Acute Respiratory Distress Syndrome Clinical Trial
— CBRNEObsOfficial title:
Acute Care For Patients Exposed to a Chemical, Biological, Radiological, Nuclear, Explosive: Attack: Protocol For An International Multicentric Observational Study
Verified date | November 2023 |
Source | St. Justine's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Observation study measuring medical response in contaminated environment.
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. |
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 |
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 |
United States, Canada, France, Japan,
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). |
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