The Haemodynamic Effects of Mechanical Standard and Active Chest Compression-decompression During Out-of-hospital CPR

NCT ID: NCT02479152

Last Updated: 2017-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2017-04-30

Brief Summary

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The aim of this randomized out-of-hospital cardiopulmonary resuscitation study is to investigate haemodynamics generated by the standard mechanical external chest compression device (LUCAS™ 2) compared to a new version generating chest compressions and active decompression above the initial starting position of the suction cup (LUCAS™ 2AD).

Detailed Description

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Based on randomization patients will receive standard or active compression decompression chest compression and the haemodynamic effects will be compared.

Conditions

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Cardiac Arrest

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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LUCAS 2 AD

LUCAS 2 AD will be used for CPR

Group Type ACTIVE_COMPARATOR

LUCAS2 AD

Intervention Type DEVICE

LUCAS™ 2AD with compressions like the standard LUCAS™ 2 but added decompressions above the initial start position.

LUCAS2

LUCAS2 will be used for CPR

Group Type OTHER

LUCAS2 AD

Intervention Type DEVICE

LUCAS™ 2AD with compressions like the standard LUCAS™ 2 but added decompressions above the initial start position.

Interventions

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LUCAS2 AD

LUCAS™ 2AD with compressions like the standard LUCAS™ 2 but added decompressions above the initial start position.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Unexpected adult out-of-hospital non-traumatic cardiac arrest where an attempt of resuscitation is considered appropriate in:
* Patients 18 years or older

Exclusion Criteria

* Traumatic cardiac arrest
* Age believed to be less than 18 years
* Known pregnancy
* Victim not to be resuscitated (DNR orders)
* Internals in prison
* Included once in the study already
* To Small/Large patients
* Sustained ROSC occurring before the LUCAS™ 2 or LUCAS™ 2-AD can be applied to the patient, such that further CPR is not needed
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GE Healthcare

INDUSTRY

Sponsor Role collaborator

Physio-Control

INDUSTRY

Sponsor Role lead

Responsible Party

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Lars Wik

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lars Wik, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Oslo Universitetssykehus. Ullevål, Norway.

Locations

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Oslo University hospital

Oslo, , Norway

Site Status

Countries

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Norway

References

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Berve PO, Hardig BM, Skalhegg T, Kongsgaard H, Kramer-Johansen J, Wik L. Mechanical active compression-decompression versus standard mechanical cardiopulmonary resuscitation: A randomised haemodynamic out-of-hospital cardiac arrest study. Resuscitation. 2022 Jan;170:1-10. doi: 10.1016/j.resuscitation.2021.10.026. Epub 2021 Oct 25.

Reference Type DERIVED
PMID: 34710550 (View on PubMed)

Other Identifiers

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Protocol ID 11, March 2015

Identifier Type: -

Identifier Source: org_study_id

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