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Implementation of LUCAS 2 in Helicopter Rescue in South Tyrol

NCT ID: NCT01745926

Last Updated: 2019-07-24

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

Total Enrollment

18 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-04-30

Study Completion Date

2016-03-31

Brief Summary

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Cardiopulmonary resuscitation (CPR) is used to maintain adequate perfusion of vital organs in cardiac arrest patients and is fundamental for the neurological outcome and survival of these individuals. Unfortunately, the quality of CPR may be inadequate due largely to ineffective chest compressions resulting from rescuer fatigue and interruptions in compressions. The LUCAS device (Lund University Cardiopulmonary Assist System, Jolife, Lund, Sweden), introduced in 2002, is the most extensively tested and applied automated alternative to manual CPR for in-hospital care of cardiac arrest patients and during ambulance transfer; the feasibility of application of this device in helicopter emergency medical service (HEMS) operations, however, has never been addressed. The objective of this project is to equip the three active rescue helicopters in South Tyrol with the LUCAS 2 mechanical chest compression device to answer the question: What is the feasibility and efficiency of using this device for prolonged CPR in cardiac arrest patients requiring CPR during HEMS rescue operations and transport?

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Detailed Description

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This is a non-controlled, observational study. Physiological endpoints: MAP (mean arterial pressure); etCO2 (end-tidal expiratory pCO2); ROSC (return of spontaneous circulation); PaO2 (arterial pO2); PaCO2 (arterial pCO2); endpoints to assess feasibility: time from arrival to start of mechanical compressions, problems during transfer into the helicopter and in-field manoeuvers, problems with application of device, problems with patient transfer to hospital premises, hands-off time, personnel requirements.

Conditions

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Cardiac Arrest

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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CPR

MECHANICAL CHEST COMPRESSION

MECHANICAL CHEST COMPRESSION

Intervention Type DEVICE

Interventions

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MECHANICAL CHEST COMPRESSION

Intervention Type DEVICE

Other Intervention Names

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LUCAS2

Eligibility Criteria

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Inclusion Criteria

* cardiac arrest with indication of CPR
* informed consent for those regaining legal competence

Exclusion Criteria

* declaration of death on site
* contraindications of using the device
* age \<18 y
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute of Mountain Emergency Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hermann Brugger, Prof

Role: STUDY_DIRECTOR

Institute of Mountain Emergency Medicine

Locations

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Eurac research

Bolzano, BZ, Italy

Site Status

Countries

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Italy

Other Identifiers

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V/15/11

Identifier Type: -

Identifier Source: org_study_id

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