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Implementation of LUCAS 2 in Helicopter Rescue in South Tyrol

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ClinicalTrials.gov Identifier: NCT01745926
Recruitment Status : Unknown
Verified December 2012 by Institute of Mountain Emergency Medicine.
Recruitment status was:  Enrolling by invitation
First Posted : December 10, 2012
Last Update Posted : December 11, 2012
Sponsor:
Information provided by (Responsible Party):
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?

Condition or disease Intervention/treatment
Cardiac Arrest 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 [Patient Registry]
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Implementation of LUCAS 2 in Helicopter Rescue in South Tyrol
Study Start Date : April 2013
Estimated Primary Completion Date : March 2016
Estimated Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiac Arrest
U.S. FDA Resources

Group/Cohort Intervention/treatment
CPR
MECHANICAL CHEST COMPRESSION
Device: MECHANICAL CHEST COMPRESSION
Other Name: LUCAS2



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

Secondary Outcome Measures :
  1. Mean arterial pressure [ Time Frame: At hospital arrival (expected between 5 minutes and 1 hour from start CPR) ]
  2. End-tidal expiratory pCO2 [ Time Frame: At hospital arrival (expected between 5 minutes and 1 hour from start CPR) ]
  3. Return of spontaneous circulation [ Time Frame: Could be each moment during CPR ]
  4. Arterial pO2 [ Time Frame: At hospital arrival (expected between 5 minutes and 1 hour from start CPR) ]
  5. Arterial pCO2 [ Time Frame: At hospital arrival (expected between 5 minutes and 1 hour from start CPR) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients in cardiac arrest from all causes requiring CPR
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01745926


Locations
Italy
Eurac research
Bolzano, BZ, Italy, 39100
Sponsors and Collaborators
Institute of Mountain Emergency Medicine
Investigators
Study Director: Hermann Brugger, Prof Institute of Mountain Emergency Medicine

Responsible Party: Institute of Mountain Emergency Medicine
ClinicalTrials.gov Identifier: NCT01745926     History of Changes
Other Study ID Numbers: V/15/11
First Posted: December 10, 2012    Key Record Dates
Last Update Posted: December 11, 2012
Last Verified: December 2012

Additional relevant MeSH terms:
Heart Arrest
Heart Diseases
Cardiovascular Diseases