Condition category
Not Applicable
Date applied
16/12/2013
Date assigned
21/01/2014
Last edited
21/01/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Ambulance services must perform resuscitation in accordance to the international guidelines. There are several (resuscitation) tools available that are supposed to improve resuscitation. Quality of cardiopulmonary resuscitation (CPR) and safety for nurse paramedics led to the implementation of the Lund University Cardiac Assist System (LUCAS) and the Boussignac endotracheal tube by the Regional Ambulance Service Hollands Midden (RAVHM) in the Leiden Hollands-Midden region in The Netherlands. The LUCAS is a pneumatic chest compression device that provides chest compressions in accordance to the guidelines of the International Liaison Committee on Resuscitation (ILCOR). The Boussignac tube is an endotracheal tube that gives a continuous flow of oxygen and generates a positive airway pressure during LUCAS resuscitation. In rural areas it will usually take a long time to get an ambulance to the patient. For this reason we also organized a system in which trained police and firefighters will be sent to the scene of a resuscitation in order to start early CPR before the ambulance arrives on scene as well.
The aim of the study is to examine the preclinical applicability of the LUCAS in combination with the Boussignac tube, the rate of return of spontaneous circulation (ROSC) on arrival at the emergency room and the effects of police and firefighters as first responders.

Who can participate?
All resuscitation patients in the Leiden who need chest compressions and/or defibrillation.

What does the study involve?
This is a observational study in which we will observe the application of LUCAS and the Boussignac tube in pre-hospital resuscitation.

What are the possible benefits and risks of participating?
Resuscitation will be performed according to the latest guidelines. All patients will benefit from the continuous, almost not interrupted chest compressions and ventilation. Patients in rural areas where the system of police and firefighter first responders is operational, will benefit from an earlier start of the resuscitation. There are no risks to be expected.

Where is the study run from?
The study will run from the Regional Ambulance Service Hollands Midden, The Netherlands.

When is the study starting and how long is it expected to run for?
The study started in November 2011 and ran until December 2013.

Who is funding the study?
Regional Ambulance Service Hollands-Midden, The Netherlands.

Who is the main contact?
Mr Jan Bosch, study coordinator
jbosch@ravhm.nl

Trial website

Contact information

Type

Scientific

Primary contact

Dr J. Nooij

ORCID ID

Contact details

Postbus 121
Leiden
2300 AC
Netherlands
+31 (0) 71 5730050
jdenooij@ravhm.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Prospective single-center observational study of the applicability of the Lund University Cardiac Assist System (LUCAS) in combination with the Boussignac tube and the return of spontaneous circulation (ROSC) rates

Acronym

RHM

Study hypothesis

The study should provide insight into the preclinical feasibility of the chosen tools and the ROSC rate on arrival at an emergency room. Second, the role of the automated external defibrillator (AED), bystander cardiopulmonary resuscitation (CPR), (un)witnessed (monitored) arrest and the initial arrhythmia in the ROSC rate will be described. We will investigate the contribution of first responder fire and police departments to the percentage of resuscitation patients who have achieved ROSC on arrival on scene of the ambulance and on arrival at the hospital.

Ethics approval

Ethics Board Leiden University Medical Center, 21/07/2011, P11.114

Study design

Prospective single-center observational study

Primary study design

Observational

Secondary study design

Single-centre

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Collapse, CPR, ambulance services, ROSC

Intervention

This is a observational study in which we will observe the application of LUCAS and the Boussignac tube in pre-hospital resuscitation. We will look at: ambulance and bystander delay; ROSC after use of an Automated External Defibrillator (AED) and bystander CPR; ROSC at witnessed, monitored witnessed and unwitnessed arrest. The observation timeline starts with the call to the emergency medical dispatcher and ends at arriving at the emergency room.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Return of spontaneous circulation (ROSC) of a resucitated patient on arrival at the emergency room

Secondary outcome measures

1. Application of LUCAS and the Boussignac tube
2. Ambulance and bystander delay
3. ROSC after use of an Automated External Defibrillator (AED) and bystander/police/fire department CPR
4. ROSC at witnessed, monitored witnessed and unwitnessed arrest
5. ROSC per initial rhythm (disorder)/security/complications/awareness monitoring

Overall trial start date

23/11/2011

Overall trial end date

31/12/2013

Reason abandoned

Eligibility

Participant inclusion criteria

500 consecutive resuscitation patients without age or gender discrimination

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

500

Participant exclusion criteria

1. Do-not-attempt-resuscitation (DNAR) order
2. Medically futile

Recruitment start date

23/11/2011

Recruitment end date

31/12/2013

Locations

Countries of recruitment

Netherlands

Trial participating centre

Postbus 121
Leiden
2300 AC
Netherlands

Sponsor information

Organisation

Regional Ambulance Service Hollands Midden (Regionale Ambulance Voorziening Hollands Midden [RAVHM])

Sponsor details

Postbus 121
Leiden
2300 AC
Netherlands
+31 (0) 71 5730050
jbosch@ravhm.nl

Sponsor type

Hospital/treatment centre

Website

http://www.ravhm.nl/

Funders

Funder type

Hospital/treatment centre

Funder name

Regional Ambulance Service Hollands Midden (Regionale Ambulance Voorziening Hollands Midden [RAVHM]) (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes