Cardiac Arrest Clinical Trial
Official title:
Implementation of LUCAS 2 in Helicopter Rescue in South Tyrol
NCT number | NCT01745926 |
Other study ID # | V/15/11 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 2013 |
Est. completion date | March 2016 |
Verified date | July 2019 |
Source | Institute of Mountain Emergency Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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?
Status | Completed |
Enrollment | 18 |
Est. completion date | March 2016 |
Est. primary completion date | March 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Italy | Eurac research | Bolzano | BZ |
Lead Sponsor | Collaborator |
---|---|
Institute of Mountain Emergency Medicine |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time from arrival of rescue team to start of mechanical compressions | assessed immediatly after the operation is concluded | ||
Primary | 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 | Mean arterial pressure | At hospital arrival (expected between 5 minutes and 1 hour from start CPR) | ||
Secondary | End-tidal expiratory pCO2 | At hospital arrival (expected between 5 minutes and 1 hour from start CPR) | ||
Secondary | Return of spontaneous circulation | Could be each moment during CPR | ||
Secondary | Arterial pO2 | At hospital arrival (expected between 5 minutes and 1 hour from start CPR) | ||
Secondary | Arterial pCO2 | At hospital arrival (expected between 5 minutes and 1 hour from start CPR) |
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