Resuscitation Hollands-Midden (RHM) study
ISRCTN | ISRCTN42987115 |
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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
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
Scientific
Postbus 121
Leiden
2300 AC
Netherlands
Phone | +31 (0) 71 5730050 |
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jdenooij@ravhm.nl |
Study information
Study design | Prospective single-center observational study |
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Primary study design | Observational |
Secondary study design | Single-centre |
Study setting(s) | Hospital |
Study type | Screening |
Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
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 |
Study acronym | RHM |
Study objectives | 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(s) | Ethics Board Leiden University Medical Center, 21/07/2011, P11.114 |
Health condition(s) or problem(s) studied | 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 |
Primary outcome measure | 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 study start date | 23/11/2011 |
Completion date | 31/12/2013 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 500 |
Total final enrolment | 433 |
Key inclusion criteria | 500 consecutive resuscitation patients without age or gender discrimination |
Key exclusion criteria | 1. Do-not-attempt-resuscitation (DNAR) order 2. Medically futile |
Date of first enrolment | 23/11/2011 |
Date of final enrolment | 31/12/2013 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
2300 AC
Netherlands
Sponsor information
Hospital/treatment centre
Postbus 121
Leiden
2300 AC
Netherlands
Phone | +31 (0) 71 5730050 |
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jbosch@ravhm.nl | |
Website | http://www.ravhm.nl/ |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not 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.