Ignite Creation Date:
2024-10-25 @ 8:02 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06537492
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-18
Brief Title:
Synergy of Elevation of the Head and Thorax and REBOA During Out-of-Hospital Cardiac Arrest
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GRAVITY2
Brief Summary:
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
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
Detailed Description:
Cardiac arrest remains a leading cause of death currently affecting more than 275000 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 resuscitations 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
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 resuscitations 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None