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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date July 2019
Source Institute of Mountain Emergency Medicine
Contact n/a
Is FDA regulated No
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
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