Resuscitation Hollands-Midden (RHM) study

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 design	Prospective single-center observational study
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
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

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 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.