The Medical Management in Patients Exposed to Weapons of Mass Destruction

• Conditions: Acute Respiratory Distress Syndrome; Distress Respiratory Syndrome; Chemical Injury; Medical Emergencies; Chemicals; Intoxication
• Interventions: Procedure: Clinical interventions performed in acute settings (contaminated environment); Procedure: Protection (clinician and patient); Procedure: Decontamination (clinician and patient)

• Registration Number: NCT05026645
• Lead Sponsor: St. Justine's Hospital

Brief Summary

Observation study measuring medical response in contaminated environment.

Detailed Description

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.

Study Timeline

• Study Start: 2020-10-01
• Study First Submitted: 2021-08-18
• Study First Submitted QC: 2021-08-23
• Study First Posted: 2021-08-30
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-26
• Last Update Posted: 2024-11-28
• Primary Completion: 2036-11-01
• Study Completion: 2036-12-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Infant inflicted by a CBRNE weapon	Protection (clinician and patient)	Part of the population is being studied includes any individual who was affected by CBRNE attacks and needed an intervention of the healthcare system.
Women inflicted by a CBRNE weapon	Clinical interventions performed in acute settings (contaminated environment)	Part of the Population is being studied includes any individual who was affected by CBRNE attacks and needed an intervention of the healthcare system.
Infant inflicted by a CBRNE weapon	Clinical interventions performed in acute settings (contaminated environment)	Part of the population is being studied includes any individual who was affected by CBRNE attacks and needed an intervention of the healthcare system.
Men inflicted by a CBRNE weapon	Protection (clinician and patient)	Part of the Population is being studied includes any individual who was affected by CBRNE attacks and needed an intervention of the healthcare system.
Elderly inflicted by a CBRNE weapon	Clinical interventions performed in acute settings (contaminated environment)	Part of the Population is being studied includes any individual who was affected by CBRNE attacks and needed an intervention of the healthcare system.
adult inflicted by a CBRNE weapon	Clinical interventions performed in acute settings (contaminated environment)	Part of the Population is being studied includes any individual who was affected by CBRNE attacks and needed an intervention of the healthcare system.
adult inflicted by a CBRNE weapon	Decontamination (clinician and patient)	Part of the Population is being studied includes any individual who was affected by CBRNE attacks and needed an intervention of the healthcare system.
adult inflicted by a CBRNE weapon	Protection (clinician and patient)	Part of the Population is being studied includes any individual who was affected by CBRNE attacks and needed an intervention of the healthcare system.
Infant inflicted by a CBRNE weapon	Decontamination (clinician and patient)	Part of the population is being studied includes any individual who was affected by CBRNE attacks and needed an intervention of the healthcare system.
Elderly inflicted by a CBRNE weapon	Protection (clinician and patient)	Part of the Population is being studied includes any individual who was affected by CBRNE attacks and needed an intervention of the healthcare system.
Elderly inflicted by a CBRNE weapon	Decontamination (clinician and patient)	Part of the Population is being studied includes any individual who was affected by CBRNE attacks and needed an intervention of the healthcare system.
Diagnosed with chronic disease(s) inflicted by a CBRNE weapon	Protection (clinician and patient)	Part of the Population is being studied includes any individual who was affected by CBRNE attacks and needed an intervention of the healthcare system.
Women inflicted by a CBRNE weapon	Protection (clinician and patient)	Part of the Population is being studied includes any individual who was affected by CBRNE attacks and needed an intervention of the healthcare system.
Men inflicted by a CBRNE weapon	Clinical interventions performed in acute settings (contaminated environment)	Part of the Population is being studied includes any individual who was affected by CBRNE attacks and needed an intervention of the healthcare system.
Men inflicted by a CBRNE weapon	Decontamination (clinician and patient)	Part of the Population is being studied includes any individual who was affected by CBRNE attacks and needed an intervention of the healthcare system.
Diagnosed with chronic disease(s) inflicted by a CBRNE weapon	Clinical interventions performed in acute settings (contaminated environment)	Part of the Population is being studied includes any individual who was affected by CBRNE attacks and needed an intervention of the healthcare system.
Diagnosed with chronic disease(s) inflicted by a CBRNE weapon	Decontamination (clinician and patient)	Part of the Population is being studied includes any individual who was affected by CBRNE attacks and needed an intervention of the healthcare system.
Clinician (adult) injured by duties circumstances	Protection (clinician and patient)	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.
Women inflicted by a CBRNE weapon	Decontamination (clinician and patient)	Part of the Population is being studied includes any individual who was affected by CBRNE attacks and needed an intervention of the healthcare system.
Clinician (adult) whom performs his/her clinical interventions	Protection (clinician and patient)	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.
Clinician (adult) whom performs his/her clinical interventions	Decontamination (clinician and patient)	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.
Clinician (adult) injured by duties circumstances	Clinical interventions performed in acute settings (contaminated environment)	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.
Clinician (adult) injured by duties circumstances	Decontamination (clinician and patient)	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.
Clinician (adult) whom performs his/her clinical interventions	Clinical interventions performed in acute settings (contaminated environment)	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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
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)).
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).

Trial Locations

Locations (12)

Director, Unconventional Weapons & Technology Division, National Consortium for the Study of Terrorism and Responses to Terrorism University of Maryland; 🇺🇸 College Park, Maryland, United States

Centre for Defence and Security Studies, University of Manitoba; 🇨🇦 Winnipeg, Manitoba, Canada

School of Nursing, Manitoba University; 🇨🇦 Winnipeg, Manitoba, Canada

Royal Canadian Medical Corps; 🇨🇦 Ottawa, Ontario, Canada

Research Center of the CHU St-Justine, University of Montreal; 🇨🇦 Montreal, Quebec, Canada

Biomedical Telematics Laboratory Platform of the Quebec Respiratory Health Research Network; 🇨🇦 Sherbrooke, Quebec, Canada

Research Centre, Quebec Heart and Lung Institute, Laval University; 🇨🇦 Quebec, Canada

Medical Intelligence CBRNE Inc.; 🇨🇦 Quebec, Canada

Sorbonne University; 🇫🇷 Paris, ile de France, France

Tokyo Women's Medical University, Department of Intensive Care Medicine; 🇯🇵 Tokyo, Shinjuku-ku, Japan

Department of Critical care, Miyagi Children's Hospital; 🇯🇵 Tokyo, Japan

Department of Disaster Medical Management, The University of Tokyo Hospital; 🇯🇵 Tokyo, Japan