Cardiogenic Shock
Conditions
Keywords
Impella 5.5, Cardiogenic shock, PECS II, Interscalene, Superficial Cervical, regional anesthesia
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.
Interventions
PROCEDUREInterscalene Block
It is an ultrasound guided brachial plexus nerve block at roots/trunks used to anesthetize the shoulder and upper arm. Goal is to spread local anesthetic around superior and middle trunks of brachial plexus, between the anterior and middle scalene muscles.
PROCEDUREPECS II Block
PECS II block is comprised of two separate fascial plane blocks to anesthetize anterolateral chest wall using an ultrasound guided injection between the pectoralis major muscle and pectoralis minor muscle at third rib and a second ultrasound guided injection between pectoralis minor and serratus anterior. The goal is a high volume hydro dissection of the two fascial planes to anesthetize anterolateral chest wall and axilla.
PROCEDURESuperficial Cervical Plexus Block
This block is a superficial injection to the deep cervical fascia between the investing layer of the deep cervical fascia and the prevertebral fascia in the neck. This block provides anesthesia of the skin of the anterolateral neck and the ante-auricular and retro-auricular areas, as well as the skin overlying and immediately inferior to the clavicle on the chest wall. This is an ultrasound guided injection with the goal of placing the needle tip in the fascial layer underneath the SCM adjacent to the cervical plexus, which is contained within the tissue space between the Cervical fascia and posterior sheath of the SCM.
Sponsors
Abiomed Inc.
University of Pennsylvania
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
No blinding in this study
Intervention model description
10 patients in cardiogenic shock listed for Impella 5.5 placement
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success of Using Regional Anesthesia for Impella 5.5 Placement | Day of procedure (1 day) | Number of patients that successfully undergo Impella 5.5. placement with the regional anesthesia protocol |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to participation in physical therapy | 6 weeks | Time from end of operation to getting out of bed or involving in physical therapy sessions |
| Time to destination therapy | 6 weeks | Time to decision of heart transplant, ventricular assist device, or recovery |
| Sedation requirement | 1 week | Total dose of sedatives required post operatively |
| Pain medication requirement | 1 week | Total dose of pain medication required post operatively |
| Patient pain scores post operatively | 3 days | The Numeric Pain Rating Scale score on post operative evaluations |
Countries
United States
Outcome results
None listed