The Medical Management in Patients Exposed to Weapons of Mass Destruction

Study Overview
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Brief Summary
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Observation study measuring medical response in contaminated environment.

Detailed Description
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This is an ongoing multicentric observational study that aims to assess the medical response to chemical, biological, radiological, nuclear, explosive (cbrne) events during the last five (5) decades (i.e.: 1970-2020), and in any future cbrne attack that might occur within the next 15 years (i.e.: 2021-2036). Of note, the data collection will be performed retrospectively and after sites review ethic board (REB) approval.

Official Title
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Acute Care For Patients Exposed to a Chemical, Biological, Radiological, Nuclear, Explosive: Attack: Protocol For An International Multicentric Observational Study

Conditions
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Chemical Injury, Chemicals; Intoxication, Acute Respiratory Distress Syndrome, Distress Respiratory Syndrome, Medical Emergencies

Intervention / Treatment
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* Procedure: Clinical interventions performed in acute settings (contaminated environment)
* Procedure: Protection (clinician and patient)
* Procedure: Decontamination (clinician and patient)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: i. a CBRNE attack caused at least one casualty who required the assistance of the participating health care system (e.g.: physicians, nurses, paramedics and other health-care specialists of a medical facility) during a medical extraction from the incident site until admission to a medical facility; ii. Patients are eligible if they were exposed to the CBRNE attack; iii. Medical information concerning the CBRNE exposures, even if partial, is accessible to health care professionals for the purposes of filling out the online case report form (eCRF); iv. Participants must be able to complete the online case report form in English; and v. The approval of an Ethics Review Board is obtained by each medical centre participant. Exclusion Criteria: A negative response to any of the inclusion criteria results in an exclusion.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| adult inflicted by a CBRNE weapon<br>Part of the Population is being studied includes any individual who was affected by CBRNE attacks and needed an intervention of the healthcare system. | Procedure: Clinical interventions performed in acute settings (contaminated environment)<br>* Any clinical intervention performed on the patient inflicted by at least one of Chemical, Biological, Radiological, Nuclear, Explosive (CBRNE) weapons in acute settings (from the incident site up to his/her admission to the clean zone of a emergency room or its equivalent (ie.: walking clinic).<br>Procedure: Protection (clinician and patient)<br>* As interrelated competence of the clinical intervention, any protection procedure and capability applied on the patient inflicted by at least one of Chemical, Biological, Radiological, Nuclear, Explosive (CBRNE) weapons in acute settings (from the incident site up to his/her admission to the clean zone of a emergency room or its equivalent (ie.: walking clinic). Concerning the clinician, the protection implied for his/her own safety and for the patient to whom she/he was in closed/contact with.<br>Procedure: Decontamination (clinician and patient)<br>* As interrelated competence of the clinical intervention and protection, any decontamination procedure and capability applied on the patient inflicted by at least one of Chemical, Biological, Radiological, Nuclear, Explosive (CBRNE) weapons in acute settings (from the incident site up to his/her admission to the clean zone of a emergency room or its equivalent (ie.: walking clinic). Concerning the clinician, the protection implied for his/her own safety and for the patient to whom she/he was in closed/contact with. This crucial step is usually expected prior the patient's transfer into a clean zone like the emergency room or its equivalent.<br>|
| Infant inflicted by a CBRNE weapon<br>Part of the population is being studied includes any individual who was affected by CBRNE attacks and needed an intervention of the healthcare system. | Procedure: Clinical interventions performed in acute settings (contaminated environment)<br>* Any clinical intervention performed on the patient inflicted by at least one of Chemical, Biological, Radiological, Nuclear, Explosive (CBRNE) weapons in acute settings (from the incident site up to his/her admission to the clean zone of a emergency room or its equivalent (ie.: walking clinic).<br>Procedure: Protection (clinician and patient)<br>* As interrelated competence of the clinical intervention, any protection procedure and capability applied on the patient inflicted by at least one of Chemical, Biological, Radiological, Nuclear, Explosive (CBRNE) weapons in acute settings (from the incident site up to his/her admission to the clean zone of a emergency room or its equivalent (ie.: walking clinic). Concerning the clinician, the protection implied for his/her own safety and for the patient to whom she/he was in closed/contact with.<br>Procedure: Decontamination (clinician and patient)<br>* As interrelated competence of the clinical intervention and protection, any decontamination procedure and capability applied on the patient inflicted by at least one of Chemical, Biological, Radiological, Nuclear, Explosive (CBRNE) weapons in acute settings (from the incident site up to his/her admission to the clean zone of a emergency room or its equivalent (ie.: walking clinic). Concerning the clinician, the protection implied for his/her own safety and for the patient to whom she/he was in closed/contact with. This crucial step is usually expected prior the patient's transfer into a clean zone like the emergency room or its equivalent.<br>|
| Women inflicted by a CBRNE weapon<br>Part of the Population is being studied includes any individual who was affected by CBRNE attacks and needed an intervention of the healthcare system. | Procedure: Clinical interventions performed in acute settings (contaminated environment)<br>* Any clinical intervention performed on the patient inflicted by at least one of Chemical, Biological, Radiological, Nuclear, Explosive (CBRNE) weapons in acute settings (from the incident site up to his/her admission to the clean zone of a emergency room or its equivalent (ie.: walking clinic).<br>Procedure: Protection (clinician and patient)<br>* As interrelated competence of the clinical intervention, any protection procedure and capability applied on the patient inflicted by at least one of Chemical, Biological, Radiological, Nuclear, Explosive (CBRNE) weapons in acute settings (from the incident site up to his/her admission to the clean zone of a emergency room or its equivalent (ie.: walking clinic). Concerning the clinician, the protection implied for his/her own safety and for the patient to whom she/he was in closed/contact with.<br>Procedure: Decontamination (clinician and patient)<br>* As interrelated competence of the clinical intervention and protection, any decontamination procedure and capability applied on the patient inflicted by at least one of Chemical, Biological, Radiological, Nuclear, Explosive (CBRNE) weapons in acute settings (from the incident site up to his/her admission to the clean zone of a emergency room or its equivalent (ie.: walking clinic). Concerning the clinician, the protection implied for his/her own safety and for the patient to whom she/he was in closed/contact with. This crucial step is usually expected prior the patient's transfer into a clean zone like the emergency room or its equivalent.<br>|
| Men inflicted by a CBRNE weapon<br>Part of the Population is being studied includes any individual who was affected by CBRNE attacks and needed an intervention of the healthcare system. | Procedure: Clinical interventions performed in acute settings (contaminated environment)<br>* Any clinical intervention performed on the patient inflicted by at least one of Chemical, Biological, Radiological, Nuclear, Explosive (CBRNE) weapons in acute settings (from the incident site up to his/her admission to the clean zone of a emergency room or its equivalent (ie.: walking clinic).<br>Procedure: Protection (clinician and patient)<br>* As interrelated competence of the clinical intervention, any protection procedure and capability applied on the patient inflicted by at least one of Chemical, Biological, Radiological, Nuclear, Explosive (CBRNE) weapons in acute settings (from the incident site up to his/her admission to the clean zone of a emergency room or its equivalent (ie.: walking clinic). Concerning the clinician, the protection implied for his/her own safety and for the patient to whom she/he was in closed/contact with.<br>Procedure: Decontamination (clinician and patient)<br>* As interrelated competence of the clinical intervention and protection, any decontamination procedure and capability applied on the patient inflicted by at least one of Chemical, Biological, Radiological, Nuclear, Explosive (CBRNE) weapons in acute settings (from the incident site up to his/her admission to the clean zone of a emergency room or its equivalent (ie.: walking clinic). Concerning the clinician, the protection implied for his/her own safety and for the patient to whom she/he was in closed/contact with. This crucial step is usually expected prior the patient's transfer into a clean zone like the emergency room or its equivalent.<br>|
| Elderly inflicted by a CBRNE weapon<br>Part of the Population is being studied includes any individual who was affected by CBRNE attacks and needed an intervention of the healthcare system. | Procedure: Clinical interventions performed in acute settings (contaminated environment)<br>* Any clinical intervention performed on the patient inflicted by at least one of Chemical, Biological, Radiological, Nuclear, Explosive (CBRNE) weapons in acute settings (from the incident site up to his/her admission to the clean zone of a emergency room or its equivalent (ie.: walking clinic).<br>Procedure: Protection (clinician and patient)<br>* As interrelated competence of the clinical intervention, any protection procedure and capability applied on the patient inflicted by at least one of Chemical, Biological, Radiological, Nuclear, Explosive (CBRNE) weapons in acute settings (from the incident site up to his/her admission to the clean zone of a emergency room or its equivalent (ie.: walking clinic). Concerning the clinician, the protection implied for his/her own safety and for the patient to whom she/he was in closed/contact with.<br>Procedure: Decontamination (clinician and patient)<br>* As interrelated competence of the clinical intervention and protection, any decontamination procedure and capability applied on the patient inflicted by at least one of Chemical, Biological, Radiological, Nuclear, Explosive (CBRNE) weapons in acute settings (from the incident site up to his/her admission to the clean zone of a emergency room or its equivalent (ie.: walking clinic). Concerning the clinician, the protection implied for his/her own safety and for the patient to whom she/he was in closed/contact with. This crucial step is usually expected prior the patient's transfer into a clean zone like the emergency room or its equivalent.<br>|
| Diagnosed with chronic disease(s) inflicted by a CBRNE weapon<br>Part of the Population is being studied includes any individual who was affected by CBRNE attacks and needed an intervention of the healthcare system. | Procedure: Clinical interventions performed in acute settings (contaminated environment)<br>* Any clinical intervention performed on the patient inflicted by at least one of Chemical, Biological, Radiological, Nuclear, Explosive (CBRNE) weapons in acute settings (from the incident site up to his/her admission to the clean zone of a emergency room or its equivalent (ie.: walking clinic).<br>Procedure: Protection (clinician and patient)<br>* As interrelated competence of the clinical intervention, any protection procedure and capability applied on the patient inflicted by at least one of Chemical, Biological, Radiological, Nuclear, Explosive (CBRNE) weapons in acute settings (from the incident site up to his/her admission to the clean zone of a emergency room or its equivalent (ie.: walking clinic). Concerning the clinician, the protection implied for his/her own safety and for the patient to whom she/he was in closed/contact with.<br>Procedure: Decontamination (clinician and patient)<br>* As interrelated competence of the clinical intervention and protection, any decontamination procedure and capability applied on the patient inflicted by at least one of Chemical, Biological, Radiological, Nuclear, Explosive (CBRNE) weapons in acute settings (from the incident site up to his/her admission to the clean zone of a emergency room or its equivalent (ie.: walking clinic). Concerning the clinician, the protection implied for his/her own safety and for the patient to whom she/he was in closed/contact with. This crucial step is usually expected prior the patient's transfer into a clean zone like the emergency room or its equivalent.<br>|
| Clinician (adult) whom performs his/her clinical interventions<br>Clinician (adult) whom performs his/her clinical interventions while integrating competences in protections and decontamination. Part of the Population is being studied includes any individual who was affected by CBRNE attacks and needed an intervention of the healthcare system. This is the case of when the clinician is required to ensure safety toward his/her patient while performing his/her interventions & procedures. | Procedure: Clinical interventions performed in acute settings (contaminated environment)<br>* Any clinical intervention performed on the patient inflicted by at least one of Chemical, Biological, Radiological, Nuclear, Explosive (CBRNE) weapons in acute settings (from the incident site up to his/her admission to the clean zone of a emergency room or its equivalent (ie.: walking clinic).<br>Procedure: Protection (clinician and patient)<br>* As interrelated competence of the clinical intervention, any protection procedure and capability applied on the patient inflicted by at least one of Chemical, Biological, Radiological, Nuclear, Explosive (CBRNE) weapons in acute settings (from the incident site up to his/her admission to the clean zone of a emergency room or its equivalent (ie.: walking clinic). Concerning the clinician, the protection implied for his/her own safety and for the patient to whom she/he was in closed/contact with.<br>Procedure: Decontamination (clinician and patient)<br>* As interrelated competence of the clinical intervention and protection, any decontamination procedure and capability applied on the patient inflicted by at least one of Chemical, Biological, Radiological, Nuclear, Explosive (CBRNE) weapons in acute settings (from the incident site up to his/her admission to the clean zone of a emergency room or its equivalent (ie.: walking clinic). Concerning the clinician, the protection implied for his/her own safety and for the patient to whom she/he was in closed/contact with. This crucial step is usually expected prior the patient's transfer into a clean zone like the emergency room or its equivalent.<br>|
| Clinician (adult) injured by duties circumstances<br>Part of the Population is being studied includes any individual who was affected by CBRNE attacks and needed an intervention of the healthcare system. This is the case of when the clinician becomes inflicted by a CBRNE weapon while intervening toward contaminated patient due to any failure in protection and decontamination. | Procedure: Clinical interventions performed in acute settings (contaminated environment)<br>* Any clinical intervention performed on the patient inflicted by at least one of Chemical, Biological, Radiological, Nuclear, Explosive (CBRNE) weapons in acute settings (from the incident site up to his/her admission to the clean zone of a emergency room or its equivalent (ie.: walking clinic).<br>Procedure: Protection (clinician and patient)<br>* As interrelated competence of the clinical intervention, any protection procedure and capability applied on the patient inflicted by at least one of Chemical, Biological, Radiological, Nuclear, Explosive (CBRNE) weapons in acute settings (from the incident site up to his/her admission to the clean zone of a emergency room or its equivalent (ie.: walking clinic). Concerning the clinician, the protection implied for his/her own safety and for the patient to whom she/he was in closed/contact with.<br>Procedure: Decontamination (clinician and patient)<br>* As interrelated competence of the clinical intervention and protection, any decontamination procedure and capability applied on the patient inflicted by at least one of Chemical, Biological, Radiological, Nuclear, Explosive (CBRNE) weapons in acute settings (from the incident site up to his/her admission to the clean zone of a emergency room or its equivalent (ie.: walking clinic). Concerning the clinician, the protection implied for his/her own safety and for the patient to whom she/he was in closed/contact with. This crucial step is usually expected prior the patient's transfer into a clean zone like the emergency room or its equivalent.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intervention and location | The percentage of patients to whom the World Health Organization's healthcare guidelines were applied without any delay (i.e.: during a medical extraction/evacuation) | At the patient's admission at the hospital emergency room (i.e.: end-point of the medical extraction/evacuation). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contamination is under-control due to efficient protective measures applied during a medical extraction/evacuation | The percentage of patients whose health condition remained stable during a medical extraction due to efficient WHO's protective measures applied | At the patient's admission at the hospital emergency room (i.e.: end-point of the medical extraction/evacuation). | 
| Contamination under-control due to efficient decontamination measures applied during a medical extraction/evacuation | The percentage of patients whose health condition remained stable during a medical extraction due to efficient WHO's decontamination measures applied | At the patient's admission at the hospital emergency room (i.e.: end-point of the medical extraction/evacuation). | 
| Deterioration of the patient's health condition due to compromised means of protection | The percentage of patients whose health condition deteriorate during a medical extraction due to the misuse of WHO's protective measures (e.g.: mask, suit, gloves, boots, etc). | At the patient's admission at the hospital emergency room (i.e.: end-point of the medical extraction/evacuation). | 
| Deterioration of the patient's health condition due to compromised means of decontamination | The percentage of patients whose health condition deteriorated during a medical extraction due to the misuse of WHO's decontamination measures (e.g.: immediate (roughly) or/and thorough (specialized one)). | At the patient's admission at the hospital emergency room (i.e.: end-point of the medical extraction/evacuation). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CBRNE Defence, Acute Settings, Pre-Hospital Settings, Decontamination, Protection, Respiratory Insults, Treatments