Trial Outcomes & Findings for Impact of PIVC Length and Gauge on Catheter Indwell Time (NCT NCT04344314)
NCT ID: NCT04344314
Last Updated: 2024-05-16
Results Overview
Catheter indwell time for each PIVC, expressed in hours
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
72 hrs
Results posted on
2024-05-16
Participant Flow
40 enrolled and randomized subjects
Unit of analysis: arms
Participant milestones
| Measure |
PIVC 22G, 1 Inch Length
One participant receives 2 Peripheral Intravenous Catheters (PIVC) with the same Gauge (22G), one in each arm.
The length of the catheter is different in each arm, in this case: 1 Inch.
Choice of catheter size and length is randomized per participant, as well as which arm is first catharized.
|
PIVC 22G, 1.75 Inch Length
One participant receives 2 Peripheral Intravenous Catheters (PIVC) with the same Gauge (22G), one in each arm.
The length of the catheter is different in each arm, in this case: 1.75 Inch.
Choice of catheter size and length is randomized per participant, as well as which arm is first catharized.
|
PIVC 20G, 1 Inch Length
One participant receives 2 Peripheral Intravenous Catheters (PIVC) with the same Gauge (20G), one in each arm.
The length of the catheter is different in each arm, in this case: 1 Inch.
Choice of catheter size and length is randomized per participant, as well as which arm is first catharized.
|
PIVC 20G, 1.75 Inch Length
One participant receives 2 Peripheral Intravenous Catheters (PIVC) with the same Gauge (20G), one in each arm.
The length of the catheter is different in each arm, in this case: 1.75 Inch.
Choice of catheter size and length is randomized per participant, as well as which arm is first catharized.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
19 19
|
19 19
|
21 21
|
21 21
|
|
Overall Study
COMPLETED
|
19 19
|
19 19
|
21 21
|
21 21
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Impact of PIVC Length and Gauge on Catheter Indwell Time
Baseline characteristics by cohort
| Measure |
Small Gauge
n=19 Participants
2 PIVCs of same gauge (22G) and different lengths
Peripheral Intravenous Catheter: Randomised controlled
|
Large Gauge
n=21 Participants
2 PIVCs of same gauge (20G) and different lengths
Peripheral Intravenous Catheter: Randomised controlled
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
27.58 years
STANDARD_DEVIATION 8.82 • n=5 Participants
|
32.76 years
STANDARD_DEVIATION 13.12 • n=7 Participants
|
30.3 years
STANDARD_DEVIATION 11.45 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian, White
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
19 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
BMI
|
25.09 kg/m^2
STANDARD_DEVIATION 3.65 • n=5 Participants
|
26.84 kg/m^2
STANDARD_DEVIATION 5.22 • n=7 Participants
|
26.01 kg/m^2
STANDARD_DEVIATION 4.57 • n=5 Participants
|
|
Recent use of analgesics
Recent use of analgetic
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Recent use of analgesics
No recent use of analgetic
|
13 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Systolic Blood Pressure
|
115.83 mm Hg
STANDARD_DEVIATION 10.75 • n=5 Participants
|
117.90 mm Hg
STANDARD_DEVIATION 10.02 • n=7 Participants
|
116.92 mm Hg
STANDARD_DEVIATION 10.29 • n=5 Participants
|
|
Diastolic Blood Pressure
|
76.42 mm Hg
STANDARD_DEVIATION 8.09 • n=5 Participants
|
76.71 mm Hg
STANDARD_DEVIATION 7.40 • n=7 Participants
|
76.58 mm Hg
STANDARD_DEVIATION 7.46 • n=5 Participants
|
|
O2 saturation
|
97.89 Percentage of oxygen in blood
STANDARD_DEVIATION 1.05 • n=5 Participants
|
97.71 Percentage of oxygen in blood
STANDARD_DEVIATION 1.23 • n=7 Participants
|
97.80 Percentage of oxygen in blood
STANDARD_DEVIATION 1.14 • n=5 Participants
|
PRIMARY outcome
Timeframe: 72 hrsPopulation: After screening and enrollment, participants will be randomized in order of their enrollment to either 20 or 22G of the BD NexivaTM PIVC and order of placement location (left or right arm first). The participant will have both the 1 inch and 1.75 inch PIVCs inserted on Study Day 1 (Visit 2), one into each arm. After successful insertion into the lower cephalic vein of the selected arm, the site will be regularly accessed (twice daily) for phlebotomy and then flushed.
Catheter indwell time for each PIVC, expressed in hours
Outcome measures
| Measure |
PIVC 22G, 1 Inch Length
n=19 Participants
small gauge, shorter catheter
|
PIVC 22G, 1.75 Inch Length
n=19 Participants
small gauge, longer catheter
|
PIVC 20G, 1 Inch Length
n=21 Participants
large gauge, smaller catheter
|
PIVC 20G, 1.75 Inch Length
n=21 Participants
large gauge, larger catheter
|
|---|---|---|---|---|
|
Patent Indwell Time Between PIVCs of Different Length and Gauge.
|
40.19 hours
Standard Deviation 25.34
|
42.96 hours
Standard Deviation 22.04
|
35.91 hours
Standard Deviation 25.55
|
36.91 hours
Standard Deviation 21.36
|
SECONDARY outcome
Timeframe: 72 hrsHaemolysis: Frequency of occurrence
Outcome measures
| Measure |
PIVC 22G, 1 Inch Length
n=19 Participants
small gauge, shorter catheter
|
PIVC 22G, 1.75 Inch Length
n=19 arms
small gauge, longer catheter
|
PIVC 20G, 1 Inch Length
n=21 arms
large gauge, smaller catheter
|
PIVC 20G, 1.75 Inch Length
n=21 arms
large gauge, larger catheter
|
|---|---|---|---|---|
|
Number of Participants With Haemolysis Occurrence Based on Blood Collection Device and Catheter Device Configuration
Visual haemolysis, 2 mL collection tube
|
0 arms
|
0 arms
|
0 arms
|
0 arms
|
|
Number of Participants With Haemolysis Occurrence Based on Blood Collection Device and Catheter Device Configuration
Visual haemolysis, 6 mL collection tube
|
0 arms
|
0 arms
|
0 arms
|
0 arms
|
Adverse Events
PIVC 22G, 1 Inch Length
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
PIVC 22G, 1.75 Inch Length
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
PIVC 20G, 1 Inch Length
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
PIVC 20G, 1.75 Inch Length
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PIVC 22G, 1 Inch Length
n=19 participants at risk
Adverse Events are presented for all participants within the group of participants receiving the small gauge catheter of 22G, for 1 Inch catheter length.
|
PIVC 22G, 1.75 Inch Length
n=19 participants at risk；n=21 participants at risk
Adverse Events are presented for all participants within the group of participants receiving the large gauge catheter of 22G, for 1.75 Inch catheter length.
|
PIVC 20G, 1 Inch Length
n=21 participants at risk
Adverse Events are presented for all participants within the group of participants receiving the large gauge catheter of 20G, for 1 Inch catheter length.
|
PIVC 20G, 1.75 Inch Length
n=21 participants at risk
Adverse Events are presented for all participants within the group of participants receiving the large gauge catheter of 20G, for 1.75 Inch catheter length.
|
|---|---|---|---|---|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/19 • Adverse Events are collected from time of enrollment until catheter removal (max 72 hours indwell time)
Adverse Events are systematically collected during the study visits and a Clinical Research Associate actively reviewed the patient medical records for any occurred events.
|
5.3%
1/19 • Number of events 1 • Adverse Events are collected from time of enrollment until catheter removal (max 72 hours indwell time)
Adverse Events are systematically collected during the study visits and a Clinical Research Associate actively reviewed the patient medical records for any occurred events.
|
9.5%
2/21 • Number of events 2 • Adverse Events are collected from time of enrollment until catheter removal (max 72 hours indwell time)
Adverse Events are systematically collected during the study visits and a Clinical Research Associate actively reviewed the patient medical records for any occurred events.
|
9.5%
2/21 • Number of events 2 • Adverse Events are collected from time of enrollment until catheter removal (max 72 hours indwell time)
Adverse Events are systematically collected during the study visits and a Clinical Research Associate actively reviewed the patient medical records for any occurred events.
|
|
General disorders
Inflammatory pain
|
5.3%
1/19 • Number of events 1 • Adverse Events are collected from time of enrollment until catheter removal (max 72 hours indwell time)
Adverse Events are systematically collected during the study visits and a Clinical Research Associate actively reviewed the patient medical records for any occurred events.
|
0.00%
0/19 • Adverse Events are collected from time of enrollment until catheter removal (max 72 hours indwell time)
Adverse Events are systematically collected during the study visits and a Clinical Research Associate actively reviewed the patient medical records for any occurred events.
|
4.8%
1/21 • Number of events 1 • Adverse Events are collected from time of enrollment until catheter removal (max 72 hours indwell time)
Adverse Events are systematically collected during the study visits and a Clinical Research Associate actively reviewed the patient medical records for any occurred events.
|
14.3%
3/21 • Number of events 3 • Adverse Events are collected from time of enrollment until catheter removal (max 72 hours indwell time)
Adverse Events are systematically collected during the study visits and a Clinical Research Associate actively reviewed the patient medical records for any occurred events.
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/19 • Adverse Events are collected from time of enrollment until catheter removal (max 72 hours indwell time)
Adverse Events are systematically collected during the study visits and a Clinical Research Associate actively reviewed the patient medical records for any occurred events.
|
0.00%
0/19 • Adverse Events are collected from time of enrollment until catheter removal (max 72 hours indwell time)
Adverse Events are systematically collected during the study visits and a Clinical Research Associate actively reviewed the patient medical records for any occurred events.
|
9.5%
2/21 • Number of events 2 • Adverse Events are collected from time of enrollment until catheter removal (max 72 hours indwell time)
Adverse Events are systematically collected during the study visits and a Clinical Research Associate actively reviewed the patient medical records for any occurred events.
|
4.8%
1/21 • Number of events 1 • Adverse Events are collected from time of enrollment until catheter removal (max 72 hours indwell time)
Adverse Events are systematically collected during the study visits and a Clinical Research Associate actively reviewed the patient medical records for any occurred events.
|
|
Nervous system disorders
Syncope
|
0.00%
0/19 • Adverse Events are collected from time of enrollment until catheter removal (max 72 hours indwell time)
Adverse Events are systematically collected during the study visits and a Clinical Research Associate actively reviewed the patient medical records for any occurred events.
|
0.00%
0/19 • Adverse Events are collected from time of enrollment until catheter removal (max 72 hours indwell time)
Adverse Events are systematically collected during the study visits and a Clinical Research Associate actively reviewed the patient medical records for any occurred events.
|
4.8%
1/21 • Number of events 1 • Adverse Events are collected from time of enrollment until catheter removal (max 72 hours indwell time)
Adverse Events are systematically collected during the study visits and a Clinical Research Associate actively reviewed the patient medical records for any occurred events.
|
0.00%
0/21 • Adverse Events are collected from time of enrollment until catheter removal (max 72 hours indwell time)
Adverse Events are systematically collected during the study visits and a Clinical Research Associate actively reviewed the patient medical records for any occurred events.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/19 • Adverse Events are collected from time of enrollment until catheter removal (max 72 hours indwell time)
Adverse Events are systematically collected during the study visits and a Clinical Research Associate actively reviewed the patient medical records for any occurred events.
|
0.00%
0/19 • Adverse Events are collected from time of enrollment until catheter removal (max 72 hours indwell time)
Adverse Events are systematically collected during the study visits and a Clinical Research Associate actively reviewed the patient medical records for any occurred events.
|
0.00%
0/21 • Adverse Events are collected from time of enrollment until catheter removal (max 72 hours indwell time)
Adverse Events are systematically collected during the study visits and a Clinical Research Associate actively reviewed the patient medical records for any occurred events.
|
4.8%
1/21 • Number of events 1 • Adverse Events are collected from time of enrollment until catheter removal (max 72 hours indwell time)
Adverse Events are systematically collected during the study visits and a Clinical Research Associate actively reviewed the patient medical records for any occurred events.
|
|
General disorders
Injection site extravasation
|
0.00%
0/19 • Adverse Events are collected from time of enrollment until catheter removal (max 72 hours indwell time)
Adverse Events are systematically collected during the study visits and a Clinical Research Associate actively reviewed the patient medical records for any occurred events.
|
0.00%
0/19 • Adverse Events are collected from time of enrollment until catheter removal (max 72 hours indwell time)
Adverse Events are systematically collected during the study visits and a Clinical Research Associate actively reviewed the patient medical records for any occurred events.
|
19.0%
4/21 • Number of events 4 • Adverse Events are collected from time of enrollment until catheter removal (max 72 hours indwell time)
Adverse Events are systematically collected during the study visits and a Clinical Research Associate actively reviewed the patient medical records for any occurred events.
|
0.00%
0/21 • Adverse Events are collected from time of enrollment until catheter removal (max 72 hours indwell time)
Adverse Events are systematically collected during the study visits and a Clinical Research Associate actively reviewed the patient medical records for any occurred events.
|
|
General disorders
Injection site haematoma
|
0.00%
0/19 • Adverse Events are collected from time of enrollment until catheter removal (max 72 hours indwell time)
Adverse Events are systematically collected during the study visits and a Clinical Research Associate actively reviewed the patient medical records for any occurred events.
|
0.00%
0/19 • Adverse Events are collected from time of enrollment until catheter removal (max 72 hours indwell time)
Adverse Events are systematically collected during the study visits and a Clinical Research Associate actively reviewed the patient medical records for any occurred events.
|
9.5%
2/21 • Number of events 2 • Adverse Events are collected from time of enrollment until catheter removal (max 72 hours indwell time)
Adverse Events are systematically collected during the study visits and a Clinical Research Associate actively reviewed the patient medical records for any occurred events.
|
0.00%
0/21 • Adverse Events are collected from time of enrollment until catheter removal (max 72 hours indwell time)
Adverse Events are systematically collected during the study visits and a Clinical Research Associate actively reviewed the patient medical records for any occurred events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/19 • Adverse Events are collected from time of enrollment until catheter removal (max 72 hours indwell time)
Adverse Events are systematically collected during the study visits and a Clinical Research Associate actively reviewed the patient medical records for any occurred events.
|
0.00%
0/19 • Adverse Events are collected from time of enrollment until catheter removal (max 72 hours indwell time)
Adverse Events are systematically collected during the study visits and a Clinical Research Associate actively reviewed the patient medical records for any occurred events.
|
0.00%
0/21 • Adverse Events are collected from time of enrollment until catheter removal (max 72 hours indwell time)
Adverse Events are systematically collected during the study visits and a Clinical Research Associate actively reviewed the patient medical records for any occurred events.
|
4.8%
1/21 • Number of events 1 • Adverse Events are collected from time of enrollment until catheter removal (max 72 hours indwell time)
Adverse Events are systematically collected during the study visits and a Clinical Research Associate actively reviewed the patient medical records for any occurred events.
|
Additional Information
Christopher Rini, Associate Director Translational and Clinical Sciences Center of Excellence
Becton, Dickinson and Company
Phone: +1 984 389 1186
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place