The Medical Management in Patients Exposed to Weapons of Mass Destruction

Acute Respiratory Distress Syndrome Clinical Trial

— CBRNEObs  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05026645
• Other study ID #: 2020-2561
• Status: Enrolling by invitation
• Start date: October 1, 2020
• Est. completion date: December 1, 2036

Study information

• Verified date: November 2023
• Source: St. Justine's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Observation study measuring medical response in contaminated environment.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1000
• Est. completion date: December 1, 2036
• Est. primary completion date: November 1, 2036
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Chemical Injury
• Distress Respiratory Syndrome
• Emergencies
• Medical Emergencies
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

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).
• 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.
• 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.

Locations

Country	Name	City	State
Canada	Research Center of the CHU St-Justine, University of Montreal	Montreal	Quebec
Canada	Royal Canadian Medical Corps	Ottawa	Ontario
Canada	Medical Intelligence CBRNE Inc.	Quebec
Canada	Research Centre, Quebec Heart and Lung Institute, Laval University	Quebec
Canada	Biomedical Telematics Laboratory Platform of the Quebec Respiratory Health Research Network	Sherbrooke	Quebec
Canada	Centre for Defence and Security Studies, University of Manitoba	Winnipeg	Manitoba
Canada	School of Nursing, Manitoba University	Winnipeg	Manitoba
France	Sorbonne University	Paris	Ile De France
Japan	Department of Critical care, Miyagi Children's Hospital	Tokyo
Japan	Department of Disaster Medical Management, The University of Tokyo Hospital	Tokyo
Japan	Tokyo Women's Medical University, Department of Intensive Care Medicine	Tokyo	Shinjuku-ku
United States	Director, Unconventional Weapons & Technology Division, National Consortium for the Study of Terrorism and Responses to Terrorism University of Maryland	College Park	Maryland

Sponsors (10)

Lead Sponsor

Collaborator

St. Justine's Hospital

Biomedical Telematics Laboratory, Quebec Respiratory Health Research Network, Sherbrooke, Canada, Centre for Defence and Security Studies, University of Manitoba, Winnipeg, Canada, Department of Intensive Care Medicine, Tokyo, Japan, Medical Intelligence CBRNE inc.; Quebec City, Canada, Quebec Heart and Lung Institute, Quebec City, Canada, Sorbonne University, Tokyo University, Tokyo Women's Medical University, University of Maryland, College Park

Countries where clinical trial is conducted

United States,  Canada,  France,  Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).
Secondary	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).
Secondary	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).
Secondary	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).