Synergy of Elevation of the Head and Thorax and REBOA During Out-of-Hospital Cardiac Arrest (GRAVITY2)

July 31, 2024 updated by: University Hospital, Grenoble

Synergy of Elevation of the Head and Thorax and Resuscitative Endovascular Balloon Occlusion of the Aorta During Out-of-Hospital Cardiac Arrest: a Pilot Study

Long-term neurological outcome after successful resuscitation of cardiac arrest remains poor, mainly due to cerebral hypoperfusion and severe hypoxic-ischemic brain injuries. Automated head and chest elevation during cardiopulmonary resuscitation (AHUP-CPR) improves cerebral perfusion by decreasing the intracranial pressure and increasing cerebral perfusion in experimental pig studies. The addition of an impedance threshold device (ITD) and active chest compression-decompression device (ACD) improved hemodynamics and cerebral perfusion. In addition, early implementation of AHUP-CPR in patients with out-of-hospital cardiac arrest (OHCA) was associated with improved survival to hospital discharge, in a multicenter observational study. A 2-year prospective clinical trial in Grenoble evaluating this combination was just completed. This study showed for the first time that the value of end-tidal CO2 (EtCO2), a surrogate for cardiopulmonary resuscitation (CPR) quality and cardiac output, measured with this combination therapy, was significantly higher than with standard CPR.

Resuscitative endovascular balloon occlusion of the aorta (REBOA) has recently been proposed during CPR. This technique temporarily diverts blood flow to the coronary and cerebral circulation. Its beneficial effect on hemodynamics, cerebral blood flow and survival has been experimentally validated. In several feasibility studies, encouraging results were observed by slightly optimizing cerebral perfusion and coronary pressure when REBOA was used in combination with standard CPR.

In a porcine model of cardiac arrest, the addition of REBOA to AHUP CPR was associated with a marked improvement in coronary perfusion pressure and near-normalization of cerebral perfusion pressure. These two interventions act synergistically. REBOA directs flow and pressure to the heart and brain, while AHUP CPR improves preload on the right side of the heart and reduces intracranial pressure.

The aims of this clinical investigation are to assess the feasibility of placing a REBOA catheter combined with automated CPR with head and chest elevation, and to quantify the associated changes in clinical parameters for OHCA.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Cardiac arrest remains a leading cause of death, currently affecting more than 275,000 patients in Europe and in the US, annually. As recommended by the American Heart Association (AHA) and the European Resuscitation Council (ERC), the current standard of care for patients with an out-of-hospital cardiac arrest (OHCA) includes manual cardiopulmonary resuscitation (S-CPR). Nearly two-thirds of all patients who suffer from sudden cardiac death are male and their average age is approximately 65 years old. Survival rates from this major health epidemic have remained largely unchanged for decades.

The current standard of care for patients with an out-of-hospital cardiac arrest (OHCA) includes manual cardiopulmonary resuscitation (CPR) delivered at a rate of 100 compressions per minute with a depth of 5 cm (maximum 6 cm). Periodic positive pressure ventilations are recommended to assure adequate oxygenation and periodic inflation of the lungs. This method of CPR has been shown in animals to provide 15-30% of normal blood flow to the heart and brain. Although closed-chest manual S-CPR was initially described more than 50 years ago, survival rates remain low. In Europe and in the US, survival with favorable neurological outcome for all patients following OHCA and treated with S-CPR averages <6% (ranging from <1% to 20%). In addition to the challenges associated with performance of high-quality CPR in a timely manner, closed chest manual CPR is inherently limited due to the lack of mechanical optimization of flow and pressure with conventional CPR. The consequence of this limitation is that blood flow is far less than normal to the brain and other vital organs and brain pressures during the compression phase are too high. Better alternatives that more closely mimic normal physiology are needed.

Automated head and thorax elevation during cardiopulmonary resuscitation (AHUP-CPR) improves cerebral perfusion by decreasing intra-cranial pressure and increasing cerebral perfusion in experimental swine studies. The addition of an impedance threshold device (ITD) and active chest compression-decompression (ACD) improved hemodynamics and cerebral perfusion. Moreover, early implementation of AHUP in out-of-hospital cardiac arrest (OHCA) patients was associated with better survival to hospital discharge, in a multicenter observational study. The investigator had just completed a 2-year prospective clinical trial in Grenoble assessing this combination. This study showed, for the first time, that End-Tidal CO2 value, a surrogate for CPR quality and cardiac output, measured using this combination therapy, was significantly higher compared with standard CPR.

Moreover, it was recently showed the importance of an early implementation of these devices to improve survival. Also, as all these devices have a European Union declaration of conformity (CE mark), this technique of CPR should be proposed as a basic life support, done by the rescuers.

The Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) involves inserting a catheter with a balloon at its tip into a large artery, typically the femoral artery. The catheter is threaded through the blood vessels until it reaches the aorta. Once the catheter is in place, the balloon is inflated to temporarily stop blood flow in the aorta. This halts the blood flow to the lower part of the body and redirects it to the critical organs in the chest and brain. REBOA is widely used in acute trauma care in order to stop massive hemorrhages in the lower part of the body. The use of REBOA was proposed for traumatic cardiac arrest in the latest European Resuscitation Council (ERC) guidelines as an option to stop bleeding. However, REBOA has recently been proposed at the early phase of non-traumatic cardiac arrest in case of failure of initial resuscitation's maneuvers (CPR and first defibrillations attempts). This technique temporarily diverts blood flow towards the coronary and cerebral circulation. It has already shown that, during CPR, when coronary perfusion pressure increase, the chance of ROSC increase too. Moreover, REBOA could increase mean arterial pressure and thus increase cerebral perfusion pressure, defined by the difference between mean arterial pressure and intracranial pressure. The beneficial effects on hemodynamics, cerebral blood flow and survival of REBOA have been already validated experimentally.

In several feasibility studies, encouraging results have been observed by slightly optimizing cerebral and coronary perfusion when REBOA was used in combination with standard CPR.

In a porcine model of cardiac arrest, the addition of REBOA to AHUP-CPR was associated with greatly improved coronary perfusion pressure and almost normalization of cerebral perfusion pressure. Indeed, REBOA increase mean arterial pressure and provide directed flow and pressure to the heart while AHUP-CPR decrease intracranial pressure and improves preload to the right side of the heart, improving cerebral perfusion pressure. In addition with AHUP-CPR, the use of REBOA could highly improve survival rates for cardiac arrest patients.

The aims of the present study project are to evaluate the feasibility of implementing REBOA catheter combined with automated head and thorax elevation CPR and to quantify associated changes in clinical parameters for OHCA patients

Study Type

Interventional

Enrollment (Estimated)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Grenoble, France, 38043
        • University Hospital Grenoble
        • Contact:
        • Contact:
        • Principal Investigator:
          • Guillaume Pr Debaty, MD, PhD
        • Sub-Investigator:
          • Nicolas Dr Segond, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient with age over or equal to 18 years old
  • Patient with a witnessed medical cardiac arrest and with a no-flow duration under 10 min
  • Patient with EtCO2 greater than 20 mmHg at REBOA team arrival
  • Patient located in the Grenoble Metropolitan area
  • Patient affiliated to French social security

Exclusion Criteria:

  • Patient with ROSC before REBOA placement.
  • Patient eligible to extracorporeal life support (according to local guidelines).
  • CA of traumatic origin (including drowning or hanging).
  • Patients whose size is not adapted to the LUCAS device: height of the sternum from 170 to 303 mm or maximum chest width of 449 mm. The use of the LUCAS device is not subject to a patient weight condition.
  • Cardiac arrest for which resuscitation seems unjustified (inevitable death, terminally ill irreversible condition, too long duration of cardiac arrest, advance personal directives of no-resuscitation).
  • Obvious pregnancy at inclusion.
  • Subject in a period of exclusion from another clinical investigation.
  • Patients with a femoral arterial access site that cannot accommodate an 8 Fr (minimum) introduces sheath

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: REBOA
In this quasi-experimental pilot study, a Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) will be introduced by a specifically dedicated team with physicians trained in this practice. In order to allow a chance for return of spontaneous circulation (ROSC) with standard care, REBOA will be placed after 10 minutes of conventional CPR. Conventional CPR will be performed using innovative devices to enhance circulation and cerebral perfusion pressure during CPR, including progressive elevation of the head and thorax, an active chest compression device, and an impedance threshold valve.
Procedure: REBOA

The REBOA device used in this study will be a computer-aided aortic balloon occlusion catheter with safety feedback and automatic inflation and deflation. The device will be used to temporarily inflate a balloon in the descending aorta through a femoral artery introducer sheath which, when inflated, redirects blood flow to the central circulation.

The REBOA will be inserted into the aorta via the femoral artery through an introducer sheath. Once positioned, the balloon will be inflated to occlude the aorta. The REBOA assistant will be attached to the patient's skin with the adhesive on the underside of the assistant.

Device: Head-Up Cardiopulmonary Resuscitation (AHUP-CPR)
Conventional CPR will be performed using an automated head and chest elevation device during cardiopulmonary resuscitation (AHUP-CPR).
Device: Mechanical Chest Compression Device with Active Chest Decompression
In addition to head and thorax elevation, mechanical chest compression will be performed with active chest compression-decompression using a specific mechanical chest compression device.
Other Names:
  • ACD
Device: Impedance Threshold Device
In addition to REBOA, AHUP-CPR and ACD, an impedance threshold device will be used with a dedicated device.
Other Names:
  • ITD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Arterial Pressure (MAP)
Time Frame: Baseline
Difference in mean arterial pressure (MAP) over a 5s period before the initiation of balloon inflation compared 3 minutes after initiation of balloon inflation in a patient treated with AHUP-CPR
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
End-Tidal CO2 (EtCO2)
Time Frame: Baseline
Comparison of End-Tidal CO2 (EtCO2) value before and after REBOA placement.
Baseline
Compression arterial pressure (CP)
Time Frame: Baseline
Comparison of compression arterial pressure (CP) before and after REBOA placement
Baseline
Decompression arterial pressure (DAP)
Time Frame: Baseline
Decompression arterial pressure (DAP) before and after REBOA placement
Baseline
Brain regional O2 saturation (rSO2)
Time Frame: Baseline
Comparison of brain regional O2 saturation (rSO2) value before and after REBOA placement
Baseline
Return to spontaneous circulation (ROSC).
Time Frame: Baseline, 30-day, 3 months
Number and percentage of return to spontaneous circulation (ROSC).
Baseline, 30-day, 3 months
Patients discharged alive.
Time Frame: 30-day
Number and percentage of patients discharged alive.
30-day
Survival
Time Frame: 30-day, 3 months
Number and percentage of 30-day and 3 months survival.
30-day, 3 months
Neurological status
Time Frame: 30-day, 3 months
Neurological status (Cerebral Performance Category (CPC) score and Modified Rankin Scale (MRS) score) at 30-day and 3 months.
30-day, 3 months
REBOA Placement
Time Frame: Baseline
To assess REBOA placement successful rate
Baseline
Blood vessel damage
Time Frame: 30-day
To assess secondary effects of REBOA placement: number of patients with blood vessel damage requiring surgical or endovascular intervention
30-day
Arterial thromboembolism
Time Frame: 30-day
To assess secondary effects of REBOA placement: number of patients with arterial thromboembolism requiring surgical or endovascular intervention,
30-day
Lower extremity amputation
Time Frame: 30-day
To assess secondary effects of REBOA placement: number of patients with lower extremity amputation
30-day
Renal failure
Time Frame: 30-day
To assess secondary effects of REBOA placement: number of patients with renal failure requiring non-temporary dialysis
30-day
Lower extremity paralysis
Time Frame: 30-day
To assess secondary effects of REBOA placement: number of patients with lower extremity paralysis.
30-day
Ventilatory parameter: flow
Time Frame: Out-of-hospital care
To assess flow (L/min) during head-up CPR.
Out-of-hospital care
Ventilatory parameter: tidal volume
Time Frame: Out-of-hospital care
To assess tidal volume adjusted on predicted body weight (mL/PBW) during head-up CPR.
Out-of-hospital care
Ventilatory parameter: airway pressure
Time Frame: Out-of-hospital care
To assess airway pressure (cmH2O) during head-up CPR.
Out-of-hospital care

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Investigators

  • Principal Investigator: Guillaume Pr Debaty, MD, PhD, University Hospital, Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2024

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

July 18, 2024

First Submitted That Met QC Criteria

July 31, 2024

First Posted (Estimated)

August 5, 2024

Study Record Updates

Last Update Posted (Estimated)

August 5, 2024

Last Update Submitted That Met QC Criteria

July 31, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38RC23.0224

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study protocol will be submitted for publication

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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