AutoPulse Compared With Manual Technique for OHCA Patients on Outcome and CPR Process.

NCT04663009 | Completed FDA Device

• 1 other identifier: 11903
• Study Type: observational
• Target: 3,250
• Locations: 1 country
• Sites: 1

Brief Summary

The AutoPulse Resuscitation System Model 100 (ZOLL Medical Corporation, Chelmsford, MA, US) ZOLL has been used as a standard treatment for a number of subjects in this trial and granted CE marking for Europe in November of 2003. The AutoPulse device is an automated, portable, battery-powered, load-band-distributing (LDB), chest compression device, which provides chest compressions as an adjunct to performing manual cardiopulmonary resuscitation (CPR). Use of the device is intended to provide consistent chest compressions without interruption to a victim of out-of-hospital cardiac arrest (OOHCA), to reduce the impact of rescuer fatigue due to application of manual CPR, and to enable rescuers to address additional patient needs. In the present study investigators will compare electronic data generated during cardiopulmonary resuscitation stored in the different multimonitores between LDB and manual chest compressions.

Conditions

Cardiac Arrest; Out-Of-Hospital Cardiac Arrest

Keywords

survival; rosc; cpr process

Outcome Measures

Primary Outcomes (1)

• Survival

  The primary endpoint is OOHCA patient survival to hospital discharge

  through study completion, an average of 1 year

Secondary Outcomes (2)

• Short time survival

  through study completion, an average of 1 year

• CPR process outcomes

  through study completion, an average of 1 year

Study Arms (2)

Mechanical chest compression

Patients recieving LDB CPR

Device: AutoPulse

Manual chest compressions

Patients recieving manual CPR

Interventions

AutoPulse DEVICE

A band circumflex of the chest that provide chest cage compressions.

Also known as: LDB

Mechanical chest compression

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients in cardiac arrest treated by the EMS at the different sites.

You may not qualify if:

• Wards of the state
• Prisoner
• Do Not Attempt to Resuscitate (DNAR) orders
• Patients whose chest circumference is too big (\> 130 cm)
• Patients whose chest circumference is too small (\< 75 cm)
• Patients whose weight is greater than 150 Kg.
• CPR device other than LDB device.

Sponsors & Collaborators

• Lars Wik: lead
• Jon Erik Steen Hansen: collaborator
• Unai Irusta Zarandona: collaborator
• Elisabete Aramendi: collaborator
• Erik Alonso: collaborator
• Simone Savastano: collaborator
• Enrico Baldi: collaborator
• Alessandra Palo: collaborator

Study Sites (1)

Central Hospital Vestfold

Tønsberg, Norway

Location

MeSH Terms

Conditions

Heart Arrest; Out-of-Hospital Cardiac Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Lars Wik, MD, PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: December 3, 2020
• First Posted: December 10, 2020
• Study Start: December 3, 2020
• Primary Completion: December 3, 2020
• Study Completion: December 3, 2020
• Last Updated: December 14, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)