Head-up Position and High Quality Cardiopulmonary Resuscitation in OHCA (GRAVITY)

Grenoble Alpes University Hospital Center (CHU)

Status: Completed

Conditions: Cardiac Arrest

Treatments: Device: Head UP Position; Device: New Automated CPR; Device: Impedance Threshold Device

Study type: Interventional

Funder types: Other

Identifiers

NCT03996616

GRAVITY

Details and patient eligibility

About

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.

Full 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.

Enrollment: 126 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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126 participants in 2 patient groups

Control Group

No Intervention group

Description:

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 group

Description:

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)

Treatment:

Device: New Automated CPR

Device: Impedance Threshold Device

Device: Head UP Position