The Medical Management in Patients Exposed to Weapons of Mass Destruction. (CBRNE Obs)

• ClinicalTrials.gov Identifier: NCT05026645
• Recruitment Status: Enrolling by invitation
• First Posted: August 30, 2021
• Last Update Posted: March 17, 2023
• Sponsor: St. Justine's Hospital
• Collaborators: Dr Philippe Jouvet, MD, PhD; Sainte-Justine University Hospital Research Center, Montreal, Canada; Dr Jacinthe Leclerc, RN, PhD; Research Centre, Quebec Heart and Lung Institute & Laval University, Quebec City, Quebec, Canada; Dr Jérôme Rambaud, MD, PhD; Sorbonne University, Paris, France; Major (retired) Daniel Noebert, Medical Intelligence CBRNE inc.; Quebec City, Quebec, Canada; Nadine Laflamme, Medical Intelligence CBRNE inc.; Quebec City, Quebec, Canada; Dr (retired) Marc Dauphin, MD, Medical Intelligence CBRNE inc.; Quebec City, Quebec, Canada; MWO (retired) François Leger, CD, Medical Intelligence CBRNE inc.; Quebec City, Quebec, Canada; Dr Atsushi Kawaguchi, MD,PhD; Department of Intensive Care Medicine, Tokyo, Japan; Hristijan Ivanovski, MA; Faculty of Arts, Centre for Defence and Security Studies, University of Manitoba, Winnipeg, Manitoba, Canada; Dr Guillaume Jean, MD; Université Laval Quebec Heart and Lung Institute - Laval University, Quebec City, Quebec, Canada; Major (Retired) Daan Beijer, CD; Medical Intelligence CBRNE inc.; Quebec City, Canada; Lieutenant (Navy) Jeffrey Lee, RN, CD; Affiliated with Department of National Defence, Ottawa, Canada; M. Serge Simard, Research Centre, Quebec Heart and Lung Institute - Laval University, Quebec City, Quebec, Canada; Dr Mariem Abid, Ing, PhD; Applicare AI, Montreal, Quebec, Canada; M. Pelumi Samuel Akinola, MSc(c), RN; University of Manitoba, Winnipeg, Manitoba, Canada; M. Yvan Fortier; Biomedical Telematics Laboratory Platform of the Quebec Respiratory Health Research Network, Sherbrooke, Quebec, Canada; M. Mina Dligui; Biomedical Telematics Laboratory Platform of the Quebec Respiratory Health Research Network, Sherbrooke, Quebec, Canada; Mrs Hiroko Yuzawa, MD, PhD(c); Department of Intensive Care Medicine, Tokyo, Japan; Mr Takehiro Tanabe, MD, PhD(c); Department of Intensive Care Medicine, Tokyo, Japan
• Information provided by (Responsible Party): Stephane Bourassa, St. Justine's Hospital

Study Description

Brief Summary:

Observation study measuring medical response in contaminated environment.

Condition or disease	Intervention/treatment
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, 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 Design

• Study Type: Observational
• Estimated Enrollment: 1000 participants
• Observational Model: Other
• Time Perspective: Retrospective
• Official Title: ACUTE CARE FOR PATIENTS EXPOSED TO A CHEMICAL, BIOLOGICAL, RADIOLOGICAL, NUCLEAR, EXPLOSIVE: ATTACK: PROTOCOL FOR AN INTERNATIONAL MULTICENTRIC OBSERVATIONAL STUDY
• Actual Study Start Date: October 1, 2020
• Estimated Primary Completion Date: October 1, 2023
• Estimated Study Completion Date: October 1, 2035

Groups and Cohorts

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.	Procedure: Clinical interventions performed in acute settings (contaminated environment); 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).; Procedure: Protection (clinician and patient); 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.; 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 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.	Procedure: Clinical interventions performed in acute settings (contaminated environment); 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).; Procedure: Protection (clinician and patient); 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.; 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 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.	Procedure: Clinical interventions performed in acute settings (contaminated environment); 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).; Procedure: Protection (clinician and patient); 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.; 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 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.	Procedure: Clinical interventions performed in acute settings (contaminated environment); 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).; Procedure: Protection (clinician and patient); 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.; 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 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.	Procedure: Clinical interventions performed in acute settings (contaminated environment); 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).; Procedure: Protection (clinician and patient); 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.; 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 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.	Procedure: Clinical interventions performed in acute settings (contaminated environment); 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).; Procedure: Protection (clinician and patient); 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.; 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 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.	Procedure: Clinical interventions performed in acute settings (contaminated environment); 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).; Procedure: Protection (clinician and patient); 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.; 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 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.	Procedure: Clinical interventions performed in acute settings (contaminated environment); 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).; Procedure: Protection (clinician and patient); 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.; 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 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.

Outcome Measures

Primary Outcome Measures :

1. 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)

Secondary Outcome Measures :

1. 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
2. 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
3. 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).
4. 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)).

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Population is being studied includes any individual who was affected by CBRNE attacks and needed an intervention of the healthcare system.

Criteria

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.

Contacts and Locations

Locations

Canada, Manitoba

Centre for Defence and Security Studies, University of Manitoba

Winnipeg, Manitoba, Canada, R3T 2N2

School of Nursing, Manitoba University

Winnipeg, Manitoba, Canada, R3T 2N2

Canada, Ontario

Royal Canadian Medical Corps

Ottawa, Ontario, Canada, K1A0K2

Canada, Quebec

Research Center of the CHU St-Justine, University of Montreal

Montreal, Quebec, Canada, H3T 1C5

Applicare IA

Montreal, Quebec, Canada, H7L4W3

Biomedical Telematics Laboratory Platform of the Quebec Respiratory Health Research Network

Sherbrooke, Quebec, Canada, J1K 2R1

Canada

Research Centre, Quebec Heart and Lung Institute, Laval University

Quebec, Canada, G1V 4G5

Medical Intelligence CBRNE Inc.

Quebec, Canada, G1V0C8

France

Sorbonne University

Paris, Ile De France, France

Japan

Tokyo Women's Medical University, Department of Intensive Care Medicine

Tokyo, Shinjuku-ku, Japan

Department of Intensive Care Medicine, Tokyo, Japan

Tokyo, Japan

Intensive Care Department, Faculty of Medicine

Tokyo, 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; Research Centre, Quebec Heart and Lung Institute & Laval University, Quebec City, Quebec, Canada

Dr Jérôme Rambaud, MD, PhD; Sorbonne University, Paris, France

Major (retired) Daniel Noebert, Medical Intelligence CBRNE inc.; Quebec City, Quebec, Canada

Nadine Laflamme, Medical Intelligence CBRNE inc.; Quebec City, Quebec, Canada

Dr (retired) Marc Dauphin, MD, Medical Intelligence CBRNE inc.; Quebec City, Quebec, Canada

MWO (retired) François Leger, CD, Medical Intelligence CBRNE inc.; Quebec City, Quebec, Canada

Dr Atsushi Kawaguchi, MD,PhD; Department of Intensive Care Medicine, Tokyo, Japan

Hristijan Ivanovski, MA; Faculty of Arts, Centre for Defence and Security Studies, University of Manitoba, Winnipeg, Manitoba, Canada

Dr Guillaume Jean, MD; Université Laval Quebec Heart and Lung Institute - Laval University, Quebec City, Quebec, Canada

Major (Retired) Daan Beijer, CD; Medical Intelligence CBRNE inc.; Quebec City, Canada

Lieutenant (Navy) Jeffrey Lee, RN, CD; Affiliated with Department of National Defence, Ottawa, Canada

M. Serge Simard, Research Centre, Quebec Heart and Lung Institute - Laval University, Quebec City, Quebec, Canada

Dr Mariem Abid, Ing, PhD; Applicare AI, Montreal, Quebec, Canada

M. Pelumi Samuel Akinola, MSc(c), RN; University of Manitoba, Winnipeg, Manitoba, Canada

M. Yvan Fortier; Biomedical Telematics Laboratory Platform of the Quebec Respiratory Health Research Network, Sherbrooke, Quebec, Canada

M. Mina Dligui; Biomedical Telematics Laboratory Platform of the Quebec Respiratory Health Research Network, Sherbrooke, Quebec, Canada

Mrs Hiroko Yuzawa, MD, PhD(c); Department of Intensive Care Medicine, Tokyo, Japan

Mr Takehiro Tanabe, MD, PhD(c); Department of Intensive Care Medicine, Tokyo, Japan

Investigators

• Principal Investigator: Stephane Bourassa; Ste-Justine's Hospital

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Bourassa S, Noebert D, Dauphin M, Rambaud J, Kawaguchi A, Leger F, Beijer D, Fortier Y, Dligui M, Ivanovski H, Simard S, Jouvet P, Leclerc J. Acute care for patients exposed to a chemical attack: protocol for an international multicentric observational study. BMJ Open. 2022 Sep 29;12(9):e065015. doi: 10.1136/bmjopen-2022-065015.

• Responsible Party: Stephane Bourassa, Chief of CBRNE Team, St. Justine's Hospital
• ClinicalTrials.gov Identifier: NCT05026645
• Other Study ID Numbers: 2020-2561
• First Posted: August 30, 2021
• Last Update Posted: March 17, 2023
• Last Verified: March 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided
• Plan Description: At this stage, we do have any plan. However, for the interest of pursuing the research, that matter will require to be addressed in due time.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Stephane Bourassa, St. Justine's Hospital:

CBRNE Defence; Acute Settings; Pre-Hospital Settings; Decontamination; Protection; Respiratory Insults; Treatments

Additional relevant MeSH terms:

Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Syndrome; Emergencies; Disease; Pathologic Processes; Disease Attributes; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Lung Injury