- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05026645
The Medical Management in Patients Exposed to Weapons of Mass Destruction (CBRNEObs)
Acute Care For Patients Exposed to a Chemical, Biological, Radiological, Nuclear, Explosive: Attack: Protocol For An International Multicentric Observational Study
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
Manitoba
-
Winnipeg, Manitoba, Canada, R3T 2N2
- Centre for Defence and Security Studies, University of Manitoba
-
-
Ontario
-
Ottawa, Ontario, Canada, K1A0K2
- Royal Canadian Medical Corps
-
-
Quebec
-
Montreal, Quebec, Canada, H3T 1C5
- Research Center of the CHU St-Justine, University of Montreal
-
Montreal, Quebec, Canada, H3C 1K3
- École de Technologie Supérieure Université du Québec
-
Québec, Quebec, Canada, G1V0C8
- Medical Intelligence CBRNE Inc.
-
Québec, Quebec, Canada, G1V 4G5
- Research Centre, Quebec Heart and Lung Institute, Laval University
-
Sherbrooke, Quebec, Canada, J1K 2R1
- Biomedical Telematics Laboratory Platform of the Quebec Respiratory Health Research Network
-
-
-
-
Prague
-
Prague, Prague, Czechia, 10100
- University of Finance and Administration Department of Criminology and Forensic Disciplines
-
-
-
-
Île-de-France Region
-
Paris, Île-de-France Region, France
- Sorbonne University
-
-
-
-
-
Tokyo, Japan
- Department of Critical care, Miyagi Children's Hospital
-
Tokyo, Japan
- Department of Disaster Medical Management, The University of Tokyo Hospital
-
-
Shinjuku-ku
-
Tokyo, Shinjuku-ku, Japan
- Tokyo Women's Medical University, Department of Intensive Care Medicine
-
-
-
-
-
Winchester, United Kingdom, SO23 8UT
- CBRNE World Journal
-
-
Redhill
-
Surrey Quays, Redhill, United Kingdom, RH1 5RH
- Surrey and Sussex Healthcare NHS Trust
-
-
-
-
Maryland
-
College Park, Maryland, United States, 20740
- Director, Unconventional Weapons & Technology Division, National Consortium for the Study of Terrorism and Responses to Terrorism University of Maryland
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
adult inflicted by a CBRNE weapon
Part of the Population is being studied includes any individual who was affected by CBRNE attacks and needed an intervention of the healthcare system.
|
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).
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.
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.
|
|
Infant inflicted by a CBRNE weapon
Part of the population is being studied includes any individual who was affected by CBRNE attacks and needed an intervention of the healthcare system.
|
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).
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.
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.
|
|
Women inflicted by a CBRNE weapon
Part of the Population is being studied includes any individual who was affected by CBRNE attacks and needed an intervention of the healthcare system.
|
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).
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.
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.
|
|
Men inflicted by a CBRNE weapon
Part of the Population is being studied includes any individual who was affected by CBRNE attacks and needed an intervention of the healthcare system.
|
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).
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.
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.
|
|
Elderly inflicted by a CBRNE weapon
Part of the Population is being studied includes any individual who was affected by CBRNE attacks and needed an intervention of the healthcare system.
|
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).
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.
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.
|
|
Diagnosed with chronic disease(s) inflicted by a CBRNE weapon
Part of the Population is being studied includes any individual who was affected by CBRNE attacks and needed an intervention of the healthcare system.
|
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).
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.
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.
|
|
Clinician (adult) whom performs his/her clinical interventions
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.
|
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).
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.
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.
|
|
Clinician (adult) injured by duties circumstances
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.
|
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).
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intervention and location
Time Frame: At the patient's admission at the hospital emergency room (i.e.: end-point of the medical extraction/evacuation).
|
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
Time Frame: At the patient's admission at the hospital emergency room (i.e.: end-point of the 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
Time Frame: At the patient's admission at the hospital emergency room (i.e.: end-point of the 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
Time Frame: At the patient's admission at the hospital emergency room (i.e.: end-point of the medical extraction/evacuation).
|
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
Time Frame: At the patient's admission at the hospital emergency room (i.e.: end-point of the medical extraction/evacuation).
|
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).
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Stephane Bourassa, Ste-Justine's Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-2561
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Acute Respiratory Distress Syndrome
-
Shanghai University of Traditional Chinese MedicineRecruitingAcute Respiratory Distress Syndrome (ARDS) | Acute Lung Injury(ALI) | Sepsis Related Acute Lung Injury/Acute Respiratory Distress SyndromeChina
-
PT. Prodia Stem Cell IndonesiaRumah Sakit Pusat Angkatan Darat Gatot SoebrotoRecruitingAcute Respiratory Distress SyndromeIndonesia
-
Fondazione IRCCS Ca' Granda, Ospedale Maggiore...Not yet recruiting
-
Changchun Tuohua Pharmaceutical Co., Ltd.RecruitingAcute Respiratory Distress SyndromeChina
-
Southeast University, ChinaRecruitingAcute Respiratory Distress SyndromeChina
-
Southeast University, ChinaRecruitingAcute Respiratory Distress SyndromeChina
-
Oslo University HospitalRigshospitalet, Denmark; Aalborg University HospitalNot yet recruitingAcute Respiratory Distress Syndrome (ARDS) | Acute Hypoxemic Respiratory Failure
-
HTIC, IncRecruitingARDS (Acute Respiratory Distress Syndrome)United States
-
Fayoum UniversityNot yet recruitingAcute Respiratory Distress Syndrome (ARDS)
-
Assistance Publique - Hôpitaux de ParisNot yet recruitingAcute Respiratory Distress Syndrome (ARDS)