Heart ArrestGRAVITY2NCT06537492
Synergy of Elevation of the Head and Thorax and REBOA During Out-of-Hospital Cardiac Arrest
A study testing REBOA, Head-Up Cardiopulmonary Resuscitation (AHUP-CPR) and Mechanical Chest Compression Device with Active Chest Decompression in people with Heart Arrest and Cardiac Arrest, Out-Of-Hospital, run by University Hospital, Grenoble at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Arrest, Cardiac Arrest, Out-Of-Hospital, Cardiopulmonary Arrest
- What is being tested?
- REBOA, Head-Up Cardiopulmonary Resuscitation (AHUP-CPR) and Mechanical Chest Compression Device with Active Chest Decompression
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2024to Jan 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
University Hospital Grenoble
Grenoble, 38043
Guillaume Pr Debaty, MD, PhD, 0476634256 ext. +33, gdebaty@chu-grenoble.fr
Johanna Boeuf, MSc, 0476634256 ext. +33, jboeuf1@chu-grenoble.fr
About this study
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
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.
Read more
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.
Read the 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
- Conditions
- Heart Arrest, Cardiac Arrest, Out-Of-Hospital, Cardiopulmonary Arrest, Cardiopulmonary Resuscitation
- Being tested
- REBOA, Head-Up Cardiopulmonary Resuscitation (AHUP-CPR), Mechanical Chest Compression Device with Active Chest Decompression, Impedance Threshold Device
- Keywords
- Resuscitative endovascular balloon, Head-up cardiopulmonary resuscitation
- Medical subject headings
- Heart Arrest, Out-of-Hospital Cardiac Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REBOAProcedure or surgery
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.
Head-Up Cardiopulmonary Resuscitation (AHUP-CPR)Device
Conventional CPR will be performed using an automated head and chest elevation device during cardiopulmonary resuscitation (AHUP-CPR).
Mechanical Chest Compression Device with Active Chest DecompressionDevice
Also called ACD
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.
Impedance Threshold DeviceDevice
Also called ITD
In addition to REBOA, AHUP-CPR and ACD, an impedance threshold device will be used with a dedicated device.
| Study group | Role | What they receive |
|---|---|---|
| REBOA | Experimental | 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. Receives: Procedure: REBOA; Device: Head-Up Cardiopulmonary Resuscitation (AHUP-CPR); Device: Mechanical Chest Compression Device with Active Chest Decompression; Device: Impedance Threshold Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Arterial Pressure (MAP)
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
Measured: Baseline
Secondary outcomes (17)
End-Tidal CO2 (EtCO2)
Comparison of End-Tidal CO2 (EtCO2) value before and after REBOA placement.
Measured: Baseline
Compression arterial pressure (CP)
Comparison of compression arterial pressure (CP) before and after REBOA placement
Measured: Baseline
Decompression arterial pressure (DAP)
Decompression arterial pressure (DAP) before and after REBOA placement
Measured: Baseline
Brain regional O2 saturation (rSO2)
Comparison of brain regional O2 saturation (rSO2) value before and after REBOA placement
Measured: Baseline
Return to spontaneous circulation (ROSC).
Number and percentage of return to spontaneous circulation (ROSC).
Measured: Baseline, 30-day, 3 months
Patients discharged alive.
Number and percentage of patients discharged alive.
Measured: 30-day
Survival
Number and percentage of 30-day and 3 months survival.
Measured: 30-day, 3 months
Neurological status
Neurological status (Cerebral Performance Category (CPC) score and Modified Rankin Scale (MRS) score) at 30-day and 3 months.
Measured: 30-day, 3 months
REBOA Placement
To assess REBOA placement successful rate
Measured: Baseline
Blood vessel damage
To assess secondary effects of REBOA placement: number of patients with blood vessel damage requiring surgical or endovascular intervention
Measured: 30-day
Arterial thromboembolism
To assess secondary effects of REBOA placement: number of patients with arterial thromboembolism requiring surgical or endovascular intervention,
Measured: 30-day
Lower extremity amputation
To assess secondary effects of REBOA placement: number of patients with lower extremity amputation
Measured: 30-day
Renal failure
To assess secondary effects of REBOA placement: number of patients with renal failure requiring non-temporary dialysis
Measured: 30-day
Lower extremity paralysis
To assess secondary effects of REBOA placement: number of patients with lower extremity paralysis.
Measured: 30-day
Ventilatory parameter: flow
To assess flow (L/min) during head-up CPR.
Measured: Out-of-hospital care
Ventilatory parameter: tidal volume
To assess tidal volume adjusted on predicted body weight (mL/PBW) during head-up CPR.
Measured: Out-of-hospital care
Ventilatory parameter: airway pressure
To assess airway pressure (cmH2O) during head-up CPR.
Measured: Out-of-hospital care
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study startOct 2024 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Heart ArrestStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume Pr Debaty, MD, PhD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06537492
- Sponsor's protocol ID
- 38RC23.0224
- Acronym
- GRAVITY2
- Status last verified
- Jul 2024
- First submitted
- 18 Jul 2024
- Last updated
- 5 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol will be submitted for publication
Publications
Perkins GD, Callaway CW, Haywood K, Neumar RW, Lilja G, Rowland MJ, Sawyer KN, Skrifvars MB, Nolan JP. Brain injury after cardiac arrest. Lancet. 2021 Oct 2;398(10307):1269-1278. doi: 10.1016/S0140-6736(21)00953-3. Epub 2021 Aug 26.
PubMed 34454687Duhem H, Moore JC, Rojas-Salvador C, Salverda B, Lick M, Pepe P, Labarere J, Debaty G, Lurie KG. Improving post-cardiac arrest cerebral perfusion pressure by elevating the head and thorax. Resuscitation. 2021 Feb;159:45-53. doi: 10.1016/j.resuscitation.2020.12.016. Epub 2020 Dec 29.
PubMed 33385469Ryu HH, Moore JC, Yannopoulos D, Lick M, McKnite S, Shin SD, Kim TY, Metzger A, Rees J, Tsangaris A, Debaty G, Lurie KG. The Effect of Head Up Cardiopulmonary Resuscitation on Cerebral and Systemic Hemodynamics. Resuscitation. 2016 May;102:29-34. doi: 10.1016/j.resuscitation.2016.01.033. Epub 2016 Feb 22.
PubMed 26905388Moore JC, Salverda B, Rojas-Salvador C, Lick M, Debaty G, G Lurie K. Controlled sequential elevation of the head and thorax combined with active compression decompression cardiopulmonary resuscitation and an impedance threshold device improves neurological survival in a porcine model of cardiac arrest. Resuscitation. 2021 Jan;158:220-227. doi: 10.1016/j.resuscitation.2020.09.030. Epub 2020 Oct 4.
PubMed 33027619Moore JC, Salverda B, Lick M, Rojas-Salvador C, Segal N, Debaty G, Lurie KG. Controlled progressive elevation rather than an optimal angle maximizes cerebral perfusion pressure during head up CPR in a swine model of cardiac arrest. Resuscitation. 2020 May;150:23-28. doi: 10.1016/j.resuscitation.2020.02.023. Epub 2020 Feb 27.
PubMed 32114071Lurie KG, Nemergut EC, Yannopoulos D, Sweeney M. The Physiology of Cardiopulmonary Resuscitation. Anesth Analg. 2016 Mar;122(3):767-783. doi: 10.1213/ANE.0000000000000926.
PubMed 26562060Moore JC, Pepe PE, Scheppke KA, Lick C, Duval S, Holley J, Salverda B, Jacobs M, Nystrom P, Quinn R, Adams PJ, Hutchison M, Mason C, Martinez E, Mason S, Clift A, Antevy PM, Coyle C, Grizzard E, Garay S, Crowe RP, Lurie KG, Debaty GP, Labarere J. Head and thorax elevation during cardiopulmonary resuscitation using circulatory adjuncts is associated with improved survival. Resuscitation. 2022 Oct;179:9-17. doi: 10.1016/j.resuscitation.2022.07.039. Epub 2022 Aug 4.
PubMed 35933057Tang W, Weil MH, Noc M, Sun S, Gazmuri RJ, Bisera J. Augmented efficacy of external CPR by intermittent occlusion of the ascending aorta. Circulation. 1993 Oct;88(4 Pt 1):1916-21. doi: 10.1161/01.cir.88.4.1916.
PubMed 8403337Sesma J, Labandeira J, Sara MJ, Espila JL, Arteche A, Saez MJ. Effect of intra-aortic occlusion balloon in external thoracic compressions during CPR in pigs. Am J Emerg Med. 2002 Sep;20(5):453-62. doi: 10.1053/ajem.2002.32627.
PubMed 12216044Daley J, Morrison JJ, Sather J, Hile L. The role of resuscitative endovascular balloon occlusion of the aorta (REBOA) as an adjunct to ACLS in non-traumatic cardiac arrest. Am J Emerg Med. 2017 May;35(5):731-736. doi: 10.1016/j.ajem.2017.01.010. Epub 2017 Jan 12.
PubMed 28117180Olsen MH, Olesen ND, Karlsson M, Holmlov T, Sondergaard L, Boutelle M, Mathiesen T, Moller K. Randomized blinded trial of automated REBOA during CPR in a porcine model of cardiac arrest. Resuscitation. 2021 Mar;160:39-48. doi: 10.1016/j.resuscitation.2021.01.010. Epub 2021 Jan 19.
PubMed 33482264Mazzoli CA, Chiarini V, Coniglio C, Lupi C, Tartaglione M, Gamberini L, Semeraro F, Gordini G. Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) in Non-Traumatic Cardiac Arrest: A Narrative Review of Known and Potential Physiological Effects. J Clin Med. 2022 Jan 29;11(3):742. doi: 10.3390/jcm11030742.
PubMed 35160193
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06537492
- Acronym / sponsor ID
- GRAVITY2 / 38RC23.0224
- Conditions
- Heart Arrest, Cardiac Arrest, Out-Of-Hospital, Cardiopulmonary Arrest, Cardiopulmonary Resuscitation
- Keywords
- Resuscitative endovascular balloon, Head-up cardiopulmonary resuscitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Oct 2024 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 5 Aug 2024 (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.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| REBOA | Experimental | Procedure: REBOA, Device: Head-Up Cardiopulmonary Resuscitation (AHUP-CPR), Device: Mechanical Chest Compression Device with Active Chest Decompression, Device: Impedance Threshold DeviceIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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).
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 |
|---|---|---|
| REBOAThe 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. | Procedure or surgery | REBOA |
| 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 | REBOA |
| Mechanical Chest Compression Device with Active Chest DecompressionAlso: ACDIn addition to head and thorax elevation, mechanical chest compression will be performed with active chest compression-decompression using a specific mechanical chest compression device. | Device | REBOA |
| Impedance Threshold DeviceAlso: ITDIn addition to REBOA, AHUP-CPR and ACD, an impedance threshold device will be used with a dedicated device. | Device | REBOA |
Primary outcome
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
17 secondary outcomes
End-Tidal CO2 (EtCO2)
Time frame: Baseline
Compression arterial pressure (CP)
Time frame: Baseline
Decompression arterial pressure (DAP)
Time frame: Baseline
Brain regional O2 saturation (rSO2)
Time frame: Baseline
Return to spontaneous circulation (ROSC).
Time frame: Baseline, 30-day, 3 months
Patients discharged alive.
Time frame: 30-day
Survival
Time frame: 30-day, 3 months
Neurological status
Time frame: 30-day, 3 months
REBOA Placement
Time frame: Baseline
Blood vessel damage
Time frame: 30-day
Arterial thromboembolism
Time frame: 30-day
Lower extremity amputation
Time frame: 30-day
Renal failure
Time frame: 30-day
Lower extremity paralysis
Time frame: 30-day
Ventilatory parameter: flow
Time frame: Out-of-hospital care
Ventilatory parameter: tidal volume
Time frame: Out-of-hospital care
Ventilatory parameter: airway pressure
Time frame: Out-of-hospital care
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2024.
- Background: PubMed 34454687Perkins GD, Callaway CW, Haywood K, Neumar RW, Lilja G, Rowland MJ, Sawyer KN, Skrifvars MB, Nolan JP. Brain injury after cardiac arrest. Lancet. 2021 Oct 2;398(10307):1269-1278. doi: 10.1016/S0140-6736(21)00953-3. Epub 2021 Aug 26.
- Background: PubMed 33385469Duhem H, Moore JC, Rojas-Salvador C, Salverda B, Lick M, Pepe P, Labarere J, Debaty G, Lurie KG. Improving post-cardiac arrest cerebral perfusion pressure by elevating the head and thorax. Resuscitation. 2021 Feb;159:45-53. doi: 10.1016/j.resuscitation.2020.12.016. Epub 2020 Dec 29.
- Background: PubMed 26905388Ryu HH, Moore JC, Yannopoulos D, Lick M, McKnite S, Shin SD, Kim TY, Metzger A, Rees J, Tsangaris A, Debaty G, Lurie KG. The Effect of Head Up Cardiopulmonary Resuscitation on Cerebral and Systemic Hemodynamics. Resuscitation. 2016 May;102:29-34. doi: 10.1016/j.resuscitation.2016.01.033. Epub 2016 Feb 22.
- Background: PubMed 33027619Moore JC, Salverda B, Rojas-Salvador C, Lick M, Debaty G, G Lurie K. Controlled sequential elevation of the head and thorax combined with active compression decompression cardiopulmonary resuscitation and an impedance threshold device improves neurological survival in a porcine model of cardiac arrest. Resuscitation. 2021 Jan;158:220-227. doi: 10.1016/j.resuscitation.2020.09.030. Epub 2020 Oct 4.
- Background: PubMed 32114071Moore JC, Salverda B, Lick M, Rojas-Salvador C, Segal N, Debaty G, Lurie KG. Controlled progressive elevation rather than an optimal angle maximizes cerebral perfusion pressure during head up CPR in a swine model of cardiac arrest. Resuscitation. 2020 May;150:23-28. doi: 10.1016/j.resuscitation.2020.02.023. Epub 2020 Feb 27.
- Background: PubMed 26562060Lurie KG, Nemergut EC, Yannopoulos D, Sweeney M. The Physiology of Cardiopulmonary Resuscitation. Anesth Analg. 2016 Mar;122(3):767-783. doi: 10.1213/ANE.0000000000000926.
- Background: PubMed 35933057Moore JC, Pepe PE, Scheppke KA, Lick C, Duval S, Holley J, Salverda B, Jacobs M, Nystrom P, Quinn R, Adams PJ, Hutchison M, Mason C, Martinez E, Mason S, Clift A, Antevy PM, Coyle C, Grizzard E, Garay S, Crowe RP, Lurie KG, Debaty GP, Labarere J. Head and thorax elevation during cardiopulmonary resuscitation using circulatory adjuncts is associated with improved survival. Resuscitation. 2022 Oct;179:9-17. doi: 10.1016/j.resuscitation.2022.07.039. Epub 2022 Aug 4.
- Background: PubMed 8403337Tang W, Weil MH, Noc M, Sun S, Gazmuri RJ, Bisera J. Augmented efficacy of external CPR by intermittent occlusion of the ascending aorta. Circulation. 1993 Oct;88(4 Pt 1):1916-21. doi: 10.1161/01.cir.88.4.1916.
- Background: PubMed 12216044Sesma J, Labandeira J, Sara MJ, Espila JL, Arteche A, Saez MJ. Effect of intra-aortic occlusion balloon in external thoracic compressions during CPR in pigs. Am J Emerg Med. 2002 Sep;20(5):453-62. doi: 10.1053/ajem.2002.32627.
- Background: PubMed 28117180Daley J, Morrison JJ, Sather J, Hile L. The role of resuscitative endovascular balloon occlusion of the aorta (REBOA) as an adjunct to ACLS in non-traumatic cardiac arrest. Am J Emerg Med. 2017 May;35(5):731-736. doi: 10.1016/j.ajem.2017.01.010. Epub 2017 Jan 12.
- Background: PubMed 33482264Olsen MH, Olesen ND, Karlsson M, Holmlov T, Sondergaard L, Boutelle M, Mathiesen T, Moller K. Randomized blinded trial of automated REBOA during CPR in a porcine model of cardiac arrest. Resuscitation. 2021 Mar;160:39-48. doi: 10.1016/j.resuscitation.2021.01.010. Epub 2021 Jan 19.
- Background: PubMed 35160193Mazzoli CA, Chiarini V, Coniglio C, Lupi C, Tartaglione M, Gamberini L, Semeraro F, Gordini G. Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) in Non-Traumatic Cardiac Arrest: A Narrative Review of Known and Potential Physiological Effects. J Clin Med. 2022 Jan 29;11(3):742. doi: 10.3390/jcm11030742.
- Individual participant dataSharing planned: Yes. Study protocol will be submitted for publication
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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.
Guillaume Pr Debaty, MD, PhD principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing REBOA, Head-Up Cardiopulmonary Resuscitation (AHUP-CPR) and Mechanical Chest Compression Device with Active Chest Decompression in people with Heart Arrest and Cardiac Arrest, Out-Of-Hospital, run by University Hospital, Grenoble at 1 site in France.
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 5 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: status not confirmed, as of the sponsor's last update on 5 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mandzo Aida (0476766816 ext. +33, amandzo@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Arterial Pressure (MAP) (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06537492, which also lists 12 linked publications.
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 5 Aug 2024.