Awake Axillary Impella 5.5 Placement - A Feasibility Trial

Sponsor

University of Pennsylvania (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05782491

Collaborator

Abiomed Inc. (Industry)

Enrollment

Locations

Arm

Anticipated Duration (Months)

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiogenic Shock	Procedure: Interscalene Block Procedure: PECS II Block Procedure: Superficial Cervical Plexus Block	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

10 patients in cardiogenic shock listed for Impella 5.5 placement10 patients in cardiogenic shock listed for Impella 5.5 placement

Masking:

None (Open Label)

Masking Description:

No blinding in this study

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Apr 1, 2024

Anticipated Study Completion Date :

Aug 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Arm Patient in cardiogenic shock listed for Impella 5.5 placement who meets study inclusion criteria	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. Other Names: Peripheral nerve block Procedure: 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. Other Names: Pectoral Block Peripheral nerve block Fascial plane block Procedure: 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. Other Names: Cervical plexus block Peripheral nerve block

Arm

Intervention/Treatment

Experimental: Treatment Arm

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

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.

Other Names:

Peripheral nerve block

Procedure: 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.

Other Names:

Pectoral Block

Peripheral nerve block

Fascial plane block

Procedure: 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.

Other Names:

Cervical plexus block

Peripheral nerve block

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
2	Penn Presbyterian Medical Center	Philadelphia	Pennsylvania	United States	19104