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NCT Number: NCT03996616

Head-up Position and High Quality Cardiopulmonary Resuscitation in OHCA

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.

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Key information

Conditions

Cardiac Arrest Cardiovascular Diseases Heart Arrest Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SAMU 38, Grenoble, Isère, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > 18 years old on enrollment
  • Witnessed out-of-hospital cardiac arrest

Exclusion criteria

  • 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)

Treatment and study plan

Head UP Position

Device

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 Device

Device

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 CPR

Device

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).

Primary outcomes

  1. 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.

Secondary outcomes

  1. Return of spontaneous circulation (ROSC)

    Time frame: Day 0

    Proportion of patients who's recovered a spontaneous circulation after CPR

  2. Alive at hospital admission

    Time frame: Day 0

    Vital status at hospital admission

  3. Survival to hospital discharge

    Time frame: up to 30 days

    Vital status at hospital discharge

  4. Survival at 30 days

    Time frame: 30 days

    Vital status at 30 days

  5. Neurological functional status

    Time frame: Day 30

    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

  6. First recorded rhythm

    Time frame: Day 0

    First recorded rhythm and rhythm recorded by EMS (asystole, ryhtme without pulse, ventricular fibrillation or ventricular tacycardia and spontaneous circulation)

  7. Changes in heart rhythm from ventricular fibrillation (VF)

    Time frame: Day 0

    Proportion of patients who's with changes in heart rhythm from VF to non-VF rhythm and vice versa during the EMS intervention

  8. Signs of life

    Time frame: Day 0

    Presence of agonal respirations and other signs of life (pupillary response, movement during CPR) recorded by ALS

  9. Re-arrest rates

    Time frame: Day 0

    We calculated the proportion of patients who's recovered another cardiac arrest during CPR (supported by ALS and EMS)

  10. Non-invasive arterial O2

    Time frame: Day 0

    Non-invasive arterial O2 saturation values during CPR recorded by EMS

  11. End-tidal carbon dioxide (ETCO2) after CPR initiation

    Time frame: Day 0

    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)

  12. Non-invasive cerebral oximetry (rsO2)

    Time frame: Day 0

    Non-invasive cerebral oximetry (rsO2) values during CPR repeated (i.e., within 4 minutes of CPR initiation) measures recorded by ALS and EMS intervention

  13. Left Ventricular (LV) function

    Time frame: Day 0

    LV function will be measured by echocardiography within 12 hours of ROSC at hospital

  14. Non-invasive measurement of blood pressure

    Time frame: Day 0

    Non-invasive measurement of blood (systolic, diastolic and mean blood pressure) pressure during CPR

  15. Intubation difficulty

    Time frame: Day 0

    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

  16. Neuron specific enolase

    Time frame: Day 0 and 24hours

    Serum Neuron specific enolase was measured at admission and 24h after hospital admission

  17. S100 protein

    Time frame: Day 0 and 24hours

    Serum S100 protein was measured- at admission and 24h after hospital admission

  18. Arterial Blood gases

    Time frame: Day 0

    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

  19. Serum lactate concentration

    Time frame: Day 0

    The serum lactate concentration was measured at hospital admission

  20. Serum d-dimer concentration

    Time frame: Day 0 and 24hours

    Serum d-dimer concentration was measured at 4hour and 24 hour after admission

  21. Troponin C serum concentration

    Time frame: Day 0 and 24hours

    Troponin C serum concentration was measured at 4hour and 24 hour after admission

  22. Creatinine concentration

    Time frame: Day 0 and 24hours

    Serum creatinine concentration was measured at 4hour and 24 hour after admission

  23. Transaminases concentration

    Time frame: Day 0 and 24hours

    Serum transaminases concentration (ASAT: aspartate aminotransferases and ALAT: alanine aminotransferases) were measured at 4hour and 24 hour after admission

  24. Imaging

    Time frame: 12 hours

    Head CT will be performed within 12 hours of ROSC. Analysis will include the white to gray matter ratio

  25. End-tidal carbon dioxide between witnessed and unwitnessed cardiac arrest out-of-hospital cardiac arrest

    Time frame: Day 0

    We compared the difference in maximum ETCO2 during CPR between values recorded for witnessed and unwitnessed cardiac arrest

  26. ROSC for witnessed and unwitnessed cardiac arrest

    Time frame: Day 0

    Proportion of patients who's recovered a spontaneous circulation after CPR between witnessed and unwitnessed cardiac arrest

  27. Survival to hospital admission for witnessed and unwitnessed cardiac arrest

    Time frame: Day 0

    Vital status at hospital admission between witnessed and unwitnessed cardiac arrest

  28. Survival to hospital discharge for witnessed and unwitnessed cardiac arrest

    Time frame: Up to 30 days

    Vital status at hospital discharge between witnessed and unwitnessed cardiac arrest

  29. Neurological functional status between witnessed and unwitnessed cardiac arrest

    Time frame: Up to 30 days

    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

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study 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

Acronym: GRAVITY

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jun 25, 2019
Registry last updated
May 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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