Implementation of LUCAS 2 in Helicopter Rescue in South Tyrol

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Institute of Mountain Emergency Medicine
ClinicalTrials.gov Identifier:
NCT01745926
First received: December 5, 2012
Last updated: December 10, 2012
Last verified: December 2012
  Purpose

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 Intervention
Cardiac Arrest
Device: MECHANICAL CHEST COMPRESSION

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Implementation of LUCAS 2 in Helicopter Rescue in South Tyrol

Resource links provided by NLM:


Further study details as provided by Institute of Mountain Emergency Medicine:

Primary Outcome Measures:
  • Time from arrival of rescue team to start of mechanical compressions [ Time Frame: assessed immediatly after the operation is concluded ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Mean arterial pressure [ Time Frame: At hospital arrival (expected between 5 minutes and 1 hour from start CPR) ] [ Designated as safety issue: No ]
  • End-tidal expiratory pCO2 [ Time Frame: At hospital arrival (expected between 5 minutes and 1 hour from start CPR) ] [ Designated as safety issue: No ]
  • Return of spontaneous circulation [ Time Frame: Could be each moment during CPR ] [ Designated as safety issue: No ]
  • Arterial pO2 [ Time Frame: At hospital arrival (expected between 5 minutes and 1 hour from start CPR) ] [ Designated as safety issue: No ]
  • Arterial pCO2 [ Time Frame: At hospital arrival (expected between 5 minutes and 1 hour from start CPR) ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: April 2013
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
CPR
MECHANICAL CHEST COMPRESSION
Device: MECHANICAL CHEST COMPRESSION
Other Name: LUCAS2

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Institute of Mountain Emergency Medicine
ClinicalTrials.gov Identifier: NCT01745926     History of Changes
Other Study ID Numbers: V/15/11
Study First Received: December 5, 2012
Last Updated: December 10, 2012
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Heart Arrest
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 20, 2014