Awake Axillary Impella 5.5 Placement - A Feasibility Trial

NCT ID: NCT05782491

Last Updated: 2024-07-19

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-30
• Study Completion Date: 2024-07-18

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.

Conditions

Cardiogenic Shock

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Arm

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

Group Type: EXPERIMENTAL

Interscalene Block

Intervention Type: PROCEDURE

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

Intervention Type: PROCEDURE

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

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Other Intervention Names

Peripheral nerve block; Pectoral Block; Peripheral nerve block; Fascial plane block; Cervical plexus block; Peripheral nerve block

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abiomed Inc.

INDUSTRY

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Asad Usman, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Marisa Cevasco, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

77327727

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

852788

Identifier Type: -

Identifier Source: org_study_id