Clinical trial NCT01745926: Implementation of LUCAS 2 in Helicopter Rescue in South Tyrol
Official title: Implementation of LUCAS 2 in Helicopter Rescue in South Tyrol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Arrest
Lead sponsor: Institute of Mountain Emergency Medicine
Sponsor class: OTHER
First posted: 2012-12-10
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in cardiac arrest from all causes requiring CPR

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time from arrival of rescue team to start of mechanical compressions
timeFrame: assessed immediatly after the operation is concluded
measure: Presence of abdominal or thoracic lesions caused by automated chest compressor
timeFrame: Assessed at clinical examination during hospital stay (day 1 to day 30) or autopsy
Secondary outcomes:
measure: Mean arterial pressure
timeFrame: At hospital arrival (expected between 5 minutes and 1 hour from start CPR)
measure: End-tidal expiratory pCO2
timeFrame: At hospital arrival (expected between 5 minutes and 1 hour from start CPR)
measure: Return of spontaneous circulation
timeFrame: Could be each moment during CPR
measure: Arterial pO2
timeFrame: At hospital arrival (expected between 5 minutes and 1 hour from start CPR)
measure: Arterial pCO2
timeFrame: At hospital arrival (expected between 5 minutes and 1 hour from start CPR)
Other outcomes:
Locations:
city: Bolzano
country: Italy
facility: Eurac research
state: BZ
Study officials:
affiliation: Institute of Mountain Emergency Medicine
name: Hermann Brugger, Prof
role: STUDY_DIRECTOR
References: