NCT05026645

Brief Summary

Observation study measuring medical response in contaminated environment.

Trial Health

82
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
129mo left

Started Oct 2020

Longer than P75 for all trials

Geographic Reach
6 countries

15 active sites

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress35%
Oct 2020Dec 2036

Study Start

First participant enrolled

October 1, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 18, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 30, 2021

Completed
15.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2036

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2036

Last Updated

October 1, 2025

Status Verified

September 1, 2025

Enrollment Period

16.1 years

First QC Date

August 18, 2021

Last Update Submit

September 29, 2025

Conditions

Keywords

CBRNE DefenceAcute SettingsPre-Hospital SettingsDecontaminationProtectionRespiratory InsultsTreatments

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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).

  • 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).

  • 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).

  • 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).

Study Arms (8)

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)Procedure: Protection (clinician and patient)Procedure: Decontamination (clinician and patient)

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)Procedure: Protection (clinician and patient)Procedure: Decontamination (clinician and patient)

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)Procedure: Protection (clinician and patient)Procedure: Decontamination (clinician and patient)

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)Procedure: Protection (clinician and patient)Procedure: Decontamination (clinician and patient)

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)Procedure: Protection (clinician and patient)Procedure: Decontamination (clinician and patient)

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)Procedure: Protection (clinician and patient)Procedure: Decontamination (clinician and patient)

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)Procedure: Protection (clinician and patient)Procedure: Decontamination (clinician and patient)

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)Procedure: Protection (clinician and patient)Procedure: Decontamination (clinician and patient)

Interventions

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).

Clinician (adult) injured by duties circumstancesClinician (adult) whom performs his/her clinical interventionsDiagnosed with chronic disease(s) inflicted by a CBRNE weaponElderly inflicted by a CBRNE weaponInfant inflicted by a CBRNE weaponMen inflicted by a CBRNE weaponWomen inflicted by a CBRNE weaponadult inflicted by a CBRNE weapon

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.

Clinician (adult) injured by duties circumstancesClinician (adult) whom performs his/her clinical interventionsDiagnosed with chronic disease(s) inflicted by a CBRNE weaponElderly inflicted by a CBRNE weaponInfant inflicted by a CBRNE weaponMen inflicted by a CBRNE weaponWomen inflicted by a CBRNE weaponadult inflicted by a CBRNE weapon

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 circumstancesClinician (adult) whom performs his/her clinical interventionsDiagnosed with chronic disease(s) inflicted by a CBRNE weaponElderly inflicted by a CBRNE weaponInfant inflicted by a CBRNE weaponMen inflicted by a CBRNE weaponWomen inflicted by a CBRNE weaponadult inflicted by a CBRNE weapon

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Director, Unconventional Weapons & Technology Division, National Consortium for the Study of Terrorism and Responses to Terrorism University of Maryland

College Park, Maryland, 20740, United States

Location

Centre for Defence and Security Studies, University of Manitoba

Winnipeg, Manitoba, R3T 2N2, Canada

Location

Royal Canadian Medical Corps

Ottawa, Ontario, K1A0K2, Canada

Location

École de Technologie Supérieure Université du Québec

Montreal, Quebec, H3C 1K3, Canada

Location

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

Montreal, Quebec, H3T 1C5, Canada

Location

Research Centre, Quebec Heart and Lung Institute, Laval University

Québec, Quebec, G1V 4G5, Canada

Location

Medical Intelligence CBRNE Inc.

Québec, Quebec, G1V0C8, Canada

Location

Biomedical Telematics Laboratory Platform of the Quebec Respiratory Health Research Network

Sherbrooke, Quebec, J1K 2R1, Canada

Location

University of Finance and Administration Department of Criminology and Forensic Disciplines

Prague, Prague, 10100, Czechia

Location

Sorbonne University

Paris, Île-de-France Region, France

Location

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

Tokyo, Shinjuku-ku, Japan

Location

Department of Critical care, Miyagi Children's Hospital

Tokyo, Japan

Location

Department of Disaster Medical Management, The University of Tokyo Hospital

Tokyo, Japan

Location

Surrey and Sussex Healthcare NHS Trust

Surrey Quays, Redhill, RH1 5RH, United Kingdom

Location

CBRNE World Journal

Winchester, SO23 8UT, United Kingdom

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Respiratory Distress SyndromePulmonary Atelectasis

Interventions

Decontamination

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Intervention Hierarchy (Ancestors)

Public Health PracticePublic HealthEnvironment and Public Health

Study Officials

  • Stephane Bourassa

    Ste-Justine's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of CBRNE Team

Study Record Dates

First Submitted

August 18, 2021

First Posted

August 30, 2021

Study Start

October 1, 2020

Primary Completion (Estimated)

November 1, 2036

Study Completion (Estimated)

December 1, 2036

Last Updated

October 1, 2025

Record last verified: 2025-09

Locations