CBRNE Obs: The Medical Management in Patients Exposed to Chemical Weapons.

Sponsor

St. Justine's Hospital (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05026645

Collaborator

Dr Philippe Jouvet, MD, PhD; Sainte-Justine University Hospital Research Center, Montreal, Canada (Other), Dr Jacinthe Leclerc, RN, PhD; University of Quebec at Trois-Rivières, Trois-Rivières,Canada (Other), Dr Jérôme Rambaud, MD, PhD; Sorbonne University, Paris, France (Other), Major (retired) Daniel Noebert, Medical Intelligence CBRNE inc.; Quebec City, Canada (Other), Nadine Laflamme, Medical Intelligence CBRNE inc.; Quebec City, Canada (Other), Dr Marc Dauphin, MD, Medical Intelligence CBRNE inc.; Quebec City, Canada (Other), MWO (retired) François Leger, CD, Medical Intelligence CBRNE inc.; Quebec City, Canada (Other), Dr Atsushi Kawaguchi, MD,PhD; Department of Intensive Care Medicine, Tokyo, Japan (Other), Hristijan Ivanovski; University of Manitoba Centre for Defence and Security Studies (Other), Dr Guillaume Jean, MD; Université Laval CRIUCPQ, Quebec City, Canada (Other), Major (Retired) Daan Beijer, CD; Medical Intelligence CBRNE inc.; Quebec City, Canada (Other), Lieutenant (Navy) Jeffrey Lee, RN, CD; Affiliation: Department of National Defence, Ottawa, Canada (Other)

1,000

Enrollment

Locations

180

Anticipated Duration (Months)

142.9

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Observation study measuring medical response in contaminated environment.

Condition or Disease	Intervention/Treatment	Phase
Chemical Injury Chemicals; Intoxication Acute Respiratory Distress Syndrome Distress Respiratory Syndrome Medical Emergencies	Procedure: Clinical interventions performed in acute settings (contaminated environment) Procedure: Protection (clinician and patient) Procedure: Decontamination (clinician and patient)

Detailed Description

This is an ongoing multicentric observational study that aims to assess the medical response to chemical events during the last five (5) decades (i.e.: 1970-2020), and in any future chemical 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Other

Time Perspective:

Retrospective

Official Title:

Patient Management in the Contaminated Zone After Exposure to a Chemical Attack: an Multi-Centric Observational Study.

Actual Study Start Date :

Oct 1, 2020

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Oct 1, 2035

Arms and Interventions

Arm	Intervention/Treatment
adult inflicted by a chemical weapon Part of the Population is being studied includes any individual who was affected by chemical attacks and was needed an intervention of the healthcare system.	Procedure: Clinical interventions performed in acute settings (contaminated environment) Any clinical intervention performed on the patient inflicted by the chemical weapon 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). Procedure: Protection (clinician and patient) As interrelated competence of the clinical intervention, any protection procedure and capability applied on the patient inflicted by the chemical weapon 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. Procedure: Decontamination (clinician and patient) As interrelated competence of the clinical intervention and protection, any decontamination procedure and capability applied on the patient inflicted by the chemical weapon 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 chemical weapon Part of the Population is being studied includes any individual who was affected by chemical attacks and was needed an intervention of the healthcare system.	Procedure: Clinical interventions performed in acute settings (contaminated environment) Any clinical intervention performed on the patient inflicted by the chemical weapon 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). Procedure: Protection (clinician and patient) As interrelated competence of the clinical intervention, any protection procedure and capability applied on the patient inflicted by the chemical weapon 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. Procedure: Decontamination (clinician and patient) As interrelated competence of the clinical intervention and protection, any decontamination procedure and capability applied on the patient inflicted by the chemical weapon 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 chemical weapon Part of the Population is being studied includes any individual who was affected by chemical attacks and was needed an intervention of the healthcare system.	Procedure: Clinical interventions performed in acute settings (contaminated environment) Any clinical intervention performed on the patient inflicted by the chemical weapon 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). Procedure: Protection (clinician and patient) As interrelated competence of the clinical intervention, any protection procedure and capability applied on the patient inflicted by the chemical weapon 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. Procedure: Decontamination (clinician and patient) As interrelated competence of the clinical intervention and protection, any decontamination procedure and capability applied on the patient inflicted by the chemical weapon 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 chemical weapon Part of the Population is being studied includes any individual who was affected by chemical attacks and was needed an intervention of the healthcare system.	Procedure: Clinical interventions performed in acute settings (contaminated environment) Any clinical intervention performed on the patient inflicted by the chemical weapon 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). Procedure: Protection (clinician and patient) As interrelated competence of the clinical intervention, any protection procedure and capability applied on the patient inflicted by the chemical weapon 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. Procedure: Decontamination (clinician and patient) As interrelated competence of the clinical intervention and protection, any decontamination procedure and capability applied on the patient inflicted by the chemical weapon 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 chemical weapon Part of the Population is being studied includes any individual who was affected by chemical attacks and was needed an intervention of the healthcare system.	Procedure: Clinical interventions performed in acute settings (contaminated environment) Any clinical intervention performed on the patient inflicted by the chemical weapon 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). Procedure: Protection (clinician and patient) As interrelated competence of the clinical intervention, any protection procedure and capability applied on the patient inflicted by the chemical weapon 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. Procedure: Decontamination (clinician and patient) As interrelated competence of the clinical intervention and protection, any decontamination procedure and capability applied on the patient inflicted by the chemical weapon 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 chemical weapon Part of the Population is being studied includes any individual who was affected by chemical attacks and was needed an intervention of the healthcare system.	Procedure: Clinical interventions performed in acute settings (contaminated environment) Any clinical intervention performed on the patient inflicted by the chemical weapon 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). Procedure: Protection (clinician and patient) As interrelated competence of the clinical intervention, any protection procedure and capability applied on the patient inflicted by the chemical weapon 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. Procedure: Decontamination (clinician and patient) As interrelated competence of the clinical intervention and protection, any decontamination procedure and capability applied on the patient inflicted by the chemical weapon 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 chemical attacks and was 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) Any clinical intervention performed on the patient inflicted by the chemical weapon 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). Procedure: Protection (clinician and patient) As interrelated competence of the clinical intervention, any protection procedure and capability applied on the patient inflicted by the chemical weapon 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. Procedure: Decontamination (clinician and patient) As interrelated competence of the clinical intervention and protection, any decontamination procedure and capability applied on the patient inflicted by the chemical weapon 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 chemical attacks and was needed an intervention of the healthcare system. This is the case of when the clinician becomes inflicted by the chemical while intervening toward contaminated patient due to any failure in protection and decontamination.	Procedure: Clinical interventions performed in acute settings (contaminated environment) Any clinical intervention performed on the patient inflicted by the chemical weapon 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). Procedure: Protection (clinician and patient) As interrelated competence of the clinical intervention, any protection procedure and capability applied on the patient inflicted by the chemical weapon 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. Procedure: Decontamination (clinician and patient) As interrelated competence of the clinical intervention and protection, any decontamination procedure and capability applied on the patient inflicted by the chemical weapon 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.

Outcome Measures

Primary Outcome Measures

Intervention and location [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)

Secondary Outcome Measures

Contamination is under-control due to efficient protective measures applied during a medical extraction/evacuation [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
Contamination under-control due to efficient decontamination measures applied during a medical extraction/evacuation [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
Deterioration of the patient's health condition due to compromised means of protection [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).
Deterioration of the patient's health condition due to compromised means of decontamination [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)).

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

The chemical attack occurred between 1970 and 2035 for which a confirmation was made by reliable authorities (e.g.: US Intelligence community);
The chemical attack was part of a conventional military operation, mass attack, political assassination or terrorist event;
The chemical attack cause at least one casualty who required the assistance of the health care professionals (e.g.: physicians, nurses, paramedics and other health care specialists) during a medical extraction from the incident site up-to an admission into a medical facility;
Medical information concerning the chemical exposures is accessible to health care professional for filling out the electronic case report form (eCRF);
The completion of the eCRF is only in English language; and
An Ethical Review Board approval is obtained by each medical center participant

Exclusion Criteria:

• Despite the are no exclusion defined criteria, a negative response to one of the inclusion criteria results to an exclusion.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Manitoba Centre for Defence and Security Studies	Winnipeg	Manitoba	Canada	R3T 2N2
2	Royal Canadian Medical Corps	Ottawa	Ontario	Canada	K1A0K2
3	Research Center of the CHU St-Justine	Montreal	Quebec	Canada	H3T 1C5
4	University Institute of Cardiology and Respirology of Quebec	Quebec		Canada	G1V 4G5
5	Medical Intelligence CBRNE Inc.	Quebec		Canada	G1V0C8
6	Sorbonne University	Paris	Ile De France	France
7	Tokyo Women's Medical University, Department of Intensive Care Medicine	Tokyo	Shinjuku-ku	Japan

Sponsors and Collaborators

St. Justine's Hospital
Dr Philippe Jouvet, MD, PhD; Sainte-Justine University Hospital Research Center, Montreal, Canada
Dr Jacinthe Leclerc, RN, PhD; University of Quebec at Trois-Rivières, Trois-Rivières,Canada
Dr Jérôme Rambaud, MD, PhD; Sorbonne University, Paris, France
Major (retired) Daniel Noebert, Medical Intelligence CBRNE inc.; Quebec City, Canada
Nadine Laflamme, Medical Intelligence CBRNE inc.; Quebec City, Canada
Dr Marc Dauphin, MD, Medical Intelligence CBRNE inc.; Quebec City, Canada
MWO (retired) François Leger, CD, Medical Intelligence CBRNE inc.; Quebec City, Canada
Dr Atsushi Kawaguchi, MD,PhD; Department of Intensive Care Medicine, Tokyo, Japan
Hristijan Ivanovski; University of Manitoba Centre for Defence and Security Studies
Dr Guillaume Jean, MD; Université Laval CRIUCPQ, Quebec City, Canada
Major (Retired) Daan Beijer, CD; Medical Intelligence CBRNE inc.; Quebec City, Canada
Lieutenant (Navy) Jeffrey Lee, RN, CD; Affiliation: Department of National Defence, Ottawa, Canada