Clinical trial NCT05310864: Comparison of the Distance Between the Femoral Artery and Veins in Various Position in Malay Race Adult
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Femoral Artery and Vein Distance
Anatomic
Keywords: femoral artery
femoral vein
ultrasonography
Frog leg position
abduction-exorotation position
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2022-04-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All Malay race adult seeking for medication in Ciptomangunkusumo Hospital who agree to participate in the study

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The distance between femoral vein and artery in millimeter
timeFrame: one day at diagnosis day
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Cipto Mangunkusumo Central National Hospital
state: DKI Jakarta
Study officials:
affiliation: Indonesia University
name: Aldy Heriwardito, Doctor
role: PRINCIPAL_INVESTIGATOR
References: