Femoral ArterySacral LiftNCT06916741
Effect of a Sacral Lift on Femoral Vein Size and Exposure
A study testing Ultrasound with Sacral lift in people with Femoral Artery and Cannulation, run by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Femoral Artery, Cannulation
- What is being tested?
- Ultrasound with Sacral lift
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jul 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult emergency department patients.
Who cannot join
- <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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Examining the Effect of a Sacral Lift on Femoral Vein Size and Exposure in the Emergency Department
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.
Read more
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.
Read the detailed description
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
- Femoral Artery, Cannulation
- Being tested
- Ultrasound with Sacral lift
- Keywords
- femoral artery, ultrasound, femoral vein, sacral lift, cannulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound with Sacral liftDiagnostic test
Intervention includes using a sacral lift during ultrasound to collect femoral vein measurements.
| Study group | Role | What they receive |
|---|---|---|
| Sacral Lift First | Experimental | Femoral vein measurements are first collected using a sacral lift, then collected again without using a sacral lift. Receives: 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. Receives: Diagnostic Test: Ultrasound with Sacral lift |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Our objective is to use ultrasound measurements to compare femoral vein diameter (from the medial to lateral wall of the femoral vein) in centimeters between within each subject with and without a sacral lift.
Measured: 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
Our objective is to use ultrasound measurements to compare femoral vein exposure (proportion of the width of the femoral vein not overlapped by the femoral artery: width of femoral vein in centimeters - width of femoral vein overlapped by femoral artery in centimeters / width of femoral vein in centimeters *100) between within each subject with and without a sacral lift.
Measured: 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
Our objective is to use ultrasound measurements to compare femoral vein depth (from skin to most superficial wall) in centimeters between within each subject with and without a sacral lift.
Measured: From enrollment to end of ultrasound measurements, expected to take up to one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start23 Jul 2025
- Primary completion14 May 2026
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Femoral ArteryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Dhimitri Nikolla, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
- Investigators
- Principal Investigator Dhimitri Nikolla, DO, MS, FACEP, FACOEP, Principal investigator, Allegheny Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06916741
- Sponsor's protocol ID
- Sacral Lift
- Acronym
- Sacral Lift
- Status last verified
- May 2026
- First submitted
- 20 Feb 2025
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It is not necessary for the scope of the study to share IPD.
Publications
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.
PubMed 16567260Kim 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.
PubMed 22025941Kim 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.
PubMed 18211323Suk 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.
PubMed 19317705Kim 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.
PubMed 19372327Werner 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.
PubMed 17976787Ahn 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.
PubMed 30735284Read 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.
PubMed 22862758Randall 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.
PubMed 24725821Castro 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/
PubMed 29083581
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Effect of a Sacral Lift on Femoral Vein Size and Exposure in the Emergency Department
- ClinicalTrials.gov ID
- NCT06916741
- Acronym / sponsor ID
- Sacral Lift / Sacral Lift
- Conditions
- Femoral Artery, Cannulation
- Keywords
- femoral artery, ultrasound, femoral vein, sacral lift, cannulation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)University, hospital or other
- Study start
- 23 Jul 2025 (actual)
- Primary completion
- 14 May 2026 (actual)
- Study completion
- Dec 2027 (estimated)
- First posted
- 8 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Sacral Lift First | Experimental | Diagnostic Test: Ultrasound with Sacral liftFemoral vein measurements are first collected using a sacral lift, then collected again without using a sacral lift. |
| Sacral Lift Second | Experimental | Diagnostic Test: Ultrasound with Sacral liftFemoral vein measurements are first collected without using a sacral lift, then collected again using a sacral lift. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult emergency department patients.
Key exclusion criteria (6 listed)
- <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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound with Sacral liftIntervention includes using a sacral lift during ultrasound to collect femoral vein measurements. | Diagnostic test | Sacral Lift First, Sacral Lift Second |
Primary outcome
Potential effect of a sacral lift on femoral vein cross-sectional area
Time frame: From enrollment to end of ultrasound measurements, expected to take up to one hour
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.
3 secondary outcomes
Potential effect of a sacral lift on measurements of femoral vein diameter
Time frame: 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
Time frame: 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
Time frame: From enrollment to end of ultrasound measurements, expected to take up to one hour
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Background: PubMed 16567260Stone 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.
- Background: PubMed 22025941Kim 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.
- Background: PubMed 18211323Kim 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.
- Background: PubMed 19317705Suk 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.
- Background: PubMed 19372327Kim 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.
- Background: PubMed 17976787Werner 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.
- Background: PubMed 30735284Ahn 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.
- Background: PubMed 22862758Read 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.
- Background: PubMed 24725821Randall 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.
- Background: PubMed 29083581Castro 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/
- Individual participant dataSharing planned: No. It is not necessary for the scope of the study to share IPD.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Principal Investigator Dhimitri Nikolla, DO, MS, FACEP, FACOEP principal investigator
Allegheny Health Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound with Sacral lift in people with Femoral Artery and Cannulation, run by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Potential effect of a sacral lift on femoral vein cross-sectional area (time frame: From enrollment to end of ultrasound measurements, expected to take up to one hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06916741, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.