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Completed

NCT Number: NCT01745926

Implementation of LUCAS 2 in Helicopter Rescue in South Tyrol

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Eurac research

Bolzano, BZ, 39100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MECHANICAL CHEST COMPRESSION

Device

Other names: LUCAS2

Primary outcomes

  1. Time from arrival of rescue team to start of mechanical compressions

    Time frame: assessed immediatly after the operation is concluded

  2. Presence of abdominal or thoracic lesions caused by automated chest compressor

    Time frame: Assessed at clinical examination during hospital stay (day 1 to day 30) or autopsy

Secondary outcomes

  1. Mean arterial pressure

    Time frame: At hospital arrival (expected between 5 minutes and 1 hour from start CPR)

  2. End-tidal expiratory pCO2

    Time frame: At hospital arrival (expected between 5 minutes and 1 hour from start CPR)

  3. Return of spontaneous circulation

    Time frame: Could be each moment during CPR

  4. Arterial pO2

    Time frame: At hospital arrival (expected between 5 minutes and 1 hour from start CPR)

  5. Arterial pCO2

    Time frame: At hospital arrival (expected between 5 minutes and 1 hour from start CPR)

Sponsors and collaborators

Lead sponsor

Institute of Mountain Emergency Medicine

Other

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Dec 10, 2012
Registry last updated
Jul 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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