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Implementation of LUCAS 2 in Helicopter Rescue in South Tyrol

Implementation of LUCAS 2 in Helicopter Rescue in South Tyrol

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01745926
Enrollment
18
Registered
2012-12-10
Start date
2013-04-30
Completion date
2016-03-31
Last updated
2019-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Arrest

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.

Interventions

Sponsors

Institute of Mountain Emergency Medicine
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Time from arrival of rescue team to start of mechanical compressionsassessed immediatly after the operation is concluded
Presence of abdominal or thoracic lesions caused by automated chest compressorAssessed at clinical examination during hospital stay (day 1 to day 30) or autopsy

Secondary

MeasureTime frame
Return of spontaneous circulationCould be each moment during CPR
Mean arterial pressureAt hospital arrival (expected between 5 minutes and 1 hour from start CPR)
Arterial pCO2At hospital arrival (expected between 5 minutes and 1 hour from start CPR)
Arterial pO2At hospital arrival (expected between 5 minutes and 1 hour from start CPR)
End-tidal expiratory pCO2At hospital arrival (expected between 5 minutes and 1 hour from start CPR)

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026