Femoral Artery and Vein DistanceNCT05310864
Comparison of the Distance Between the Femoral Artery and Veins in Various Position in Malay Race Adult
An observational study of Femoral Artery and Vein Distance and Anatomic, run by Aldy Heriwardito at 1 site in Indonesia.
Trial summary
The purpose of this study is to compare the distance between femoral artery and vein in frog position, abduction-exorotation position and anatomical position. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Femoral Artery and Vein Distance, Anatomic
- How many people
- 50 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Apr 2019to 30 Apr 2019
- Phase
- Observational
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: All Malay race adult seeking for medication in Ciptomangunkusumo Hospital who agree to participate in the study
Who may be able to join
- Malay race adult 18-60 years old
- Agree to participate in the study and undergoing femoral vein cannulation
- Normal weight with IMT 19-25 kg/m2
Who cannot join
- Previous cannulation on the same vein
- Femoral vein catheter has been placed
- Anatomical variation (artery-venous malformation, venous or artery branch at 2 cm inferior to inguinal ligament)
- Abdominal distention
- Femoral vein thrombosis
- Hypotension (Mean Arterial Pressure <65 mmHg, or using vasopressor or inotrope)
Show all 11Show fewer
- Drop out Criteria:
- Anatomical abnormalities of femoral vein or artery visualized using ultrasonography examination
- Fail to visualize femoral vein or artery using ultrasonography for two minutes, operated by trained personnel and declared competent by cardiovascular anesthesiologist consultant
- Patient not cooperative during procedure, hence, unable to maintain limb position for more than 2 minutes in any position examined
- Patients with right femur fracture
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Cipto Mangunkusumo Central National Hospital
Jakarta Pusat, DKI Jakarta, 10430
About this study
Official title: Comparison of the Distance Between the Femoral Artery and Veins in Anatomic Position, Abduction-exorotation and Lower Limb Flexion Position (Frog Leg Position): Observational Study Using Ultrasonography in Malay Race Adult in Indonesia
The purpose of this study is to compare the distance between femoral artery and vein in frog position, abduction-exorotation position and anatomical position.
Read the detailed description
The incidence of unintentional arterial puncture during cannulation of femoral vein was high(20-50%). The addition of knee flexion to abcudtion-exorotation position (frog position) have been shown to increase the cross sectional area of femoral vein. The purpose of this study is to compare the distance between femoral artery and vein in frog position, abduction-exorotation position and anatomical position.
This study is an analytical observational study with cross sectional design within one grup with repeated measurement. The distance between artery and vein was measured in three position. The measurement was taken twice for each position. First picture was taken by one operator and one ultrasonography for all patient. Then another operator measured the distances with caliper feature on the ultrasonograph.
- Conditions
- Femoral Artery and Vein Distance, Anatomic
- Keywords
- femoral artery, femoral vein, ultrasonography, Frog leg position, abduction-exorotation position
What is being measured
The primary outcome is the main question the study is designed to answer.
The distance between femoral vein and artery in millimeter
The distance between femoral vein and artery in frog leg position, abduction-exorotation position, and anatomical position
Measured: one day at diagnosis day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start1 Apr 2019
- Primary completion30 Apr 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral Artery and Vein DistanceStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aldy Heriwardito
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aldy Heriwardito, Universitas Indonesia
- Investigators
- Aldy Heriwardito, Doctor, Principal investigator, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05310864
- Sponsor's protocol ID
- IndonesiaUAnes395
- Status last verified
- Mar 2022
- First submitted
- 14 Mar 2022
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Distance Between the Femoral Artery and Veins in Anatomic Position, Abduction-exorotation and Lower Limb Flexion Position (Frog Leg Position): Observational Study Using Ultrasonography in Malay Race Adult in Indonesia
- ClinicalTrials.gov ID
- NCT05310864
- Acronym / sponsor ID
- IndonesiaUAnes395
- Conditions
- Femoral Artery and Vein Distance, Anatomic
- Keywords
- femoral artery, femoral vein, ultrasonography, Frog leg position, abduction-exorotation position
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Aldy HeriwarditoUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 5 Apr 2022 (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.
The purpose of this study is to compare the distance between femoral artery and vein in frog position, abduction-exorotation position and anatomical position.
Detailed description
The incidence of unintentional arterial puncture during cannulation of femoral vein was high(20-50%). The addition of knee flexion to abcudtion-exorotation position (frog position) have been shown to increase the cross sectional area of femoral vein. The purpose of this study is to compare the distance between femoral artery and vein in frog position, abduction-exorotation position and anatomical position.
This study is an analytical observational study with cross sectional design within one grup with repeated measurement. The distance between artery and vein was measured in three position. The measurement was taken twice for each position. First picture was taken by one operator and one ultrasonography for all patient. Then another operator measured the distances with caliper feature on the ultrasonograph.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- All Malay race adult seeking for medication in Ciptomangunkusumo Hospital who agree to participate in the study
Key inclusion criteria (3 listed)
- Malay race adult 18-60 years old
- Agree to participate in the study and undergoing femoral vein cannulation
- Normal weight with IMT 19-25 kg/m2
Key exclusion criteria (11 listed)
- Previous cannulation on the same vein
- Femoral vein catheter has been placed
- Anatomical variation (artery-venous malformation, venous or artery branch at 2 cm inferior to inguinal ligament)
- Abdominal distention
- Femoral vein thrombosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The distance between femoral vein and artery in millimeter
Time frame: one day at diagnosis day
The distance between femoral vein and artery in frog leg position, abduction-exorotation position, and anatomical position
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 5 Apr 2022.
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.
Aldy Heriwardito, 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?
An observational study of Femoral Artery and Vein Distance and Anatomic, run by Aldy Heriwardito 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 3 inclusion and 11 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 5 Apr 2022. 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?
The distance between femoral vein and artery in millimeter (time frame: one day at diagnosis day). 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 5 Apr 2022.