Comparison of the Distance Between the Femoral Artery and Veins in Various Position in Malay Race Adult

March 26, 2022 updated by: Aldy Heriwardito

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.

Study Overview

Status

Completed

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 Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • DKI Jakarta
      • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
        • Cipto Mangunkusumo Central National Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All Malay race adult seeking for medication in Ciptomangunkusumo Hospital who agree to participate in the study

Description

Inclusion Criteria:

  1. Malay race adult 18-60 years old
  2. Agree to participate in the study and undergoing femoral vein cannulation
  3. Normal weight with IMT 19-25 kg/m2

Exclusion Criteria:

  1. Previous cannulation on the same vein
  2. Femoral vein catheter has been placed
  3. Anatomical variation (artery-venous malformation, venous or artery branch at 2 cm inferior to inguinal ligament)
  4. Abdominal distention
  5. Femoral vein thrombosis
  6. Hypotension (Mean Arterial Pressure <65 mmHg, or using vasopressor or inotrope)

Drop out Criteria:

  1. Anatomical abnormalities of femoral vein or artery visualized using ultrasonography examination
  2. Fail to visualize femoral vein or artery using ultrasonography for two minutes, operated by trained personnel and declared competent by cardiovascular anesthesiologist consultant
  3. Patient not cooperative during procedure, hence, unable to maintain limb position for more than 2 minutes in any position examined
  4. Patients with right femur fracture

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
one day at diagnosis day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Aldy Heriwardito, Doctor, Indonesia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2019

Primary Completion (Actual)

April 30, 2019

Study Completion (Actual)

April 30, 2019

Study Registration Dates

First Submitted

March 14, 2022

First Submitted That Met QC Criteria

March 26, 2022

First Posted (Actual)

April 5, 2022

Study Record Updates

Last Update Posted (Actual)

April 5, 2022

Last Update Submitted That Met QC Criteria

March 26, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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