- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05310864
Comparison of the Distance Between the Femoral Artery and Veins in Various Position in Malay Race Adult
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 Overview
Status
Conditions
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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DKI Jakarta
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Jakarta Pusat, DKI Jakarta, Indonesia, 10430
- Cipto Mangunkusumo Central National Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
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
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The distance between femoral vein and artery in frog leg position, abduction-exorotation position, and anatomical position
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one day at diagnosis day
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Aldy Heriwardito, Doctor, Indonesia University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IndonesiaUAnes395
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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