Cardiogenic ShockNCT05782491
Awake Axillary Impella 5.5 Placement - A Feasibility Trial
A study testing Interscalene Block, PECS II Block and Superficial Cervical Plexus Block in people with Cardiogenic Shock, run by University of Pennsylvania at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cardiogenic Shock
- What is being tested?
- Interscalene Block, PECS II Block and Superficial Cervical Plexus Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2024to 18 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 18Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
About this study
Official title: Rapid Progression of Care in Cardiogenic Shock - Awake Surgical Placement of the Impella 5.5 Using Regional Anesthesia
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.
Read the 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
- Being tested
- Interscalene Block, PECS II Block, Superficial Cervical Plexus Block
- Keywords
- Impella 5.5, Cardiogenic shock, PECS II, Interscalene, Superficial Cervical, regional anesthesia
- Medical subject headings
- Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interscalene BlockProcedure or surgery
Also called Peripheral nerve 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 BlockProcedure or surgery
Also called Pectoral Block, Peripheral nerve block, Fascial plane 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 BlockProcedure or surgery
Also called Cervical plexus block, Peripheral nerve 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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Patient in cardiogenic shock listed for Impella 5.5 placement who meets study inclusion criteria Receives: Procedure: Interscalene Block; Procedure: PECS II Block; Procedure: Superficial Cervical Plexus Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day of procedure (1 day)
Secondary outcomes (5)
Time to participation in physical therapy
Time from end of operation to getting out of bed or involving in physical therapy sessions
Measured: 6 weeks
Time to destination therapy
Time to decision of heart transplant, ventricular assist device, or recovery
Measured: 6 weeks
Sedation requirement
Total dose of sedatives required post operatively
Measured: 1 week
Pain medication requirement
Total dose of pain medication required post operatively
Measured: 1 week
Patient pain scores post operatively
The Numeric Pain Rating Scale score on post operative evaluations
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study startApr 2024 (estimated)
- Primary completionApr 2024 (estimated)
- Study completion18 Jul 2024
Why it stopped: Research decided not to pursue.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiogenic ShockStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 10 patients in cardiogenic shock listed for Impella 5.5 placement
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Abiomed Inc.
- Responsible party
- Sponsor
- Investigators
- Asad Usman, MD, MPH, Principal investigator, University of PennsylvaniaMarisa Cevasco, MD, MPH, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05782491
- Sponsor's protocol ID
- 852788
- Other IDs
- 77327727
- Status last verified
- Jul 2024
- First submitted
- 24 Feb 2023
- Last updated
- 19 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Progression of Care in Cardiogenic Shock - Awake Surgical Placement of the Impella 5.5 Using Regional Anesthesia
- ClinicalTrials.gov ID
- NCT05782491
- Acronym / sponsor ID
- 852788
- Conditions
- Cardiogenic Shock
- Keywords
- Impella 5.5, Cardiogenic shock, PECS II, Interscalene, Superficial Cervical, regional anesthesia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Research decided not to pursue.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Abiomed Inc.
- Study start
- Apr 2024 (estimated)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- 18 Jul 2024 (actual)
- First posted
- 23 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 10 patients in cardiogenic shock listed for Impella 5.5 placement
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Procedure: Interscalene Block, Procedure: PECS II Block, Procedure: Superficial Cervical Plexus BlockPatient in cardiogenic shock listed for Impella 5.5 placement who meets study inclusion criteria |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (18 listed)
- Agrees to procedure
- Excellent ultrasound images for nerve blocks
- Excellent ultrasound images for trans thoracic echo
- Age <60, BMI <30
- Non hostile neck
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interscalene BlockAlso: Peripheral nerve blockIt 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. | Procedure or surgery | Treatment Arm |
| PECS II BlockAlso: Pectoral Block, Peripheral nerve block, Fascial plane blockPECS 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. | Procedure or surgery | Treatment Arm |
| Superficial Cervical Plexus BlockAlso: Cervical plexus block, Peripheral nerve blockThis 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. | Procedure or surgery | Treatment Arm |
Primary outcome
Success of Using Regional Anesthesia for Impella 5.5 Placement
Time frame: Day of procedure (1 day)
Number of patients that successfully undergo Impella 5.5. placement with the regional anesthesia protocol
5 secondary outcomes
Time to participation in physical therapy
Time frame: 6 weeks
Time to destination therapy
Time frame: 6 weeks
Sedation requirement
Time frame: 1 week
Pain medication requirement
Time frame: 1 week
Patient pain scores post operatively
Time frame: 3 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asad Usman, MD, MPH principal investigator
University of Pennsylvania
Marisa Cevasco, MD, MPH principal investigator
University of Pennsylvania
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interscalene Block, PECS II Block and Superficial Cervical Plexus Block in people with Cardiogenic Shock, run by University of Pennsylvania at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success of Using Regional Anesthesia for Impella 5.5 Placement (time frame: Day of procedure (1 day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2024.