Head-up Position and High Quality Cardiopulmonary Resuscitation in OHCA

NCT03996616 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2023-05-18

No results posted yet for this study

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

Interventions

DEVICE

Head UP Position

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.

DEVICE

Impedance Threshold 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.

DEVICE

New Automated CPR

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).

Sponsors & Collaborators

  • University Hospital, Grenoble

    lead OTHER

Principal Investigators

  • Monique Sorentino · CHU Grenoble Alpes

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-09
Primary Completion
2022-10-17
Completion
2022-10-20

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03996616 on ClinicalTrials.gov