Awake Axillary Impella 5.5 Placement - A Feasibility Trial

Cardiogenic Shock Clinical Trial

Official title:

Rapid Progression of Care in Cardiogenic Shock - Awake Surgical Placement of the Impella 5.5 Using Regional Anesthesia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05782491
• Other study ID #: 852788
• Secondary ID: 77327727
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: August 2024

Study information

• Verified date: February 2024
• Source: University of Pennsylvania
• Contact: Samuel Cohen, MD, MS
• Phone: ?(215) 720-1357?
• Email: samuel.cohen[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: August 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiogenic Shock
• Shock
• Shock, Cardiogenic

Intervention

Procedure:
• Interscalene 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.
• PECS 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.
• Superficial 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.

Locations

Country	Name	City	State
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Penn Presbyterian Medical Center	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	Abiomed Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success of Using Regional Anesthesia for Impella 5.5 Placement	Number of patients that successfully undergo Impella 5.5. placement with the regional anesthesia protocol	Day of procedure (1 day)
Secondary	Time to participation in physical therapy	Time from end of operation to getting out of bed or involving in physical therapy sessions	6 weeks
Secondary	Time to destination therapy	Time to decision of heart transplant, ventricular assist device, or recovery	6 weeks
Secondary	Sedation requirement	Total dose of sedatives required post operatively	1 week
Secondary	Pain medication requirement	Total dose of pain medication required post operatively	1 week
Secondary	Patient pain scores post operatively	The Numeric Pain Rating Scale score on post operative evaluations	3 days