Awake Axillary Impella 5.5 Placement - A Feasibility Trial

NCT05782491 | Withdrawn

• 2 other identifiers: 85278877327727
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Cardiogenic Shock

Keywords

Impella 5.5; Cardiogenic shock; PECS II; Interscalene; Superficial Cervical; regional anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Time to participation in physical therapy

  6 weeks

• Time to destination therapy

  6 weeks

• Sedation requirement

  1 week

• Pain medication requirement

  1 week

• Patient pain scores post operatively

  3 days

Study Arms (1)

Treatment Arm

EXPERIMENTAL

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

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

Interventions

Interscalene Block 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.

Also known as: Peripheral nerve block

Treatment Arm

PECS II Block 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.

Also known as: Pectoral Block, Peripheral nerve block, Fascial plane block

Treatment Arm

Superficial Cervical Plexus Block 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.

Also known as: Cervical plexus block, Peripheral nerve block

Treatment Arm

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• Abiomed Inc.: collaborator

Study Sites (2)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Shock, Cardiogenic

Interventions

Cervical Plexus Block

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Intervention Hierarchy (Ancestors)

Nerve Block; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Asad Usman, MD, MPH

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Marisa Cevasco, MD, MPH

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No blinding in this study
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 10 patients in cardiogenic shock listed for Impella 5.5 placement

Study Record Dates

• First Submitted: February 24, 2023
• First Posted: March 23, 2023
• Study Start: April 1, 2024
• Primary Completion: April 1, 2024
• Study Completion: July 18, 2024
• Last Updated: July 19, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)