Effect of a Sacral Lift on Femoral Vein Size and Exposure

NCT ID: NCT06916741

Last Updated: 2025-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-23

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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This study is a clinical trial designed to investigate the effectiveness of a sacral lift in improving femoral vein size and exposure. If a sacral lift improves femoral vein size and/or exposure, it may improve the success rate of femoral vein cannulation, a critical resuscitative procedure. Femoral vein cannulation can be difficult when the vein is overlapped by the femoral artery. While positioning the leg in abduction with external rotation and knee flexion ("frog-leg" position) is known to improve femoral vein exposure, this study explores the potential added benefit of a sacral lift (a gel pad placed under the sacrum). The study will focus on emergency department patients who frequently require this procedure.

The primary purpose is to determine if the addition of a sacral lift improves femoral vein size and exposure, thereby potentially facilitating easier and more successful cannulation. The study will address the following key questions:

Does the use of a sacral lift significantly increase femoral vein diameter compared to no sacral lift, in both straight leg and frog-leg positions?

Does the use of a sacral lift significantly improve the visualization of the femoral vein (reduce femoral artery overlap) compared to no sacral lift, in both straight leg and frog-leg positions?

The study will employ a comparative design, measuring femoral vein size and assessing the degree of femoral artery overlap with and without a sacral lift, in both straight leg and frog-leg positions. This will allow researchers to directly compare the impact of the sacral lift on these critical factors affecting cannulation success. The findings will provide valuable data for optimizing the technique of femoral vein cannulation and improving outcomes in critically ill patients.

Conditions

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Femoral Artery Cannulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Sacral Lift First

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

Group Type EXPERIMENTAL

Ultrasound with Sacral lift

Intervention Type DIAGNOSTIC_TEST

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

Sacral Lift Second

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

Group Type EXPERIMENTAL

Ultrasound with Sacral lift

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Ultrasound with Sacral lift

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Adult emergency department patients.

Exclusion Criteria

* \<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). If 100% of the femoral vein is already exposed from under the femoral artery with a straight leg (right or left), the patient will be excluded from the study.
* Vulnerable populations such as pregnant women and those who cannot consent.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

OTHER

Sponsor Role lead

Responsible Party

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Dr. Dhimitri Nikolla

EM Core Faculty / Research Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

Allegheny Health Network

Locations

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Saint Vincent Hospital

Erie, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Dhimitri Nikolla, DO, MS, FACEP, FACOEP

Role: CONTACT

(845) 325-8985

AHN Clinical Trials Contact

Role: CONTACT

Facility Contacts

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Dhimitri Nikolla, DO, MS, FACEP, FACOEP

Role: primary

(845) 325-8985

AHN Clinical Trials Contact

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 16567260 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22025941 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18211323 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19317705 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19372327 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17976787 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30735284 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22862758 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24725821 (View on PubMed)

Castro D, Martin Lee LM, Bhutta BS. Femoral Vein Central Venous Access(Archived). 2023 Aug 17. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK459255/

Reference Type BACKGROUND
PMID: 29083581 (View on PubMed)

Other Identifiers

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Sacral Lift

Identifier Type: -

Identifier Source: org_study_id

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