Awake Axillary Impella 5.5 Placement - A Feasibility Trial

University of Pennsylvania

Status: Withdrawn

Conditions: Cardiogenic Shock

Treatments: Procedure: Interscalene Block; Procedure: PECS II Block; Procedure: Superficial Cervical Plexus Block

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05782491

852788

77327727 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

0 participants in 1 patient group

Treatment Arm

Experimental group

Description:

Patient in cardiogenic shock listed for Impella 5.5 placement who meets study inclusion criteria

Treatment:

Procedure: Superficial Cervical Plexus Block

Procedure: PECS II Block

Procedure: Interscalene Block