ISRCTN ISRCTN42987115
DOI https://doi.org/10.1186/ISRCTN42987115
Secondary identifying numbers N/A
Submission date
16/12/2013
Registration date
21/01/2014
Last edited
09/08/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr J. Nooij
Scientific

Postbus 121
Leiden
2300 AC
Netherlands

Phone +31 (0) 71 5730050
Email jdenooij@ravhm.nl

Study information

Study designProspective single-center observational study
Primary study designObservational
Secondary study designSingle-centre
Study setting(s)Hospital
Study typeScreening
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleProspective 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
Study acronymRHM
Study objectivesThe 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(s)Ethics Board Leiden University Medical Center, 21/07/2011, P11.114
Health condition(s) or problem(s) studiedCollapse, CPR, ambulance services, ROSC
InterventionThis 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 typeOther
Primary outcome measureReturn of spontaneous circulation (ROSC) of a resucitated patient on arrival at the emergency room
Secondary outcome measures1. 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 study start date23/11/2011
Completion date31/12/2013

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants500
Total final enrolment433
Key inclusion criteria500 consecutive resuscitation patients without age or gender discrimination
Key exclusion criteria1. Do-not-attempt-resuscitation (DNAR) order
2. Medically futile
Date of first enrolment23/11/2011
Date of final enrolment31/12/2013

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Postbus 121
Leiden
2300 AC
Netherlands

Sponsor information

Regional Ambulance Service Hollands Midden (Regionale Ambulance Voorziening Hollands Midden [RAVHM])
Hospital/treatment centre

Postbus 121
Leiden
2300 AC
Netherlands

Phone +31 (0) 71 5730050
Email jbosch@ravhm.nl
Website http://www.ravhm.nl/

Funders

Funder type

Hospital/treatment centre

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/07/2019 09/08/2019 Yes No

Editorial Notes

09/08/2019: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.