CompuFlo thoracic epidural placement for Aortic Dissection

Phase-Based Estimates
1
Effectiveness
1
Safety
University of Iowa Hospitals and Clinics, Iowa City, IA
Aortic Dissection+1 More
CompuFlo thoracic epidural placement - Device
Eligibility
18+
All Sexes
Eligible conditions
Aortic Dissection

Study Summary

This study is evaluating whether a new device can improve the success rate of epidural placement.

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Eligible Conditions

  • Aortic Dissection
  • Aneurysm, Dissecting
  • Thoracic Epidural Anesthesia

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether CompuFlo thoracic epidural placement will improve 1 primary outcome and 10 secondary outcomes in patients with Aortic Dissection. Measurement will happen over the course of Immediate-during the procedure.

Hour 48
Measure post-operative -Opioid Usage
Hour 48
Measure post-operative pain scores
Immediate-during the procedure
Analyze pressure levels recorded in CompuFlo group
Analyze recorded waveforms in the CompuFlo group
Calculate the amount of time required for the procedure
Calculate unintentional dural puncture
Ease of catheter placement/threading
Meniscus test - Changes observed in the epidural catheter with changes in position
Maximum 20 minutes post administration of epidural test dose
Calculate success rate of thoracic epidural catheter placement-Traditional versus CompuFlo
Up to 20 minutes post administration of epidural test dose
Measure change in blood pressure
Time taken for loss of cold sensation

Trial Safety

Trial Design

2 Treatment Groups

Traditional epidural group
CompuFlo epidural group

This trial requires 133 total participants across 2 different treatment groups

This trial involves 2 different treatments. CompuFlo Thoracic Epidural Placement is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

CompuFlo epidural group
Device
This device (CompuFlo) will aid in correct placement of the epidural by electronically sensing pressure in real time and by providing a numerical value on a read out screen to determine a loss of resistance. There is also an audio signal that signals a loss of resistance.
Traditional epidural group
Device
The traditional approach to placing thoracic epidurals by loss-of-resistance technique using a ground glass syringe will be used in this group.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: immediate-during the procedure
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly immediate-during the procedure for reporting.

Closest Location

University of Iowa Hospitals and Clinics - Iowa City, IA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Age: 18 to 70
English is the subject's first language
The text is saying that in order to participate in the study, you must be able to sign an informed consent form. show original
This text states that a healthy BMI range is from 18 to 50 kg/m2. show original
Make sure the patient is comfortable before, during, and after surgery show original
Patients with rib fractures should be given pain control. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is aortic dissection?

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Aortic dissection progresses in two phases with a sudden onset (generally within a month), but a gradual development of dissection, which can occur years later. Untreated aortic dissection can lead to fatal bleeding, which necessitates immediate surgery with the aortic reconstruction. It is very rare for the acute phase of the dissection to heal spontaneously. It is often diagnosed by CT scan imaging, and is treated by surgical repair or endovascular repair.

Unverified Answer

How many people get aortic dissection a year in the United States?

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5.5 per 100,000 people have been reported to have aortic dissection annually. The peak incidence is in the 5th and 7th decades. The most frequent complications are aortic aneurysms. The sex ratio is less than 1:0.4 for patients under the age of 45 years, and for patients more than 70 years old the ratio is about 1:9.5. Patients more than 80 years of age were found to have an increased risk of complications (complications: aortic dissection 2.7, aortic aneurysms 6.5, pulmonary dissection 1.4). Patients with renal disease were in the group with complications 6.

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What are the signs of aortic dissection?

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Individuals with aortic lesions have a higher incidence of cardiovascular risk factors, but it may be clinically difficult to differentiate between dissection (aortitis) and aneurysm. Signs such as tenderness over the left iliac and above the left shoulder, pleuritic chest pain, and lower back pain are suggestive of dissection although aortic aneurysms do not produce these findings. There are significant advantages to imaging with magnetic resonance angiography and the computed tomography angiogram is preferable to chest x-ray for this purpose.

Unverified Answer

What causes aortic dissection?

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The data suggests a possible aetiology for aortic dissection. More rigorous analyses are needed to further elucidate whether the increased prevalence of dissection among men who have smoked and those with high levels of circulating hormones and cytokines may represent an independent risk, or may be an artefact of the increased prevalence of CAD in men with aortic dissection.

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Can aortic dissection be cured?

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AD can be treated. However, for patients who do not benefit from surgical intervention, there is no guarantee that their symptoms will not recur during the follow-up.

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What are common treatments for aortic dissection?

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Aortic dissection occurs in 1 out of every 5,500 patients every year in the United States. Over half of patients are male, more than 80% are in their sixth decade of life, and 90% present with symptoms of thoracic aortic dissection. Surgical intervention is the primary treatment for aortic dissection, accounting for approximately 40% of treatment options. Surgical treatment is most often performed within 4 days of dissection onset. Endovascular and endovascular with an aortic reconstruction strategy are important new approaches which are currently being explored to improve outcomes.

Unverified Answer

Is compuflo thoracic epidural placement typically used in combination with any other treatments?

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Epidural placement alone might be appropriate for certain patients with AAD. The combination of epidural placement with medical management may be effective in some patients, although the potential for a greater complication rate needs to be weighed against the potential benefits.

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What are the common side effects of compuflo thoracic epidural placement?

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For this patient population, the incidence of brachial plexus and epidural-related adverse events was very low, with a few instances of transient paresthesias and occasional mild systemic reactions. These side effects are transient and seldom interfere with epidural continuation.

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What is the latest research for aortic dissection?

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Treatment for acute uncomplicated AAD is associated with better outcomes compared to untreated AAD and is equivalent to treatment of AAD complicated by cardiogenic shock. Treatment with surgical repair is associated with improved long-term survival compared to percutaneous repair of AAD, and seems safe in the subgroup of AAD complicated by cardiogenic shock.

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Does aortic dissection run in families?

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These data are only a guide for referral of patients with aortic dissection for clinical trials; family members should be questioned regarding any history of aortic dissection or disease, and any aortic dissection in a close relative.

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What is compuflo thoracic epidural placement?

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In a recent study, findings, 1 of every 10 patients developed pneumothorax. The majority developed pneumothorax after a thoracic epidural placement to treat radicular pain and upper extremity pain from thoracic procedures. The study concludes that patients should be monitored closely for pneumothorax after thoracic epidural placement in this population.

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What are the latest developments in compuflo thoracic epidural placement for therapeutic use?

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The Compuflo thoracic epidural catheter allows for a continuous and localized infusion of low density and volume solutions, thereby providing comfort to patients and a low risk of neurologic damage. The placement requires a single epidural space, eliminates the need for anesthesia with related complications, and decreases the risk of epidural hematoma. The technique eliminates or reduces the use of needles, resulting in reduced radiation exposure and time required for the procedure. These variables would help a clinician make a quick clinical decision at the bedside.

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