Head-up Position and High Quality Cardiopulmonary Resuscitation in OHCA

NCT03996616 | Completed DMC

• 1 other identifier: GRAVITY
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 2

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.

Conditions

Cardiac Arrest

Keywords

Cardiac Arrest; Cardiopulmonary Resuscitation; Head-up position

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 0

Secondary Outcomes (29)

• Return of spontaneous circulation (ROSC)

  Day 0

• Alive at hospital admission

  Day 0

• Survival to hospital discharge

  up to 30 days

• Survival at 30 days

  30 days

• Neurological functional status

  Day 30

Study Arms (2)

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)

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

Interventions

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.

Assigned Intervention

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.

Assigned Intervention

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).

Assigned Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (2)

SAMU 38

Grenoble, Isère, 38000, France

Location

SAMU 54 - CHU Nancy

Nancy, Meurthe-et-Moselle, 54000, France

Location

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Monique Sorentino

  CHU Grenoble Alpes

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, quasi-experimental, controlled, pre- and post-intervention trial, using a difference-in-differences design and involving two study sites

Study Record Dates

• First Submitted: June 17, 2019
• First Posted: June 25, 2019
• Study Start: October 9, 2019
• Primary Completion: October 17, 2022
• Study Completion: October 20, 2022
• Last Updated: May 18, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will be available within 6 months of study completion
• Access Criteria: Data will be available with no restriction

Locations

FR (2)