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Regional Anesthesia for Cardiogenic Shock
N/A
Waitlist Available
Led By Asad Usman, MD, MPH
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No history of nerve damage or deficits in the area of the proposed nerve block
No contralateral diaphragmatic paralysis or phrenic nerve palsy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights
Study Summary
This trial will explore using regional anesthesia to help place a temporary mechanical support device in patients with cardiogenic shock, avoiding need for general anesthetic & supporting a quicker recovery.
Who is the study for?
This trial is for individuals under 60 years old with a BMI less than 30, who are in cardiogenic shock but can lay flat comfortably and cooperate during the procedure. They must have no history of nerve damage, infections at the block site, or high oxygen needs over 6L/min. The neck anatomy should be suitable for surgery without complications.Check my eligibility
What is being tested?
The trial tests if regional anesthesia (3 types of nerve blocks) can replace general anesthesia when placing an Impella 5.5 heart pump in patients with severe heart issues. This could potentially reduce medication doses, avoid post-op ventilation, and speed up recovery and hospital discharge.See study design
What are the potential side effects?
Possible side effects include discomfort or bruising at the injection sites, allergic reactions to local anesthetics used in the nerve blocks, temporary weakness or numbness around blocked nerves, and rare risks like infection or nerve damage.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have no history of nerve damage where the nerve block will be done.
Select...
I do not have paralysis on the opposite side of my diaphragm.
Select...
I do not have any infections near the treatment area.
Select...
I am under 60 years old and my BMI is below 30.
Select...
I do not need more than 6 liters of oxygen per minute.
Select...
I agree to have a nerve block.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Success of Using Regional Anesthesia for Impella 5.5 Placement
Secondary outcome measures
Pain medication requirement
Patient pain scores post operatively
Sedation requirement
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment ArmExperimental Treatment3 Interventions
Patient in cardiogenic shock listed for Impella 5.5 placement who meets study inclusion criteria
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Superficial Cervical Plexus Block
2014
N/A
~40
Interscalene Block
2016
Completed Phase 3
~150
Find a Location
Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,000 Previous Clinical Trials
42,880,078 Total Patients Enrolled
Abiomed Inc.Industry Sponsor
41 Previous Clinical Trials
34,545 Total Patients Enrolled
Asad Usman, MD, MPHPrincipal InvestigatorUniversity of Pennsylvania
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a clear airway and no difficulty breathing.I have no history of nerve damage where the nerve block will be done.I do not have paralysis on the opposite side of my diaphragm.I need more than 6 liters of oxygen per minute.I can lay down flat comfortably.I do not have any infections near the treatment area.The ultrasound images for the heart are very clear and detailed.I cannot lay flat comfortably or follow instructions well.My heart can be easily reached for a pump placement surgery.You have an ongoing infection in the area being studied.I do not want to receive MAC during my procedure.You have a body mass index (BMI) higher than 30.The neck does not show signs of hostility or aggression.I am under 60 years old and my BMI is below 30.I do not need more than 6 liters of oxygen per minute.I do not want regional anesthesia.It is difficult to see the heart or blood vessels clearly using ultrasound.You have a known or expected problem with breathing during the study.I understand and can follow the study's procedures.High-quality ultrasound images are needed for nerve blocks.My risk of airway blockage is low.I agree to have a nerve block.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any qualifications or criteria required to join this trial?
"The requirements to enroll in this medical trial include cardiogenic shock and an age between 18-60. At the moment, around 10 participants are being sought out."
Answered by AI
Is this research restricted to individuals over a certain age limit?
"Qualifying participants must be 18 or older, yet not exceed the age of 60."
Answered by AI
Are there available slots for participants in this research project?
"The clinicaltrials.gov repository indicates that, unfortunately, this medical trial is no longer recruiting patients - the study was initially posted on August 1st 2023 and last updated 3/22/2023. Nevertheless, 145 alternative research trials are currently welcoming participants to join their investigations."
Answered by AI
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