Trial Outcomes & Findings for Comparison of Different Techniques on First Attempt Success in Difficult Vascular Access Patients (NCT NCT04821362)
NCT ID: NCT04821362
Last Updated: 2021-12-03
Results Overview
The success numbers of the first attempt during the implementation of all three methods
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
270 participants
Primary outcome timeframe
From the time of randomization until the time of the first successful attempt, up to 30 minutes.
Results posted on
2021-12-03
Participant Flow
Patients who need urgent care, \<18 years, pregnant, and declined to participate were not included in to study groups.
Participant milestones
| Measure |
Standard Technique Group
In this group, peripheral intravenous catheter insertion will be performed routinely.
|
Ultrasound Group
In this group, peripheral intravenous catheter insertion will be performed with ultrasound. A linear probe will be used for procedures.
Ultrasound group: In the ultrasound group, the nurses will insert the cannulas to the peripheral veins as horizontally and longitudinally with the linear probe.
|
Near Infrared Device Group
In this group, peripheral intravenous catheter insertion will be performed with AccuVein AV 400.
Near Infrared Device Group: In the near infrared device group, the nurses will insert the cannulas to the peripheral veins with AccuVein AV 400.
|
|---|---|---|---|
|
Overall Study
STARTED
|
90
|
90
|
90
|
|
Overall Study
COMPLETED
|
90
|
90
|
90
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Different Techniques on First Attempt Success in Difficult Vascular Access Patients
Baseline characteristics by cohort
| Measure |
Standard Technique Group
n=90 Participants
In this group, peripheral intravenous catheter insertion will be performed routinely.
|
Ultrasound Group
n=90 Participants
In this group, peripheral intravenous catheter insertion will be performed with ultrasound. A linear probe will be used for procedures.
Ultrasound group: In the ultrasound group, the nurses will insert the cannulas to the peripheral veins as horizontally and longitudinally with the linear probe.
|
Near Infrared Device Group
n=90 Participants
In this group, peripheral intravenous catheter insertion will be performed with AccuVein AV 400.
Near Infrared Device Group: In the near infrared device group, the nurses will insert the cannulas to the peripheral veins with AccuVein AV 400.
|
Total
n=270 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
41 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
137 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
49 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
133 Participants
n=4 Participants
|
|
Age, Continuous
|
68.5 years
n=5 Participants
|
64 years
n=7 Participants
|
64 years
n=5 Participants
|
65 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
56 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
167 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
103 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
90 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
270 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
Turkey
|
90 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
270 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From the time of randomization until the time of the first successful attempt, up to 30 minutes.The success numbers of the first attempt during the implementation of all three methods
Outcome measures
| Measure |
Standard Technique Group
n=90 Participants
In this group, peripheral intravenous catheter insertion will be performed routinely.
|
Ultrasound Group
n=90 Participants
In this group, peripheral intravenous catheter insertion will be performed with ultrasound. A linear probe will be used for procedures.
Ultrasound group: In the ultrasound group, the nurses will insert the cannulas to the peripheral veins as horizontally and longitudinally with the linear probe.
|
Near Infrared Device Group
n=90 Participants
In this group, peripheral intravenous catheter insertion will be performed with AccuVein AV 400.
Near Infrared Device Group: In the near infrared device group, the nurses will insert the cannulas to the peripheral veins with AccuVein AV 400.
|
|---|---|---|---|
|
Number of Participants With Success in the First Attempt
|
56 Participants
|
71 Participants
|
53 Participants
|
SECONDARY outcome
Timeframe: From the time of the tourniquet application, until the procedure successfully achieved, up to 1 hour.Time of the intravenous catheter placement procedure
Outcome measures
| Measure |
Standard Technique Group
n=90 Participants
In this group, peripheral intravenous catheter insertion will be performed routinely.
|
Ultrasound Group
n=90 Participants
In this group, peripheral intravenous catheter insertion will be performed with ultrasound. A linear probe will be used for procedures.
Ultrasound group: In the ultrasound group, the nurses will insert the cannulas to the peripheral veins as horizontally and longitudinally with the linear probe.
|
Near Infrared Device Group
n=90 Participants
In this group, peripheral intravenous catheter insertion will be performed with AccuVein AV 400.
Near Infrared Device Group: In the near infrared device group, the nurses will insert the cannulas to the peripheral veins with AccuVein AV 400.
|
|---|---|---|---|
|
Procedure Time.
|
72 Seconds
Interval 47.0 to 134.0
|
107 Seconds
Interval 69.0 to 228.0
|
82 Seconds
Interval 61.0 to 163.0
|
SECONDARY outcome
Timeframe: Up to 1 hour.The method used as a rescue method when the primary method fails to achieve success.
Outcome measures
| Measure |
Standard Technique Group
n=90 Participants
In this group, peripheral intravenous catheter insertion will be performed routinely.
|
Ultrasound Group
n=90 Participants
In this group, peripheral intravenous catheter insertion will be performed with ultrasound. A linear probe will be used for procedures.
Ultrasound group: In the ultrasound group, the nurses will insert the cannulas to the peripheral veins as horizontally and longitudinally with the linear probe.
|
Near Infrared Device Group
n=90 Participants
In this group, peripheral intravenous catheter insertion will be performed with AccuVein AV 400.
Near Infrared Device Group: In the near infrared device group, the nurses will insert the cannulas to the peripheral veins with AccuVein AV 400.
|
|---|---|---|---|
|
Patients Who Need Rescue Methods
|
17 Participants
|
17 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: From the time of randomization until the time of the successful attempt, up to 1 hour.Number of attempts to successfully insert peripheral vascular cateter.
Outcome measures
| Measure |
Standard Technique Group
n=90 Participants
In this group, peripheral intravenous catheter insertion will be performed routinely.
|
Ultrasound Group
n=90 Participants
In this group, peripheral intravenous catheter insertion will be performed with ultrasound. A linear probe will be used for procedures.
Ultrasound group: In the ultrasound group, the nurses will insert the cannulas to the peripheral veins as horizontally and longitudinally with the linear probe.
|
Near Infrared Device Group
n=90 Participants
In this group, peripheral intravenous catheter insertion will be performed with AccuVein AV 400.
Near Infrared Device Group: In the near infrared device group, the nurses will insert the cannulas to the peripheral veins with AccuVein AV 400.
|
|---|---|---|---|
|
Number of Attempts
|
1 attempts
Interval 1.0 to 2.0
|
1 attempts
Interval 1.0 to 1.0
|
1 attempts
Interval 1.0 to 2.0
|
Adverse Events
Standard Technique Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ultrasound Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Near Infrared Device Group
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place