The Medical Management in Patients Exposed to Weapons of Mass Destruction

Официальное название

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

Обзор

Observation study measuring medical response in contaminated environment.

Подробное описание

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.

Вмешательства

• Процедура 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).
• Процедура 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.
• Процедура 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 c

Первичные конечные точки

• Intervention and location [Срок оценки: At the patient's admission at the hospital emergency room (i.e.: end-point of the medical extraction/evacuation).]

Вторичные конечные точки (4)

• Contamination is under-control due to efficient protective measures applied during a medical extraction/evacuation [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: At the patient's admission at the hospital emergency room (i.e.: end-point of the medical extraction/evacuation).]

Критерии участия

Критерии включения

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.

Критерии исключения

A negative response to any of the inclusion criteria results in an exclusion.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Канада · 7 центров

• Centre for Defence and Security Studies, University of Manitoba — Winnipeg
• Royal Canadian Medical Corps — Ottawa
• École de Technologie Supérieure Université du Québec — Montreal
• Research Center of the CHU St-Justine, University of Montreal — Montreal
• Research Centre, Quebec Heart and Lung Institute, Laval University — Québec
• Medical Intelligence CBRNE Inc. — Québec
• Biomedical Telematics Laboratory Platform of the Quebec Respiratory Health Research Networ — Sherbrooke

Япония · 3 центра

• Tokyo Women's Medical University, Department of Intensive Care Medicine — Tokyo
• Department of Critical care, Miyagi Children's Hospital — Tokyo
• Department of Disaster Medical Management, The University of Tokyo Hospital — Tokyo

Великобритания · 2 центра

• Surrey and Sussex Healthcare NHS Trust — Surrey Quays
• CBRNE World Journal — Winchester

США · 1 центр

• Director, Unconventional Weapons & Technology Division, National Consortium for the Study — College Park

Чехия · 1 центр

• University of Finance and Administration Department of Criminology and Forensic Discipline — Prague

Франция · 1 центр

• Sorbonne University — Paris

Публикации

• 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. PMID 36175098

Идентификаторы

NCT: NCT05026645 · 2020-2561

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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