Trial Outcomes & Findings for Superior Venous Access, Midline vs Ultrasound IVs (NCT NCT03440944)
NCT ID: NCT03440944
Last Updated: 2021-04-29
Results Overview
Total number and percentage of device failures within 72 hours of placement based on midline and ultrasound guided peripheral IV catheter. Medical record review and in person visits with medical treatment teams and patients were used to assess if device failure occurred within 72 hours. Device failure was determined by needing to have any device replaced or removed for clinical care.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
18 participants
Primary outcome timeframe
72 hours after device placement
Results posted on
2021-04-29
Participant Flow
Participant milestones
| Measure |
Ultrasound Guided Peripheral IV Catheter
Patients if randomized to this group will receive a standard ultrasound guided peripheral IV. The IV is 4.77cm in length.
Ultrasound Guided Peripheral IV Catheter: Patients randomized to this arm will receive an ultrasound guided peripheral IV catheter.
|
Midline Catheter
Patients if randomized to this group will receive a midline catheter. The catheter is 10cm in length.
Midline Catheter: Patients randomized to this group will receive a midline catheter. The catheter is 10cm in length.
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
9
|
|
Overall Study
COMPLETED
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Ultrasound Guided Peripheral IV Catheter
Patients if randomized to this group will receive a standard ultrasound guided peripheral IV. The IV is 4.77cm in length.
Ultrasound Guided Peripheral IV Catheter: Patients randomized to this arm will receive an ultrasound guided peripheral IV catheter.
|
Midline Catheter
Patients if randomized to this group will receive a midline catheter. The catheter is 10cm in length.
Midline Catheter: Patients randomized to this group will receive a midline catheter. The catheter is 10cm in length.
|
|---|---|---|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
No Acceptable Vasculature
|
0
|
1
|
Baseline Characteristics
Superior Venous Access, Midline vs Ultrasound IVs
Baseline characteristics by cohort
| Measure |
Ultrasound Guided Peripheral IV Catheter
n=8 Participants
Patients if randomized to this group will receive a standard ultrasound guided peripheral IV. The IV is 4.88cm in length.
Ultrasound Guided Peripheral IV Catheter: Patients randomized to this arm will receive an ultrasound guided peripheral IV catheter.
|
Midline Catheter
n=8 Participants
Patients if randomized to this group will receive a midline catheter. The catheter is 10cm in length.
Midline Catheter: Patients randomized to this group will receive a midline catheter. The catheter is 10cm in length.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Age, Continuous
|
42 years
n=93 Participants
|
53 years
n=4 Participants
|
49 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
8 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 72 hours after device placementPopulation: Patients who completed therapy within 72 hours were considered non-failure
Total number and percentage of device failures within 72 hours of placement based on midline and ultrasound guided peripheral IV catheter. Medical record review and in person visits with medical treatment teams and patients were used to assess if device failure occurred within 72 hours. Device failure was determined by needing to have any device replaced or removed for clinical care.
Outcome measures
| Measure |
Ultrasound Guided Peripheral IV Catheter
n=8 Participants
Patients if randomized to this group will receive a standard ultrasound guided peripheral IV. The IV is 4.77cm in length.
Ultrasound Guided Peripheral IV Catheter: Patients randomized to this arm will receive an ultrasound guided peripheral IV catheter.
|
Midline Catheter
n=8 Participants
Patients if randomized to this group will receive a midline catheter. The catheter is 10cm in length.
Midline Catheter: Patients randomized to this group will receive a midline catheter. The catheter is 10cm in length.
|
|---|---|---|
|
Device Failures Within 72 Hours
Device Failure within 72 hours
|
6 Participants
|
1 Participants
|
|
Device Failures Within 72 Hours
No Device Failure within 72 hours
|
2 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: from catheter insertionPopulation: Time taken to place each device
The time it takes to insert the IV catheter will be documented in minutes for each study participant.
Outcome measures
| Measure |
Ultrasound Guided Peripheral IV Catheter
n=8 Participants
Patients if randomized to this group will receive a standard ultrasound guided peripheral IV. The IV is 4.77cm in length.
Ultrasound Guided Peripheral IV Catheter: Patients randomized to this arm will receive an ultrasound guided peripheral IV catheter.
|
Midline Catheter
n=8 Participants
Patients if randomized to this group will receive a midline catheter. The catheter is 10cm in length.
Midline Catheter: Patients randomized to this group will receive a midline catheter. The catheter is 10cm in length.
|
|---|---|---|
|
IV Catheter Insertion Time
|
9 minutes
Interval 7.0 to 13.0
|
17.5 minutes
Interval 14.0 to 25.0
|
SECONDARY outcome
Timeframe: from catheter insertion up to 30 daysPopulation: Number of additional IV (including Midline) catheters placed
The total number of replacement IV catheters will be documented. This will be assessed based on each group (Ultrasound Guided Peripheral IV Catheter and Midline Catheter).
Outcome measures
| Measure |
Ultrasound Guided Peripheral IV Catheter
n=8 Participants
Patients if randomized to this group will receive a standard ultrasound guided peripheral IV. The IV is 4.77cm in length.
Ultrasound Guided Peripheral IV Catheter: Patients randomized to this arm will receive an ultrasound guided peripheral IV catheter.
|
Midline Catheter
n=8 Participants
Patients if randomized to this group will receive a midline catheter. The catheter is 10cm in length.
Midline Catheter: Patients randomized to this group will receive a midline catheter. The catheter is 10cm in length.
|
|---|---|---|
|
Total Number of Replacement Catheters
|
13 additional IV access devices
|
1 additional IV access devices
|
SECONDARY outcome
Timeframe: from catheter insertion up to 30 daysThe mean costs per patient associated with the placement and replacement of catheters for each participant will be calculated.
Outcome measures
| Measure |
Ultrasound Guided Peripheral IV Catheter
n=8 Participants
Patients if randomized to this group will receive a standard ultrasound guided peripheral IV. The IV is 4.77cm in length.
Ultrasound Guided Peripheral IV Catheter: Patients randomized to this arm will receive an ultrasound guided peripheral IV catheter.
|
Midline Catheter
n=8 Participants
Patients if randomized to this group will receive a midline catheter. The catheter is 10cm in length.
Midline Catheter: Patients randomized to this group will receive a midline catheter. The catheter is 10cm in length.
|
|---|---|---|
|
Catheter Related Costs
|
38.25 US Dollars
Standard Deviation 21.95
|
28.88 US Dollars
Standard Deviation 4.68
|
SECONDARY outcome
Timeframe: 72 hours after catheter insertionPopulation: Patients who stayed for 72 hours, preference to have midline over ultrasound guided peripheral IV catheter. Patients discharged prior to 72 hours of therapy are not included in the reported results. For the Midline Catheter arm only 3 participants stayed at least 72 hours; 5 participants did not complete the satisfaction survey.
Participant experience and satisfaction will be assessed with a short survey that will be given to participants who stay at least 72 hours after catheter insertion.
Outcome measures
| Measure |
Ultrasound Guided Peripheral IV Catheter
n=8 Participants
Patients if randomized to this group will receive a standard ultrasound guided peripheral IV. The IV is 4.77cm in length.
Ultrasound Guided Peripheral IV Catheter: Patients randomized to this arm will receive an ultrasound guided peripheral IV catheter.
|
Midline Catheter
n=3 Participants
Patients if randomized to this group will receive a midline catheter. The catheter is 10cm in length.
Midline Catheter: Patients randomized to this group will receive a midline catheter. The catheter is 10cm in length.
|
|---|---|---|
|
Patient Satisfaction
Prefer Midline
|
4 Participants
|
3 Participants
|
|
Patient Satisfaction
Unsure
|
3 Participants
|
0 Participants
|
|
Patient Satisfaction
No
|
1 Participants
|
0 Participants
|
Adverse Events
Ultrasound Guided Peripheral IV Catheter
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Midline Catheter
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ultrasound Guided Peripheral IV Catheter
n=8 participants at risk
Patients if randomized to this group will receive a standard ultrasound guided peripheral IV. The IV is 4.77cm in length.
Ultrasound Guided Peripheral IV Catheter: Patients randomized to this arm will receive an ultrasound guided peripheral IV catheter.
|
Midline Catheter
n=8 participants at risk
Patients if randomized to this group will receive a midline catheter. The catheter is 10cm in length.
Midline Catheter: Patients randomized to this group will receive a midline catheter. The catheter is 10cm in length.
|
|---|---|---|
|
Surgical and medical procedures
Device Failure
|
75.0%
6/8 • Number of events 6 • Within 30 days of IV or Midline device placement
Adverse Event included device failure or required replacement.
|
12.5%
1/8 • Number of events 1 • Within 30 days of IV or Midline device placement
Adverse Event included device failure or required replacement.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place