Rapid Progression of Care in Cardiogenic Shock - Awake Surgical Placement of the Impella 5.5 Using Regional Anesthesia
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Cardiogenic Shock
- Sponsor
- University of Pennsylvania
- Locations
- 2
- Primary Endpoint
- Success of Using Regional Anesthesia for Impella 5.5 Placement
- Status
- Withdrawn
- Last Updated
- last year
Overview
Brief 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.
Detailed Description
General anesthesia places patients who are in cardiogenic shock at risk for life threatening hemodynamic compromise due to the anesthetic and positive pressure ventilation, and confers the need for mechanical ventilation and sedation post operatively. Our hypothesis is that by utilizing regional anesthesia, anesthesiologists can facilitate surgical Impella placement with less risk of cardiovascular collapse with a faster road to recovery. By avoiding endotracheal intubation and concomitant heavy sedation both in the operating room and ICU, these patients will avoid worsening deconditioning and ICU delirium, with less days to physical therapy, ambulation, and recovery as compared to patients who undergo general anesthesia and remain ventilated in the ICU after their Impella placement. Patients scheduled for Impella 5.5 placement will be screened by a specific set of inclusion/exclusion criteria for potential participation in the study. If they consent, they will receive three commonly used upper extremity nerve blocks (Interscalene, PECS II, and superficial cervical plexus nerve blocks) and receive only intravenous sedation during the procedure.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Success of Using Regional Anesthesia for Impella 5.5 Placement
Time Frame: Day of procedure (1 day)
Number of patients that successfully undergo Impella 5.5. placement with the regional anesthesia protocol
Secondary Outcomes
- Patient pain scores post operatively(3 days)
- Time to participation in physical therapy(6 weeks)
- Time to destination therapy(6 weeks)
- Pain medication requirement(1 week)
- Sedation requirement(1 week)