NCT05310864

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2019

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2019

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

March 14, 2022

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 5, 2022

Completed
Last Updated

April 5, 2022

Status Verified

March 1, 2022

Enrollment Period

29 days

First QC Date

March 14, 2022

Last Update Submit

March 26, 2022

Conditions

Femoral Artery and Vein DistanceAnatomic

Keywords

femoral arteryfemoral veinultrasonographyFrog leg positionabduction-exorotation position

Outcome Measures

Primary Outcomes (1)

  • 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

    one day at diagnosis day

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cipto Mangunkusumo Central National Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

Study Officials

  • Aldy Heriwardito, Doctor

    Indonesia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 14, 2022

First Posted

April 5, 2022

Study Start

April 1, 2019

Primary Completion

April 30, 2019

Study Completion

April 30, 2019

Last Updated

April 5, 2022

Record last verified: 2022-03

Locations

ID(1)