Clinical trial NCT05782491: Awake Axillary Impella 5.5 Placement - A Feasibility Trial
Official title: Rapid Progression of Care in Cardiogenic Shock - Awake Surgical Placement of the Impella 5.5 Using Regional Anesthesia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cardiogenic Shock
Keywords: Impella 5.5
Cardiogenic shock
PECS II
Interscalene
Superficial Cervical
regional anesthesia
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Abiomed Inc.
First posted: 2023-03-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 10 patients in cardiogenic shock listed for Impella 5.5 placement
Primary purpose: TREATMENT

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.

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
* 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

Primary outcomes:
measure: Success of Using Regional Anesthesia for Impella 5.5 Placement
timeFrame: Day of procedure (1 day)
Secondary outcomes:
measure: Time to participation in physical therapy
timeFrame: 6 weeks
measure: Time to destination therapy
timeFrame: 6 weeks
measure: Sedation requirement
timeFrame: 1 week
measure: Pain medication requirement
timeFrame: 1 week
measure: Patient pain scores post operatively
timeFrame: 3 days
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Penn Presbyterian Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Asad Usman, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Marisa Cevasco, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: