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Completed

NCT Number: NCT05310864

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

The purpose of this study is to compare the distance between femoral artery and vein in frog position, abduction-exorotation position and anatomical position.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cipto Mangunkusumo Central National Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

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

Treatment and study plan

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Aldy Heriwardito

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 5, 2022
Registry last updated
Apr 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.