Awake Axillary Impella 5.5 Placement - A Feasibility Trial
Stopped: Research decided not to pursue.
United States0Started 2024-04
Plain-language summary
The Abiomed Impella 5.5 is a surgically placed temporary mechanical support device used in patients in cardiogenic shock. The investigators propose using regional anesthesia (3 separate peripheral nerve blocks) to facilitate Impella 5.5 placement, a procedure which has traditionally been performed under a general anesthetic.
Regional anesthesia is a proven and widely used technique to facilitate upper extremity vascular surgery cases (i.e. arteriovenous fistula creation). The investigators believe that employing these blocks in conjunction with intravenous sedation or monitored anesthesia care (MAC anesthesia) - a technique used in all types of cases, even in sick hearts during thranscatheter aortic valve replacements (TAVR) - will avoid the need increased doses of medications to support the blood pressure and cardiac output, avoid the need for post operative mechanical ventilation and intravenous sedation, and speed up the time to participating in physical therapy, time to heart transplant/durable mechanical support/recovery, and time to hospital discharge.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Baseline Criteria:
* Agrees to procedure
* Excellent ultrasound images for nerve blocks
* Excellent ultrasound images for trans thoracic echo
* Age \<60, BMI \<30
* Non hostile neck
* Evaluation of CT amenable to easy surgical access for Impella placement
Meets criteria for MAC sedation:
* Able to lay relatively flat comfortably
* Able to understand and cooperate with procedures
* Easy airway (Mallampati I - II, prior grade 1-2 airway)
* Low risk of airway obstruction
* No high baseline oxygen requirement (over 6L/min)
Meets criteria for regional anesthesia:
* Patient agrees to nerve block
* No active areas of infection around the block site
* No history of nerve damage or deficits in the area of the proposed nerve block
* No contralateral diaphragmatic paralysis or phrenic nerve palsy
Exclusion Criteria:
* Does not wish to have MAC
* Does not wish to have Regional Anesthesia
* BMI \> 30
* Poor U/S windows for block or TTE
* Active infection over block area
* High Oxygen Requirement \>6L NC
* Known or anticipated difficult airway
* Unable to lay flat comfortably Unable to cooperate or follow instructions
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Success of Using Regional Anesthesia for Impella 5.5 Placement