Effect of a Sacral Lift on Femoral Vein Size and Exposure

NCT06916741 | Recruiting

• 1 other identifier: Sacral Lift
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if a sacral lift can improve femoral vein size and exposure, which may be clinically helpful during femoral vein cannulation among emergency department patients. The main questions it aims to answer are: Does a sacral lift increase femoral vein size compared to no sacral lift in both straight and frog-leg positions? Does a sacral lift improve femoral vein exposure (reduce overlap by the femoral artery) compared to no sacral lift in both straight and frog-leg positions? Researchers will compare femoral vein size and exposure measurements with and without a sacral lift in both straight and frog-leg leg positions to see if the sacral lift improves vein size and reduces artery overlap. Participants will: Undergo femoral vein ultrasound scans. Maintain a straight leg position with and without a sacral lift. Maintain a frog-leg position with and without a sacral lift.

Conditions

Femoral Artery; Cannulation

Keywords

femoral artery; ultrasound; femoral vein; sacral lift; cannulation

Outcome Measures

Primary Outcomes (1)

• Potential effect of a sacral lift on femoral vein cross-sectional area

  Our objective is to use ultrasound measurements to compare femoral vein cross-sectional area in centimeters squared (cm\^2) within each subject with and without a sacral lift.

  From enrollment to end of ultrasound measurements, expected to take up to one hour

Secondary Outcomes (3)

• Potential effect of a sacral lift on measurements of femoral vein diameter

  From enrollment to end of ultrasound measurements, expected to take up to one hour

• Potential effect of a sacral lift on measurements of femoral vein exposure

  From enrollment to end of ultrasound measurements, expected to take up to one hour

• Potential effect of a sacral lift on measurements of femoral vein depth

  From enrollment to end of ultrasound measurements, expected to take up to one hour

Study Arms (2)

Sacral Lift First

EXPERIMENTAL

Femoral vein measurements are first collected using a sacral lift, then collected again without using a sacral lift.

Diagnostic Test: Ultrasound with Sacral lift

Sacral Lift Second

EXPERIMENTAL

Femoral vein measurements are first collected without using a sacral lift, then collected again using a sacral lift.

Diagnostic Test: Ultrasound with Sacral lift

Interventions

Ultrasound with Sacral lift DIAGNOSTIC_TEST

Intervention includes using a sacral lift during ultrasound to collect femoral vein measurements.

Sacral Lift First; Sacral Lift Second

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult emergency department patients.

You may not qualify if:

• \<18 or \>85 years-old
• Anyone with a history of: deep venous thrombosis (DVT), May-Thurner syndrome, lower extremity vein harvesting, arterial or venous surgery of the lower leg (e.g., peripheral arterial stent placement or sclerotherapy of lower extremity varicose veins), or peripheral vascular disease.
• Anyone with a medical condition that could impact their physical ability to lay supine or abduct and externally rotate their hips safely (e.g., hip fracture).
• Anyone whose femoral vessels cannot be clearly identified using a linear transducer
• Anyone whose femoral vein is not compressible on the study ultrasound (indicating a DVT).
• Vulnerable populations such as pregnant women and those who cannot consent.

Sponsors & Collaborators

• Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute): lead

Study Sites (1)

Saint Vincent Hospital

Erie, Pennsylvania, 16544, United States

RECRUITING

Related Publications (10)

• Stone MB, Price DD, Anderson BS. Ultrasonographic investigation of the effect of reverse Trendelenburg on the cross-sectional area of the femoral vein. J Emerg Med. 2006 Feb;30(2):211-3. doi: 10.1016/j.jemermed.2005.05.022.

  PMID: 16567260 BACKGROUND

• Kim W, Chung RK, Lee GY, Han JI. The effects of hip abduction with external rotation and reverse Trendelenburg position on the size of the femoral vein; ultrasonographic investigation. Korean J Anesthesiol. 2011 Sep;61(3):205-9. doi: 10.4097/kjae.2011.61.3.205. Epub 2011 Sep 23.

  PMID: 22025941 BACKGROUND

• Kim JT, Lee NJ, Na HS, Jeon Y, Kim HS, Kim CS, Kim SD. Ultrasonographic investigation of the effect of inguinal compression on the cross-sectional area of the femoral vein. Acad Emerg Med. 2008 Jan;15(1):101-3. doi: 10.1111/j.1553-2712.2007.00018.x.

  PMID: 18211323 BACKGROUND

• Suk EH, Kim DH, Kil HK, Kweon TD. Effects of reverse Trendelenburg position and inguinal compression on femoral vein cross-sectional area in infants and young children. Anaesthesia. 2009 Apr;64(4):399-402. doi: 10.1111/j.1365-2044.2008.05815.x.

  PMID: 19317705 BACKGROUND

• Kim JT, Park CS, Kim HJ, Lee JM, Kim HS, Kim CS, Kim SD. The effect of inguinal compression, Valsalva maneuver, and reverse Trendelenburg position on the cross-sectional area of the femoral vein in children. Anesth Analg. 2009 May;108(5):1493-6. doi: 10.1213/ane.0b013e31819bccc7.

  PMID: 19372327 BACKGROUND

• Werner SL, Jones RA, Emerman CL. Effect of hip abduction and external rotation on femoral vein exposure for possible cannulation. J Emerg Med. 2008 Jul;35(1):73-5. doi: 10.1016/j.jemermed.2007.03.023. Epub 2007 Aug 29.

  PMID: 17976787 BACKGROUND

• Ahn JH, Park J, Song IS, Kim KA, Park J, Min JJ, Kim CS, Lee JH. The angle range of leg abduction with external hip rotation which can minimize femoral artery and vein overlap in pediatric patients. Paediatr Anaesth. 2019 Apr;29(4):361-367. doi: 10.1111/pan.13603. Epub 2019 Mar 21.

  PMID: 30735284 BACKGROUND

• Read H, Holdgate A, Watkins S. Simple external rotation of the leg increases the size and accessibility of the femoral vein. Emerg Med Australas. 2012 Aug;24(4):408-13. doi: 10.1111/j.1742-6723.2012.01568.x. Epub 2012 Apr 25.

  PMID: 22862758 BACKGROUND

• Randall C, Schmeiser E, Fiers E, Little A, Dogbey G, Richardson G. Ultrasound investigation of leg position to enhance femoral vein exposure for cannulation. J Emerg Med. 2014 Aug;47(2):176-81. doi: 10.1016/j.jemermed.2014.02.001. Epub 2014 Apr 13.

  PMID: 24725821 BACKGROUND

• Castro D, Martin Lee LM, Bhutta BS. Femoral Vein Central Venous Access(Archived). 2023 Aug 17. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK459255/

  PMID: 29083581 BACKGROUND

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Principal Investigator Dhimitri Nikolla, DO, MS, FACEP, FACOEP

  Allegheny Health Network

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dhimitri Nikolla, DO, MS, FACEP, FACOEP

CONTACT

(845) 325-8985; dhimitri.nikolla@med.lecom.edu

AHN Clinical Trials Contact

CONTACT

clinicaltrials@ahn.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: EM Core Faculty / Research Director

Model Details: The study design is a single-blinded, randomized (nested randomization of leg position and sacral lift sequence within randomized leg sequence \[i.e., left, right\]) cross-over study.

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: April 8, 2025
• Study Start: July 23, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)