Clinical trial NCT03996616: Head-up Position and High Quality Cardiopulmonary Resuscitation in OHCA
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Arrest
Keywords: Cardiac Arrest
Cardiopulmonary Resuscitation
Head-up position
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2019-06-25
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, quasi-experimental, controlled, pre- and post-intervention trial, using a difference-in-differences design and involving two study sites
Primary purpose: OTHER

Brief 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 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Maximum End-tidal carbon dioxide (ETCO2)
timeFrame: Day 0
Secondary outcomes:
measure: Return of spontaneous circulation (ROSC)
timeFrame: Day 0
measure: Alive at hospital admission
timeFrame: Day 0
measure: Survival to hospital discharge
timeFrame: up to 30 days
measure: Survival at 30 days
timeFrame: 30 days
measure: Neurological functional status
timeFrame: Day 30
measure: First recorded rhythm
timeFrame: Day 0
measure: Changes in heart rhythm from ventricular fibrillation (VF)
timeFrame: Day 0
measure: Signs of life
timeFrame: Day 0
measure: Re-arrest rates
timeFrame: Day 0
measure: Non-invasive arterial O2
timeFrame: Day 0
measure: End-tidal carbon dioxide (ETCO2) after CPR initiation
timeFrame: Day 0
measure: Non-invasive cerebral oximetry (rsO2)
timeFrame: Day 0
measure: Left Ventricular (LV) function
timeFrame: Day 0
measure: Non-invasive measurement of blood pressure
timeFrame: Day 0
measure: Intubation difficulty
timeFrame: Day 0
measure: Neuron specific enolase
timeFrame: Day 0 and 24hours
measure: S100 protein
timeFrame: Day 0 and 24hours
measure: Arterial Blood gases
timeFrame: Day 0
measure: Serum lactate concentration
timeFrame: Day 0
measure: Serum d-dimer concentration
timeFrame: Day 0 and 24hours
measure: Troponin C serum concentration
timeFrame: Day 0 and 24hours
measure: Creatinine concentration
timeFrame: Day 0 and 24hours
measure: Transaminases concentration
timeFrame: Day 0 and 24hours
measure: Imaging
timeFrame: 12 hours
measure: End-tidal carbon dioxide between witnessed and unwitnessed cardiac arrest out-of-hospital cardiac arrest
timeFrame: Day 0
measure: ROSC for witnessed and unwitnessed cardiac arrest
timeFrame: Day 0
measure: Survival to hospital admission for witnessed and unwitnessed cardiac arrest
timeFrame: Day 0
measure: Survival to hospital discharge for witnessed and unwitnessed cardiac arrest
timeFrame: Up to 30 days
measure: Neurological functional status between witnessed and unwitnessed cardiac arrest
timeFrame: Up to 30 days
Other outcomes:
Locations:
city: Grenoble
country: France
facility: SAMU 38
state: Isère
city: Nancy
country: France
facility: SAMU 54 - CHU Nancy
state: Meurthe-et-Moselle
Study officials:
affiliation: CHU Grenoble Alpes
name: Monique Sorentino
role: STUDY_DIRECTOR
References: