Trial Outcomes & Findings for Femoral Central Venous Access Comparison of 2 Methods (NCT NCT02318940)
NCT ID: NCT02318940
Last Updated: 2017-03-30
Results Overview
Percentage of Participants with successful installation on the first transcutaneous passage of the glass needle
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
99 participants
Primary outcome timeframe
intraoperative, an average of 1 hour
Results posted on
2017-03-30
Participant Flow
Participant milestones
| Measure |
Landmark Method
installation of Central venous catheter In this arm the catheter will be installed under the usual method guided by anatomical landmarks.
access will be through the femoral vein only
central venous catheter: installation of Central venous catheter landmark guided
|
Ultrasound Method
installation of Central venous catheter This arm of the catheter is installed using real-time ultrasound. Access will be through the femoral vein only
central venous catheter: installation of Central venous catheter ultrasound guided
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
49
|
50
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Landmark Method
installation of Central venous catheter In this arm the catheter will be installed under the usual method guided by anatomical landmarks.
access will be through the femoral vein only
central venous catheter: installation of Central venous catheter landmark guided
|
Ultrasound Method
installation of Central venous catheter This arm of the catheter is installed using real-time ultrasound. Access will be through the femoral vein only
central venous catheter: installation of Central venous catheter ultrasound guided
|
|---|---|---|
|
Overall Study
lost the record
|
1
|
0
|
Baseline Characteristics
Femoral Central Venous Access Comparison of 2 Methods
Baseline characteristics by cohort
| Measure |
Landmark Method
n=49 Participants
installation of Central venous catheter In this arm the catheter will be installed under the usual method guided by anatomical landmarks.
access will be through the femoral vein only
central venous catheter: installation of Central venous catheter landmark guided
|
Ultrasound Method
n=50 Participants
installation of Central venous catheter This arm of the catheter is installed using real-time ultrasound. Access will be through the femoral vein only
central venous catheter: installation of Central venous catheter ultrasound guided
|
Total
n=99 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
12 months
n=5 Participants
|
14 months
n=7 Participants
|
13 months
n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
weight
|
10 kg
n=5 Participants
|
9 kg
n=7 Participants
|
10 kg
n=5 Participants
|
PRIMARY outcome
Timeframe: intraoperative, an average of 1 hourPercentage of Participants with successful installation on the first transcutaneous passage of the glass needle
Outcome measures
| Measure |
Landmark Method
n=49 Participants
installation of Central venous catheter In this arm the catheter will be installed under the usual method guided by anatomical landmarks.
access will be through the femoral vein only
central venous catheter: installation of Central venous catheter landmark guided
|
Ultrasound Method
n=50 Participants
installation of Central venous catheter This arm of the catheter is installed using real-time ultrasound. Access will be through the femoral vein only
central venous catheter: installation of Central venous catheter ultrasound guided
|
|---|---|---|
|
Installation on the First Try
|
18 percentage of participants
|
42 percentage of participants
|
SECONDARY outcome
Timeframe: intraoperative, an average of 1 hourPercentage of participants with successful installation of guide without difficulty in the femoral vein
Outcome measures
| Measure |
Landmark Method
n=49 Participants
installation of Central venous catheter In this arm the catheter will be installed under the usual method guided by anatomical landmarks.
access will be through the femoral vein only
central venous catheter: installation of Central venous catheter landmark guided
|
Ultrasound Method
n=50 Participants
installation of Central venous catheter This arm of the catheter is installed using real-time ultrasound. Access will be through the femoral vein only
central venous catheter: installation of Central venous catheter ultrasound guided
|
|---|---|---|
|
Successful Installation
|
51 percentage of participants
|
84 percentage of participants
|
SECONDARY outcome
Timeframe: intraoperative, an average of 1 hourNumber of participants who succeeded in the installation of cvc in one, two, three, four or five attempts.
Outcome measures
| Measure |
Landmark Method
n=49 Participants
installation of Central venous catheter In this arm the catheter will be installed under the usual method guided by anatomical landmarks.
access will be through the femoral vein only
central venous catheter: installation of Central venous catheter landmark guided
|
Ultrasound Method
n=50 Participants
installation of Central venous catheter This arm of the catheter is installed using real-time ultrasound. Access will be through the femoral vein only
central venous catheter: installation of Central venous catheter ultrasound guided
|
|---|---|---|
|
Number of Attempts
first attempt
|
9 participants
|
21 participants
|
|
Number of Attempts
second attempt
|
4 participants
|
18 participants
|
|
Number of Attempts
third attempt
|
6 participants
|
4 participants
|
|
Number of Attempts
fourth attempt
|
2 participants
|
0 participants
|
|
Number of Attempts
fifth attempt
|
4 participants
|
0 participants
|
|
Number of Attempts
Unsuccessful cannulation
|
24 participants
|
7 participants
|
SECONDARY outcome
Timeframe: intraoperative, an average of 1 hourPercentage of participants with Arterial puncture aspiration
Outcome measures
| Measure |
Landmark Method
n=49 Participants
installation of Central venous catheter In this arm the catheter will be installed under the usual method guided by anatomical landmarks.
access will be through the femoral vein only
central venous catheter: installation of Central venous catheter landmark guided
|
Ultrasound Method
n=50 Participants
installation of Central venous catheter This arm of the catheter is installed using real-time ultrasound. Access will be through the femoral vein only
central venous catheter: installation of Central venous catheter ultrasound guided
|
|---|---|---|
|
Arterial Puncture
|
25 percentage of participants
|
10 percentage of participants
|
Adverse Events
Landmark Method
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ultrasound Method
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