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?

Study Overview

• Status: Completed
• Conditions: Cardiac Arrest
• Intervention / Treatment: Device: MECHANICAL CHEST COMPRESSION

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 18

Contacts and Locations

Study Locations

• Italy
  • BZ
    • Bolzano, BZ, Italy, 39100
      • Eurac Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients in cardiac arrest from all causes requiring CPR

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CPR; MECHANICAL CHEST COMPRESSION	Device: MECHANICAL CHEST COMPRESSION; Other Names: LUCAS2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time from arrival of rescue team to start of mechanical compressions	assessed immediatly after the operation is concluded
Presence of abdominal or thoracic lesions caused by automated chest compressor	Assessed at clinical examination during hospital stay (day 1 to day 30) or autopsy

Secondary Outcome Measures

Outcome Measure	Time Frame
Mean arterial pressure	At hospital arrival (expected between 5 minutes and 1 hour from start CPR)
End-tidal expiratory pCO2	At hospital arrival (expected between 5 minutes and 1 hour from start CPR)
Return of spontaneous circulation	Could be each moment during CPR
Arterial pO2	At hospital arrival (expected between 5 minutes and 1 hour from start CPR)
Arterial pCO2	At hospital arrival (expected between 5 minutes and 1 hour from start CPR)

Collaborators and Investigators

• Sponsor: Institute of Mountain Emergency Medicine
• Investigators: Study Director: Hermann Brugger, Prof, Institute of Mountain Emergency Medicine

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: December 5, 2012
• First Submitted That Met QC Criteria: December 6, 2012
• First Posted (Estimate): December 10, 2012

Study Record Updates

• Last Update Posted (Actual): July 24, 2019
• Last Update Submitted That Met QC Criteria: July 22, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest
• Other Study ID Numbers: V/15/11