Implementation of LUCAS 2 in Helicopter Rescue in South Tyrol

NCT01745926 | Completed DMC

• 1 other identifier: V/15/11
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

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?

Conditions

Cardiac Arrest

Outcome Measures

Primary Outcomes (2)

• Time from arrival of rescue team to start of mechanical compressions

  assessed immediatly after the operation is concluded

• 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 Outcomes (5)

• Mean arterial pressure

  At hospital arrival (expected between 5 minutes and 1 hour from start CPR)

• End-tidal expiratory pCO2

  At hospital arrival (expected between 5 minutes and 1 hour from start CPR)

• Return of spontaneous circulation

  Could be each moment during CPR

• Arterial pO2

  At hospital arrival (expected between 5 minutes and 1 hour from start CPR)

• Arterial pCO2

  At hospital arrival (expected between 5 minutes and 1 hour from start CPR)

Study Arms (1)

CPR

MECHANICAL CHEST COMPRESSION

Device: MECHANICAL CHEST COMPRESSION

Interventions

MECHANICAL CHEST COMPRESSION DEVICE

Also known as: LUCAS2

CPR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients in cardiac arrest from all causes requiring CPR

You may qualify if:

• cardiac arrest with indication of CPR
• informed consent for those regaining legal competence

You may not qualify if:

• declaration of death on site
• contraindications of using the device
• age \<18 y

Sponsors & Collaborators

• Institute of Mountain Emergency Medicine: lead

Study Sites (1)

Eurac research

Bolzano, BZ, 39100, Italy

Location

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Hermann Brugger, Prof

  Institute of Mountain Emergency Medicine

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2012
• First Posted: December 10, 2012
• Study Start: April 1, 2013
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: July 24, 2019

Record last verified: 2019-07

Locations

IT (1)