Cardiac ArrestGRAVITYNCT03996616
Head-up Position and High Quality Cardiopulmonary Resuscitation in OHCA
A study testing Head UP Position, Impedance Threshold Device and New Automated CPR in people with Cardiac Arrest, run by University Hospital, Grenoble at 2 sites in France.
Trial summary
Elevation of the head and thorax, also known as Head-up cardiopulmonary resuscitation (HUP CPR), has been studied extensively in pigs in ventricular fibrillation (VF). HUP combined with active compression decompression and impedance threshold device (ACD+ITD) CPR improves vital organ perfusion and results in a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- Head UP Position, Impedance Threshold Device and New Automated CPR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 2 sitesFrance
- Study dates
- 9 Oct 2019to 20 Oct 2022
- 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
- Age > 18 years old on enrollment
- Witnessed out-of-hospital cardiac arrest
Who cannot join
- Obvious pregnancy at inclusion
- Cardiac arrest of traumatic origin (including drowning or hanging)
- 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)
Trial locations and contacts
2 sites in 1 country.
France2 sites
SAMU 38
Grenoble, Isère, 38000
SAMU 54 - CHU Nancy
Nancy, Meurthe-et-Moselle, 54000
About this study
Official title: Head-up Position, Active Compression-decompression Mechanical Cardiopulmonary Resuscitation and Impedance Threshold Device to Improve Outcomes in Out-of-hospital Cardiac Arrest. A Multicenter Prospective Controlled Quasi-experimental Trial
Elevation of the head and thorax, also known as Head-up cardiopulmonary resuscitation (HUP CPR), has been studied extensively in pigs in ventricular fibrillation (VF). HUP combined with active compression decompression and impedance threshold device (ACD+ITD) CPR improves vital organ perfusion and results in a doubling of cerebral perfusion when compared with the same method of CPR in the flat or horizontal plane. HUP CPR enhances the drainage of venous blood from the brain, lowers central venous pressures, reduces intracranial pressures during the decompression phase of CPR, redistributes blood flow through the lungs during CPR, and may reduce brain edema. These mechanisms collectively contribute to improved blood flow and less injury to the brain during CPR. These benefits are due in large part to the effects of gravity on the physiology of HUP CPR. Importantly, HUP CPR is dependent upon a means of generating enough forward flow to adequately pump blood "uphill" to the brain.
In this proposed pilot study, CPR will be performed manually before the patient is placed on a controlled mechanical elevation device (Elegard, Minnesota Resuscitation Solutions LLC, USA). An ITD-16 (ResQPOD-16, Zoll, USA) will be placed on the patient's airway before the head is elevated. Automated CPR will be initiated as soon as feasible using a new automated CPR mechanical compression device that provides full active compression-decompression CPR (LUCAS-AD, Stryker, USA).
The proposed feasibility clinical study will be the first ever to test the fully integrated system of ACD+ITD HUP CPR.
Read the detailed description
Elevation of the head and thorax, also known as Head-up cardiopulmonary resuscitation (HUP CPR), has been studied extensively in pigs in ventricular fibrillation (VF). HUP combined with active compression decompression and impedance threshold device (ACD+ITD) CPR improves vital organ perfusion and results in a doubling of cerebral perfusion when compared with the same method of CPR in the flat or horizontal plane. HUP CPR enhances the drainage of venous blood from the brain, lowers central venous pressures, reduces intracranial pressures during the decompression phase of CPR, redistributes blood flow through the lungs during CPR, and may reduce brain edema. These mechanisms collectively contribute to improved blood flow and less injury to the brain during CPR. These benefits are due in large part to the effects of gravity on the physiology of HUP CPR. Importantly, HUP CPR is dependent upon a means of generating enough forward flow to adequately pump blood "uphill" to the brain.
Animal studies have shown that HUP CPR must be performed in a specific manner to be effective. For example, conventional standard CPR is insufficient, by itself, for effective HUP CPR. Additional means to enhance circulation are needed, such as concurrent use of the ITD and ACD CPR devices. ACD+ITD CPR alone has been shown to improve hemodynamics and survival with favorable neurologic outcome in several human randomized control trials. Animal studies have shown that HUP CPR is best with the combination of ACD+ITD CPR. Studies have shown that CPR must be initiated before elevating the head. Studies have also shown that HUP CPR is dependent upon the time it takes to elevate the head to the HUP. Elevation of the head and thorax should optimally take place over a 2-minute period of time from a flat position to the maximum head up elevation level in order to optimize cerebral perfusion pressures. Too rapid an elevation of the head and thorax can result in a reduction in cerebral arterial pressure when compared with flat CPR.
In this proposed pilot study, CPR will be performed manually before the patient is placed on a controlled mechanical elevation device (Elegard, Minnesota Resuscitation Solutions LLC, USA). An ITD-16 (ResQPOD-16, Zoll, USA) will be placed on the patient's airway before the head is elevated. Automated CPR will be initiated as soon as feasible using a new automated CPR mechanical compression device that provides full active compression-decompression CPR (LUCAS-AD, Stryker, USA).
The proposed feasibility clinical study will be the first ever to test the fully integrated system of ACD+ITD HUP CPR.
- Conditions
- Cardiac Arrest
- Being tested
- Head UP Position, Impedance Threshold Device, New Automated CPR
- Keywords
- Cardiac Arrest, Cardiopulmonary Resuscitation, Head-up position
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Head UP PositionDevice
CPR will be performed manually before the patient is placed on a controlled mechanical elevation device who raises the head and thorax, also known as the head-up position (HUP-Elegard, Minnesota Resuscitation Solutions LLC, USA).
Rescuers will perform CPR as continuously as possible during the placement of the Elegard, with a <10 second pause in chest compressions during the placement of this device. After performing (LUCAS AD + ITD CPR, see other interventions below) for 2 minutes with the head in the 'flat' position, the Elegard device will be turned on and the head will begin to rise as long as the patient is being treated with the ResQPOD-16 and the LUCAS AD. The head will be elevated to approximately 22 cm from the ground to the back of the occiput.
Impedance Threshold DeviceDevice
An an impedance threshold device ITD-16 (ResQPOD-16, Zoll, USA) will be placed on the patient's airway before the head is elevated.
New Automated CPRDevice
Automated CPR will be initiated as soon as feasible using a new automated CPR mechanical compression device that provides full active compression-decompression CPR (LUCAS-AD, Stryker, USA).
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | During the pre-intervention period, patients will receive standard CPR in the two study groups. Standard CPR will be performed according to the current guidelines. The only changes in current practice for the control will be the monitoring of EtCO2 and cerebral oxymetry as early as possible for the firefighter. ETCO2 will be recorded using a small portable ETCO2 monitor (EMMA, Masimo, USA). EMS first responders will receive a specific training in both group to use, recording, and reporting of ETCO2 value during CPR. This device has CE mark (see related CE mark and user manual). Cerebral oximetry will be recorded using a new small portable device (HR500, Nonin, USA). This device allows using an easy to use adhesive sensor with remote Bluetooth connection to a smartphone sized monitor. |
| Assigned Intervention | Active comparator | During the post-intervention period, patients assigned in the intervention group will receive the evaluated intervention (i.e., HUP and ACD-ITD CPR HUP using the 3 devices in combinations, Elegard, Lucas AD and ITD-16) Receives: Device: Head UP Position; Device: Impedance Threshold Device; Device: New Automated CPR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum End-tidal carbon dioxide (ETCO2)
The maximum value of ETCO2 during CPR before ROSC measured after a washout period of 4 positive pressure ventilations (~30 seconds with 30:2 compression: ventilation ratio) will be recorded. ETCO2 value reflects both cardiac output (CO) and pulmonary blood flow, and is an indirect indicator of coronary perfusion pressure during CPR. Levels of ETCO2 > 10-15 mmHg have been correlated with return of spontaneous circulation (ROSC) and survival in both animal and human models of cardiac arrest.
Measured: Day 0
Secondary outcomes (29)
Return of spontaneous circulation (ROSC)
Proportion of patients who's recovered a spontaneous circulation after CPR
Measured: Day 0
Alive at hospital admission
Vital status at hospital admission
Measured: Day 0
Survival to hospital discharge
Vital status at hospital discharge
Measured: up to 30 days
Survival at 30 days
Vital status at 30 days
Measured: 30 days
Neurological functional status
As measured by using the modified Rankin Scale (mRS). A score equal to 0 = no symptoms at all, A score equal to 1 = no significant disability, despite symptoms ; able to carry out all usual duties and activities A score equal to 2 = slight disability ; unable to carry out all previous activities but able to look after own affairs A score equal to 3 = moderate disability ; requiring some help, but able to walk without assistance A score equal to 4 = moderately severe disability ; unable to walk without assistance and unable to attend to own bodily needs without assistance A score equal to 5 = severe disability ; bedridden, incontinent and requiring constant nursing care and attention We considered to a score less or equal to 3 will be considered as favourable neurologic outcome
Measured: Day 30
First recorded rhythm
First recorded rhythm and rhythm recorded by EMS (asystole, ryhtme without pulse, ventricular fibrillation or ventricular tacycardia and spontaneous circulation)
Measured: Day 0
Changes in heart rhythm from ventricular fibrillation (VF)
Proportion of patients who's with changes in heart rhythm from VF to non-VF rhythm and vice versa during the EMS intervention
Measured: Day 0
Signs of life
Presence of agonal respirations and other signs of life (pupillary response, movement during CPR) recorded by ALS
Measured: Day 0
Re-arrest rates
We calculated the proportion of patients who's recovered another cardiac arrest during CPR (supported by ALS and EMS)
Measured: Day 0
Non-invasive arterial O2
Non-invasive arterial O2 saturation values during CPR recorded by EMS
Measured: Day 0
End-tidal carbon dioxide (ETCO2) after CPR initiation
We compared the difference in ETCO2 values between baseline (i.e., within 2 minutes of CPR initiation) and repeated (i.e., within 4 minutes of CPR initiation) measures during the CPR (recorded by ALS and EMS intervention)
Measured: Day 0
Non-invasive cerebral oximetry (rsO2)
Non-invasive cerebral oximetry (rsO2) values during CPR repeated (i.e., within 4 minutes of CPR initiation) measures recorded by ALS and EMS intervention
Measured: Day 0
Left Ventricular (LV) function
LV function will be measured by echocardiography within 12 hours of ROSC at hospital
Measured: Day 0
Non-invasive measurement of blood pressure
Non-invasive measurement of blood (systolic, diastolic and mean blood pressure) pressure during CPR
Measured: Day 0
Intubation difficulty
Intubation difficulty assessed by the Intubation Difficulty Scale score. Score equal at 0 will be considered to easy intubation, score between 0 and 5 will be considered to slight difficulty, score more than 5 will be considered to moderate to major difficulty and score equal to infinite will be considered to impossible intubation
Measured: Day 0
Neuron specific enolase
Serum Neuron specific enolase was measured at admission and 24h after hospital admission
Measured: Day 0 and 24hours
S100 protein
Serum S100 protein was measured- at admission and 24h after hospital admission
Measured: Day 0 and 24hours
Arterial Blood gases
Arterial blood gases (PaO2 partial pressure of oxygen, PCO2 partial pressure of cardon dioxide, pH, HCO3- bicarbonates and SaO2 oxygen saturation) were measured at hospital admission
Measured: Day 0
Serum lactate concentration
The serum lactate concentration was measured at hospital admission
Measured: Day 0
Serum d-dimer concentration
Serum d-dimer concentration was measured at 4hour and 24 hour after admission
Measured: Day 0 and 24hours
Troponin C serum concentration
Troponin C serum concentration was measured at 4hour and 24 hour after admission
Measured: Day 0 and 24hours
Creatinine concentration
Serum creatinine concentration was measured at 4hour and 24 hour after admission
Measured: Day 0 and 24hours
Transaminases concentration
Serum transaminases concentration (ASAT: aspartate aminotransferases and ALAT: alanine aminotransferases) were measured at 4hour and 24 hour after admission
Measured: Day 0 and 24hours
Imaging
Head CT will be performed within 12 hours of ROSC. Analysis will include the white to gray matter ratio
Measured: 12 hours
End-tidal carbon dioxide between witnessed and unwitnessed cardiac arrest out-of-hospital cardiac arrest
We compared the difference in maximum ETCO2 during CPR between values recorded for witnessed and unwitnessed cardiac arrest
Measured: Day 0
ROSC for witnessed and unwitnessed cardiac arrest
Proportion of patients who's recovered a spontaneous circulation after CPR between witnessed and unwitnessed cardiac arrest
Measured: Day 0
Survival to hospital admission for witnessed and unwitnessed cardiac arrest
Vital status at hospital admission between witnessed and unwitnessed cardiac arrest
Measured: Day 0
Survival to hospital discharge for witnessed and unwitnessed cardiac arrest
Vital status at hospital discharge between witnessed and unwitnessed cardiac arrest
Measured: Up to 30 days
Neurological functional status between witnessed and unwitnessed cardiac arrest
As measured by using the modified Rankin Scale (mRS). A score equal to 0 = no symptoms at all, A score equal to 1 = no significant disability, despite symptoms ; able to carry out all usual duties and activities A score equal to 2 = slight disability ; unable to carry out all previous activities but able to look after own affairs A score equal to 3 = moderate disability ; requiring some help, but able to walk without assistance A score equal to 4 = moderately severe disbility ; unable to walk without assistance and unable to attend to own bodily needs without assistance A score equal to 5 = severe disability ; bedridden, incontinent and requiring constant nursing care and attention We consired to a score less or equal to 3 will be considered as favourable neurologic outcome
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2019
- Study start9 Oct 2019
- Primary completion17 Oct 2022
- Study completion20 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, quasi-experimental, controlled, pre- and post-intervention trial, using a difference-in-differences design and involving two study sites
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Monique Sorentino, Study director, CHU Grenoble Alpes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03996616
- Sponsor's protocol ID
- GRAVITY
- Acronym
- GRAVITY
- Status last verified
- May 2023
- First submitted
- 17 Jun 2019
- Last updated
- 18 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol will be submitted for publication. IPD will be shared with other researcher
Publications
Debaty G, Segond N, Duhem H, Crespi C, Behouche A, Boeuf J, Sanchez C, Chouihed T, Moore J, Lurie K, Labarere J. Comparison of end tidal CO2 levels between automated head up and conventional cardiopulmonary resuscitation: A pre-post intervention trial. Resuscitation. 2024 Nov;204:110406. doi: 10.1016/j.resuscitation.2024.110406. Epub 2024 Oct 2.
PubMed 39366543
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Head-up Position, Active Compression-decompression Mechanical Cardiopulmonary Resuscitation and Impedance Threshold Device to Improve Outcomes in Out-of-hospital Cardiac Arrest. A Multicenter Prospective Controlled Quasi-experimental Trial
- ClinicalTrials.gov ID
- NCT03996616
- Acronym / sponsor ID
- GRAVITY / GRAVITY
- Conditions
- Cardiac Arrest
- Keywords
- Cardiac Arrest, Cardiopulmonary Resuscitation, Head-up position
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 9 Oct 2019 (actual)
- Primary completion
- 17 Oct 2022 (actual)
- Study completion
- 20 Oct 2022 (actual)
- First posted
- 25 Jun 2019 (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.
Elevation of the head and thorax, also known as Head-up cardiopulmonary resuscitation (HUP CPR), has been studied extensively in pigs in ventricular fibrillation (VF). HUP combined with active compression decompression and impedance threshold device (ACD+ITD) CPR improves vital organ perfusion and results in a doubling of cerebral perfusion when compared with the same method of CPR in the flat or horizontal plane. HUP CPR enhances the drainage of venous blood from the brain, lowers central venous pressures, reduces intracranial pressures during the decompression phase of CPR, redistributes blood flow through the lungs during CPR, and may reduce brain edema. These mechanisms collectively contribute to improved blood flow and less injury to the brain during CPR. These benefits are due in large part to the effects of gravity on the physiology of HUP CPR. Importantly, HUP CPR is dependent upon a means of generating enough forward flow to adequately pump blood "uphill" to the brain.
In this proposed pilot study, CPR will be performed manually before the patient is placed on a controlled mechanical elevation device (Elegard, Minnesota Resuscitation Solutions LLC, USA). An ITD-16 (ResQPOD-16, Zoll, USA) will be placed on the patient's airway before the head is elevated. Automated CPR will be initiated as soon as feasible using a new automated CPR mechanical compression device that provides full active compression-decompression CPR (LUCAS-AD, Stryker, USA).
The proposed feasibility clinical study will be the first ever to test the fully integrated system of ACD+ITD HUP CPR.
Detailed description
Elevation of the head and thorax, also known as Head-up cardiopulmonary resuscitation (HUP CPR), has been studied extensively in pigs in ventricular fibrillation (VF). HUP combined with active compression decompression and impedance threshold device (ACD+ITD) CPR improves vital organ perfusion and results in a doubling of cerebral perfusion when compared with the same method of CPR in the flat or horizontal plane. HUP CPR enhances the drainage of venous blood from the brain, lowers central venous pressures, reduces intracranial pressures during the decompression phase of CPR, redistributes blood flow through the lungs during CPR, and may reduce brain edema. These mechanisms collectively contribute to improved blood flow and less injury to the brain during CPR. These benefits are due in large part to the effects of gravity on the physiology of HUP CPR. Importantly, HUP CPR is dependent upon a means of generating enough forward flow to adequately pump blood "uphill" to the brain.
Animal studies have shown that HUP CPR must be performed in a specific manner to be effective. For example, conventional standard CPR is insufficient, by itself, for effective HUP CPR. Additional means to enhance circulation are needed, such as concurrent use of the ITD and ACD CPR devices. ACD+ITD CPR alone has been shown to improve hemodynamics and survival with favorable neurologic outcome in several human randomized control trials. Animal studies have shown that HUP CPR is best with the combination of ACD+ITD CPR. Studies have shown that CPR must be initiated before elevating the head. Studies have also shown that HUP CPR is dependent upon the time it takes to elevate the head to the HUP. Elevation of the head and thorax should optimally take place over a 2-minute period of time from a flat position to the maximum head up elevation level in order to optimize cerebral perfusion pressures. Too rapid an elevation of the head and thorax can result in a reduction in cerebral arterial pressure when compared with flat CPR.
In this proposed pilot study, CPR will be performed manually before the patient is placed on a controlled mechanical elevation device (Elegard, Minnesota Resuscitation Solutions LLC, USA). An ITD-16 (ResQPOD-16, Zoll, USA) will be placed on the patient's airway before the head is elevated. Automated CPR will be initiated as soon as feasible using a new automated CPR mechanical compression device that provides full active compression-decompression CPR (LUCAS-AD, Stryker, USA).
The proposed feasibility clinical study will be the first ever to test the fully integrated system of ACD+ITD HUP CPR.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, quasi-experimental, controlled, pre- and post-intervention trial, using a difference-in-differences design and involving two study sites
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –During the pre-intervention period, patients will receive standard CPR in the two study groups. Standard CPR will be performed according to the current guidelines. The only changes in current practice for the control will be the monitoring of EtCO2 and cerebral oxymetry as early as possible for the firefighter. ETCO2 will be recorded using a small portable ETCO2 monitor (EMMA, Masimo, USA). EMS first responders will receive a specific training in both group to use, recording, and reporting of ETCO2 value during CPR. This device has CE mark (see related CE mark and user manual). Cerebral oximetry will be recorded using a new small portable device (HR500, Nonin, USA). This device allows using an easy to use adhesive sensor with remote Bluetooth connection to a smartphone sized monitor. |
| Assigned Intervention | Active comparator | Device: Head UP Position, Device: Impedance Threshold Device, Device: New Automated CPRDuring the post-intervention period, patients assigned in the intervention group will receive the evaluated intervention (i.e., HUP and ACD-ITD CPR HUP using the 3 devices in combinations, Elegard, Lucas AD and ITD-16) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age > 18 years old on enrollment
- Witnessed out-of-hospital cardiac arrest
Key exclusion criteria (3 listed)
- Obvious pregnancy at inclusion
- Cardiac arrest of traumatic origin (including drowning or hanging)
- 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 |
|---|---|---|
| Head UP PositionCPR will be performed manually before the patient is placed on a controlled mechanical elevation device who raises the head and thorax, also known as the head-up position (HUP-Elegard, Minnesota Resuscitation Solutions LLC, USA). Rescuers will perform CPR as continuously as possible during the placement of the Elegard, with a <10 second pause in chest compressions during the placement of this device. After performing (LUCAS AD + ITD CPR, see other interventions below) for 2 minutes with the head in the 'flat' position, the Elegard device will be turned on and the head will begin to rise as long as the patient is being treated with the ResQPOD-16 and the LUCAS AD. The head will be elevated to approximately 22 cm from the ground to the back of the occiput. | Device | Assigned Intervention |
| Impedance Threshold DeviceAn an impedance threshold device ITD-16 (ResQPOD-16, Zoll, USA) will be placed on the patient's airway before the head is elevated. | Device | Assigned Intervention |
| New Automated CPRAutomated CPR will be initiated as soon as feasible using a new automated CPR mechanical compression device that provides full active compression-decompression CPR (LUCAS-AD, Stryker, USA). | Device | Assigned Intervention |
Primary outcome
Maximum End-tidal carbon dioxide (ETCO2)
Time frame: Day 0
The maximum value of ETCO2 during CPR before ROSC measured after a washout period of 4 positive pressure ventilations (~30 seconds with 30:2 compression: ventilation ratio) will be recorded. ETCO2 value reflects both cardiac output (CO) and pulmonary blood flow, and is an indirect indicator of coronary perfusion pressure during CPR. Levels of ETCO2 > 10-15 mmHg have been correlated with return of spontaneous circulation (ROSC) and survival in both animal and human models of cardiac arrest.
29 secondary outcomes
Return of spontaneous circulation (ROSC)
Time frame: Day 0
Alive at hospital admission
Time frame: Day 0
Survival to hospital discharge
Time frame: up to 30 days
Survival at 30 days
Time frame: 30 days
Neurological functional status
Time frame: Day 30
First recorded rhythm
Time frame: Day 0
Changes in heart rhythm from ventricular fibrillation (VF)
Time frame: Day 0
Signs of life
Time frame: Day 0
Re-arrest rates
Time frame: Day 0
Non-invasive arterial O2
Time frame: Day 0
End-tidal carbon dioxide (ETCO2) after CPR initiation
Time frame: Day 0
Non-invasive cerebral oximetry (rsO2)
Time frame: Day 0
Left Ventricular (LV) function
Time frame: Day 0
Non-invasive measurement of blood pressure
Time frame: Day 0
Intubation difficulty
Time frame: Day 0
Neuron specific enolase
Time frame: Day 0 and 24hours
S100 protein
Time frame: Day 0 and 24hours
Arterial Blood gases
Time frame: Day 0
Serum lactate concentration
Time frame: Day 0
Serum d-dimer concentration
Time frame: Day 0 and 24hours
Troponin C serum concentration
Time frame: Day 0 and 24hours
Creatinine concentration
Time frame: Day 0 and 24hours
Transaminases concentration
Time frame: Day 0 and 24hours
Imaging
Time frame: 12 hours
End-tidal carbon dioxide between witnessed and unwitnessed cardiac arrest out-of-hospital cardiac arrest
Time frame: Day 0
ROSC for witnessed and unwitnessed cardiac arrest
Time frame: Day 0
Survival to hospital admission for witnessed and unwitnessed cardiac arrest
Time frame: Day 0
Survival to hospital discharge for witnessed and unwitnessed cardiac arrest
Time frame: Up to 30 days
Neurological functional status between witnessed and unwitnessed cardiac arrest
Time frame: Up to 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2023.
- Derived from this study: PubMed 39366543Debaty G, Segond N, Duhem H, Crespi C, Behouche A, Boeuf J, Sanchez C, Chouihed T, Moore J, Lurie K, Labarere J. Comparison of end tidal CO2 levels between automated head up and conventional cardiopulmonary resuscitation: A pre-post intervention trial. Resuscitation. 2024 Nov;204:110406. doi: 10.1016/j.resuscitation.2024.110406. Epub 2024 Oct 2.
- Individual participant dataSharing planned: Yes. Study protocol will be submitted for publication. IPD will be shared with other researcher
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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.
Monique Sorentino study director
CHU Grenoble Alpes
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Head UP Position, Impedance Threshold Device and New Automated CPR in people with Cardiac Arrest, run by University Hospital, Grenoble at 2 sites 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 18 May 2023. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maximum End-tidal carbon dioxide (ETCO2) (time frame: Day 0). 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 NCT03996616, which also lists 1 linked publication.
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 18 May 2023.