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

Trial Summary

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 data supports the effectiveness of the treatment Ultrasound with Sacral lift for improved cannulation?

Research shows that using ultrasound for guiding vein and artery access can make the process safer and more successful by allowing doctors to see the vessels and surrounding areas clearly. This reduces the chances of complications and unsuccessful attempts, which suggests that ultrasound could be effective in improving cannulation. ^{1 2 3 4 5}

Is the sacral lift technique safe for use in humans?

Research on using ultrasound guidance for sacral procedures, like caudal blocks, shows that it can be done safely without accidental injections into blood vessels, suggesting it is generally safe for humans. ^{6 7 8 9 10}

How does the Sacral Lift treatment differ from other treatments for improved cannulation?

The Sacral Lift treatment is unique because it likely involves a physical maneuver or positioning technique to improve the success of cannulation, which is different from the common use of ultrasound guidance to visualize veins for cannulation. This approach may offer an alternative for patients where ultrasound is not feasible or available. ^{1 2 11 12 13}

What is the purpose of this trial?

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.

Research Team

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

Principal Investigator

Allegheny Health Network

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. England pubmed.ncbi.nlm.nih.gov

Ultrasonic locating devices for central venous cannulation: meta-analysis. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Location of the Central Venous Catheter Tip With Bedside Ultrasound in Young Children: Can We Eliminate the Need for Chest Radiography? [2016]

3. United States pubmed.ncbi.nlm.nih.gov

Credentialing of Hospitalists in Ultrasound-Guided Bedside Procedures: A Position Statement of the Society of Hospital Medicine. [2019]

4. Germany pubmed.ncbi.nlm.nih.gov

[Ultrasound techniques in anesthesiology--guided vascular access using sonography]. [2015]

5. United States pubmed.ncbi.nlm.nih.gov

Ultrasound Guided Out-of-Plane Versus In-Plane Transpectoral Left Axillary Vein Cannulation. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Ultrasound-guided versus conventional injection for caudal block in children: A prospective randomized clinical study. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Ultrasound guidance in caudal epidural needle placement. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Anatomical Evaluation of the Sacral Hiatus Using Ultrasound Imaging: Factors That Inhibit Needle Insertion During Caudal Epidural Block Procedures. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Ultrasound as a screening tool for proceeding with caudal epidural injections. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

The Influence of Ultrasound-Guided Technique Using a Catheter-Over-Needle on the Incidence of Accidental Intravascular Injection during Caudal Block-A Retrospective Case Series Study. [2021]

11. Hungary pubmed.ncbi.nlm.nih.gov

[Peripheral venous access with ultrasound guidance]. [2013]

12. United States pubmed.ncbi.nlm.nih.gov

Ultrasound-guided peripheral intravenous catheters insertion in patient with difficult vascular access: Short axis/out-of-plane versus long axis/in-plane, a randomized controlled trial. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Ultrasound-guided vascular access in critical illness. [2020]