20 g Catheter Placement of Standard Long IV 4.78 cm 20 g catheter Standard Long IV 4.78 cm 20 g catheter: Standard Long IV 4.78 cm 20 g catheter	Ultra-Long IV 6.35 cm 20 g Catheter Placement of Ultra-Long length IV 6.35 cm 20 g catheter Ultra-Long IV 6.35 cm 20 g catheter: Ultra-Long IV 6.35 cm 20 g catheter
Overall Study Withdrawal by Subject	3	2
Overall Study Lost to Follow-up	2	1
Overall Study Duplicate Enrollment	1	1
Overall Study Protocol Violation	3	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Standard Long IV 4.78 cm 20 g Catheter n=126 Participants Placement of Standard Long IV 4.78 cm 20 g catheter Standard Long IV 4.78 cm 20 g catheter: Standard Long IV 4.78 cm 20 g catheter	Ultra-Long IV 6.35 cm 20 g Catheter n=131 Participants Placement of Ultra-Long length IV 6.35 cm 20 g catheter Ultra-Long IV 6.35 cm 20 g catheter: Ultra-Long IV 6.35 cm 20 g catheter	Total n=257 Participants Total of all reporting groups
Age, Continuous	58.2 years STANDARD_DEVIATION 18.6 • n=126 Participants	60.2 years STANDARD_DEVIATION 18.2 • n=131 Participants	59.2 years STANDARD_DEVIATION 17.8 • n=257 Participants
Sex: Female, Male Female	92 Participants n=126 Participants	92 Participants n=131 Participants	184 Participants n=257 Participants
Sex: Female, Male Male	34 Participants n=126 Participants	39 Participants n=131 Participants	73 Participants n=257 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	126 participants n=126 Participants	131 participants n=131 Participants	257 participants n=257 Participants

PRIMARY outcome

Timeframe: 30 days

Function is defined by a catheter's ability to draw back 5 ml of blood, flush with 5 ml normal saline without resistance, or if IV fluids or medication are continually infusing through the IV. Function is assessed daily by research staff.

Outcome measures

Measure	Standard Long IV 4.78 cm 20 g Catheter n=126 Participants Placement of Standard Long IV 4.78 cm 20 g catheter Standard Long IV 4.78 cm 20 g catheter: Standard Long IV 4.78 cm 20 g catheter	Ultra-Long IV 6.35 cm 20 g Catheter n=131 Participants Placement of Ultra-Long length IV 6.35 cm 20 g catheter Ultra-Long IV 6.35 cm 20 g catheter: Ultra-Long IV 6.35 cm 20 g catheter
Duration of IV Survival	92 hours Interval 71.0 to 120.0	136 hours Interval 116.0 to 311.0

SECONDARY outcome

Timeframe: 30 days

Number of patient with thrombosis upper extremity superficial or deep venous thrombosis as measured by venous doppler study in symptomatic patients

Outcome measures

Measure	Standard Long IV 4.78 cm 20 g Catheter n=126 Participants Placement of Standard Long IV 4.78 cm 20 g catheter Standard Long IV 4.78 cm 20 g catheter: Standard Long IV 4.78 cm 20 g catheter	Ultra-Long IV 6.35 cm 20 g Catheter n=131 Participants Placement of Ultra-Long length IV 6.35 cm 20 g catheter Ultra-Long IV 6.35 cm 20 g catheter: Ultra-Long IV 6.35 cm 20 g catheter
Thrombosis	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 30 days

Number of patient with infection as defined as the patient meeting the laboratory-confirmed bloodstream infection criteria as defined by the Centers for Disease Control.

Outcome measures

Measure	Standard Long IV 4.78 cm 20 g Catheter n=126 Participants Placement of Standard Long IV 4.78 cm 20 g catheter Standard Long IV 4.78 cm 20 g catheter: Standard Long IV 4.78 cm 20 g catheter	Ultra-Long IV 6.35 cm 20 g Catheter n=131 Participants Placement of Ultra-Long length IV 6.35 cm 20 g catheter Ultra-Long IV 6.35 cm 20 g catheter: Ultra-Long IV 6.35 cm 20 g catheter
Infection	0 Participants	0 Participants

Adverse Events

Standard Long IV 4.78 cm 20 g Catheter

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ultra-Long IV 6.35 cm 20 g Catheter

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Amit Bahl, MD

William Beaumont Hospitals

Phone: 2488982245

Email: amit.bahl@beaumont.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place