Implementation of LUCAS 2 in Helicopter Rescue in South Tyrol

Completed

• Conditions: Cardiac Arrest

• Registration Number: NCT01745926
• Lead Sponsor: Institute of Mountain Emergency Medicine

Brief Summary

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?

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 Timeline

• Study First Submitted: 2012-12-05
• Study First Submitted QC: 2012-12-06
• Study First Posted: 2012-12-10
• Study Start: 2013-04
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-22
• Last Update Posted: 2019-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
End-tidal expiratory pCO2	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)
Mean arterial pressure	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)

Trial Locations

Locations (1)

Eurac research; 🇮🇹 Bolzano, BZ, Italy