Vascular Access ComplicationNCT05165784
Comparison of Techniques in Determining Femoral Veins Location
A study testing femoral vein identification in people with Vascular Access Complication, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
This study aimed to determine the accuracy of the V technique in predicting the location of the femoral vein compared to the technique of palpating the femoral artery with the use of USGss as a standard in determining the exact location of the femoral vein. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Vascular Access Complication
- What is being tested?
- femoral vein identification
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteIndonesia
- Study dates
- 10 Feb 2020to 15 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients aged 18-65 years
- body mass index (BMI) of 18-25 kg/m2
Who cannot join
- could not lie supine
- had congenital or acquired abnormalities in the pelvic and inguinal region
- had a history of previous femoral vein puncture
- allergic to USG gel
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Cipto Mangunkusumo Cental National Hospital
Jakarta, DKI Jakarta, 10430
About this study
Official title: Comparison of the Accuracy Between Technique V and Arterial Palpation Techniques in Determining the Location of the Femoral Veins
This study aimed to determine the accuracy of the V technique in predicting the location of the femoral vein compared to the technique of palpating the femoral artery with the use of USGss as a standard in determining the exact location of the femoral vein.
Read the detailed description
One hundred and fifteen subjects were allocated into two large groups, V tecnique group and palpation tecnique group. Researchers will perform the V technique on the patient's inguinal area. This technique was performed using the researcher's contralateral hand. After the V technique is performed, the next researcher will perform the technique of palpating the femoral artery pulse at the exact location as the V technique. This technique is done by palpating the femoral artery pulsation using the examiner's index and middle fingers along the inguinal ligament; the location of the femoral vein is at 1 cm. medial to the femoral artery 2 cm inferior to the inguinal ligament. This location is marked "y" with a UV marker. researchers will compare the accuracy of both techniques in determining the exact location of femoral veins.
- Conditions
- Vascular Access Complication
- Being tested
- femoral vein identification
- Keywords
- arterial palpation technique, femoral access, femoral vein, V tecnique, vascular access
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
femoral vein identificationProcedure or surgery
Femoral vein identification using V technique
femoral vein identificationProcedure or surgery
Femoral vein identification using palpation technique
| Study group | Role | What they receive |
|---|---|---|
| V technique | Active comparator | Researcher will perform the V tecnique on the patient's inguinal area Receives: Procedure: femoral vein identification |
| palpation tecnique | Active comparator | Researcher will perform the V tecnique on the patient's inguinal area Receives: Procedure: femoral vein identification |
What is being measured
The primary outcome is the main question the study is designed to answer.
prediction of femoral vein location
Researcher will identify femoral vein location
Measured: intra procedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2021
- Study start10 Feb 2020
- Primary completion20 Mar 2020
- Study completion15 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular Access ComplicationStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aida Rosita Tantri, Universitas Indonesia
- Investigators
- Aida Rosita R Tantri, Doctor, Principal investigator, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05165784
- Sponsor's protocol ID
- IndonesiaUAnes123
- Status last verified
- Dec 2021
- First submitted
- 8 Dec 2021
- Last updated
- 21 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Accuracy Between Technique V and Arterial Palpation Techniques in Determining the Location of the Femoral Veins
- ClinicalTrials.gov ID
- NCT05165784
- Acronym / sponsor ID
- IndonesiaUAnes123
- Conditions
- Vascular Access Complication
- Keywords
- arterial palpation technique, femoral access, femoral vein, V tecnique, vascular access
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 10 Feb 2020 (actual)
- Primary completion
- 20 Mar 2020 (actual)
- Study completion
- 15 Jun 2020 (actual)
- First posted
- 21 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aimed to determine the accuracy of the V technique in predicting the location of the femoral vein compared to the technique of palpating the femoral artery with the use of USGss as a standard in determining the exact location of the femoral vein.
Detailed description
One hundred and fifteen subjects were allocated into two large groups, V tecnique group and palpation tecnique group. Researchers will perform the V technique on the patient's inguinal area. This technique was performed using the researcher's contralateral hand. After the V technique is performed, the next researcher will perform the technique of palpating the femoral artery pulse at the exact location as the V technique. This technique is done by palpating the femoral artery pulsation using the examiner's index and middle fingers along the inguinal ligament; the location of the femoral vein is at 1 cm. medial to the femoral artery 2 cm inferior to the inguinal ligament. This location is marked "y" with a UV marker. researchers will compare the accuracy of both techniques in determining the exact location of femoral veins.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| V technique | Active comparator | Procedure: femoral vein identificationResearcher will perform the V tecnique on the patient's inguinal area |
| palpation tecnique | Active comparator | Procedure: femoral vein identificationResearcher will perform the V tecnique on the patient's inguinal area |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients aged 18-65 years
- body mass index (BMI) of 18-25 kg/m2
Key exclusion criteria (4 listed)
- could not lie supine
- had congenital or acquired abnormalities in the pelvic and inguinal region
- had a history of previous femoral vein puncture
- allergic to USG gel
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| femoral vein identificationFemoral vein identification using V technique | Procedure or surgery | V technique, palpation tecnique |
| femoral vein identificationFemoral vein identification using palpation technique | Procedure or surgery | V technique, palpation tecnique |
Primary outcome
prediction of femoral vein location
Time frame: intra procedural
Researcher will identify femoral vein location
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aida Rosita R Tantri, Doctor principal investigator
Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing femoral vein identification in people with Vascular Access Complication, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prediction of femoral vein location (time frame: intra procedural). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2021.