Implementation of LUCAS 2 in Helicopter Rescue in South Tyrol

Cardiac Arrest Clinical Trial

Official title:

Implementation of LUCAS 2 in Helicopter Rescue in South Tyrol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01745926
• Other study ID #: V/15/11
• Status: Completed
• Start date: April 2013
• Est. completion date: March 2016

Study information

• Verified date: July 2019
• Source: Institute of Mountain Emergency Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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?

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest

Intervention

Device:
• MECHANICAL CHEST COMPRESSION

Locations

Country	Name	City	State
Italy	Eurac research	Bolzano	BZ

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Mountain Emergency Medicine

Country where clinical trial is conducted

Italy, 

Outcome

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)