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Awake Axillary Impella 5.5 Placement - A Feasibility Trial

Primary Purpose

Cardiogenic Shock

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Interscalene Block
PECS II Block
Superficial Cervical Plexus Block
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiogenic Shock focused on measuring Impella 5.5, Cardiogenic shock, PECS II, Interscalene, Superficial Cervical, regional anesthesia

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Hospital of the University of Pennsylvania
  • Penn Presbyterian Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Arm

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Time to participation in physical therapy
Time from end of operation to getting out of bed or involving in physical therapy sessions
Time to destination therapy
Time to decision of heart transplant, ventricular assist device, or recovery
Sedation requirement
Total dose of sedatives required post operatively
Pain medication requirement
Total dose of pain medication required post operatively
Patient pain scores post operatively
The Numeric Pain Rating Scale score on post operative evaluations

Full Information

First Posted
February 24, 2023
Last Updated
September 27, 2023
Sponsor
University of Pennsylvania
Collaborators
Abiomed Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05782491
Brief Title
Awake Axillary Impella 5.5 Placement - A Feasibility Trial
Official Title
Rapid Progression of Care in Cardiogenic Shock - Awake Surgical Placement of the Impella 5.5 Using Regional Anesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
Abiomed Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiogenic Shock
Keywords
Impella 5.5, Cardiogenic shock, PECS II, Interscalene, Superficial Cervical, regional anesthesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
10 patients in cardiogenic shock listed for Impella 5.5 placement
Masking
None (Open Label)
Masking Description
No blinding in this study
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Arm
Arm Type
Experimental
Arm Description
Patient in cardiogenic shock listed for Impella 5.5 placement who meets study inclusion criteria
Intervention Type
Procedure
Intervention Name(s)
Interscalene Block
Other Intervention Name(s)
Peripheral nerve block
Intervention Description
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
Intervention Name(s)
PECS II Block
Other Intervention Name(s)
Pectoral Block, Peripheral nerve block, Fascial plane block
Intervention Description
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
Intervention Name(s)
Superficial Cervical Plexus Block
Other Intervention Name(s)
Cervical plexus block, Peripheral nerve block
Intervention Description
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.
Primary Outcome Measure Information:
Title
Success of Using Regional Anesthesia for Impella 5.5 Placement
Description
Number of patients that successfully undergo Impella 5.5. placement with the regional anesthesia protocol
Time Frame
Day of procedure (1 day)
Secondary Outcome Measure Information:
Title
Time to participation in physical therapy
Description
Time from end of operation to getting out of bed or involving in physical therapy sessions
Time Frame
6 weeks
Title
Time to destination therapy
Description
Time to decision of heart transplant, ventricular assist device, or recovery
Time Frame
6 weeks
Title
Sedation requirement
Description
Total dose of sedatives required post operatively
Time Frame
1 week
Title
Pain medication requirement
Description
Total dose of pain medication required post operatively
Time Frame
1 week
Title
Patient pain scores post operatively
Description
The Numeric Pain Rating Scale score on post operative evaluations
Time Frame
3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Samuel Cohen, MD, MS
Phone
‪(215) 720-1357‬
Email
samuel.cohen@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Asad Usman, MD, MPH
Phone
‭+1 (267) 602-7025‬
Email
asad.usman@pennmedicine.upenn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asad Usman, MD, MPH
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marisa Cevasco, MD, MPH
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Asad Usman, MD, MPH
Phone
267-602-7025
Email
asad.usman@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name & Degree
Asad Usman, MD, MPH
First Name & Middle Initial & Last Name & Degree
Cohen Samuel, MD, MS
Facility Name
Penn Presbyterian Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Asad Usman, MD, MPH
Phone
267-602-7025
Email
asad.usman@pennmedicine.upenn.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Awake Axillary Impella 5.5 Placement - A Feasibility Trial

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