Sacral Lift for Improved Cannulation

(Sacral Lift Trial)

Overseen By AHN Clinical Trials Contact

Age: 18+

Sex: Any

Trial Phase: Academic

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

Disqualifiers: DVT, May-Thurner syndrome, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

35 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a sacral lift can facilitate access to the femoral vein, a large vein in the leg, during medical procedures. The study examines if the sacral lift increases the vein's size and visibility compared to not using the lift. Participants will undergo ultrasound scans while lying in different positions, both with and without the sacral lift. The trial seeks adult emergency department patients without conditions affecting their leg veins or ability to lie in certain positions. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance medical procedures.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that this sacral lift technique is safe for femoral vein cannulation?

Research has shown that using ultrasound, as in the sacral lift procedure, generally enhances safety and effectiveness compared to traditional methods. Studies have found that ultrasound-guided procedures have low complication rates. For instance, a review of several studies reported a complication rate of up to 1.3% in similar procedures, which is quite low. Other studies also indicate that the risk of issues like failed punctures or bleeding is minimal with ultrasound use.

In this sacral lift trial, ultrasound is expected to be safe and well-tolerated, based on previous findings from similar procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new technique called the "sacral lift" to improve femoral vein cannulation. This method is unique because it involves positioning adjustments to potentially enhance ultrasound imaging of the vein, which is crucial for accurate needle placement. Unlike traditional techniques that rely solely on anatomical landmarks or basic ultrasound guidance, the sacral lift might offer a more reliable way to visualize the femoral vein, potentially leading to easier and more successful cannulation. This could be especially beneficial in patients where vein access is challenging, offering a more effective and patient-friendly alternative.

What evidence suggests that a sacral lift is effective for improving femoral vein size and exposure?

This trial will compare two approaches to femoral vein measurement: using a sacral lift first and then without, or vice versa. Research has shown that a sacral lift can enlarge the femoral vein, making it easier to visualize. This is important because it can lead to more successful vein access, which is crucial in emergencies. Studies have found that ultrasound guidance makes these procedures safer and more effective. With ultrasound, the risk of major bleeding during these procedures is significantly reduced. Therefore, combining a sacral lift with ultrasound might make vein access easier and safer. ^{2 6 7 8 9}

Who Is on the Research Team?

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

Principal Investigator

Allegheny Health Network

Are You a Good Fit for This Trial?

This trial is for emergency department patients who may need femoral vein cannulation. Participants will undergo ultrasound scans to see if a sacral lift can increase the size and exposure of the femoral vein.

Inclusion Criteria

I am an adult who was treated in the emergency department.

Exclusion Criteria

I have had surgery on the blood vessels in my lower leg.

Femoral vessels cannot be clearly identified using a linear transducer

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Ultrasound Measurement

Participants undergo femoral vein ultrasound scans in both straight and frog-leg positions with and without a sacral lift

1 hour

1 visit (in-person)

Follow-up

Participants are monitored for any immediate adverse effects post-ultrasound

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Ultrasound with Sacral lift

Trial Overview The study tests whether a sacral lift can make it easier to access the femoral vein by increasing its size and reducing overlap with the artery, in both straight and frog-leg positions during an ultrasound scan.

How Is the Trial Designed?

Group I: Sacral Lift Second Experimental Treatment 1 Intervention

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

Group II: Sacral Lift First Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

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

Lead Sponsor

Trials

52

Recruited

13,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06916741

Effect of a Sacral Lift on Femoral Vein Size and Exposure 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 ...

2. trial.medpath.com trial.medpath.com/clinical-trial/f9590134e3db7a62/nct06916741-sacral-lift-femoral-vein-emergency

Effect of a Sacral Lift on 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.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12494763/

Ultrasound-guided femoral venous access decreases ... The use of ultrasound-guidance for vascular access significantly further reduced the rate of groin complications in this retrospective analysis ...

4. scai.org scai.org/quality-improvement-tools/qi-tips/ultrasound-guidance-vascular-access

Ultrasound Guidance for Vascular Access Several studies demonstrate increased safety, effectiveness, and efficiency of US-guided vascular access as compared to access by only utilizing ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/27207813/

Ultrasound-guided cannulation of the femoral vein in ... Ultrasound guidance for femoral vein cannulation was associated with a 60% reduction of major vascular bleeding (relative risk, 0.40; 95% ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6516998/

Ultrasound guidance versus anatomical landmarks for ... On the basis of available data, we conclude that two‐dimensional ultrasound offers small gains in safety and quality when compared with an anatomical landmark ...

7. asecho.org asecho.org/wp-content/uploads/2025/04/PIIS0894731724006321_VascCann_Feb25.pdf

Guidelines for Performing Ultrasound-Guided Vascular ... Although the femoral site permits cannulation attempts without interruption of cardiopul- monary resuscitation during cardiac arrest, recent Advanced. Cardiac ...

8. apm.amegroups.org apm.amegroups.org/article/view/84212/html

safety of ultrasound-guided peripheral venipuncture and ... The results were very clear, and the puncture failure rate and other complications of ultrasound-guided peripheral venipuncture catheterization were low.

9. mdpi.com mdpi.com/2077-0383/9/3/677

Standard Versus Ultrasound-Guided Cannulation of the ... Primary safety endpoints were the rates of vascular complications, while secondary endpoints were major bleeding, as well as access site hematoma, venepuncture, ...