Regions: Inuvialuit Settlement Region, Gwich'in Settlement Area, Sahtu Settlement Area, Dehcho Region, North Slave Region, South Slave Region
Tags: health, health care, disease
Principal Investigator: | Kandola, Kami (1) |
Licence Number: | 14702 |
Organization: | Health Social Services |
Licensed Year(s): |
2010
|
Issued: | Apr 28, 2010 |
Project Team: | Dr. Kami Kandola (Principal Investigator, Stanton Territorial Health Authority), Kathie Pender (Research Coordinator, Stanton Territorial Health Authority) |
Objective(s): To describe the presenting patient characteristics, organ dysfunction, clinical outcomes and resource needs of influenza-H1N1-related critical illness and acute lung injury among children and adults in Canada.
Project Description: Primary objective: To describe the presenting patient characteristics, organ dysfunction, clinical outcomes and resource needs of influenza-H1N1-related critical illness and acute lung injury among children and adults in Canada. Our primary endpoint will be survival and the secondary endpoint will be critical care-free days, both at 90 days after onset of critical illness. Secondary main objectives: (1) To determine capacity of critical care in Canada (2) To provide descriptions of specific sub-groups of patients (e.g. children, pregnant women, Aboriginal Canadians, healthcare workers) who may be at particular risk The investigator will retrospectively study consecutive critically ill adult patients with confirmed, probable or suspected influenza A (H1N1), in addition to other forms of influenza in affected areas. Study patients will be identified by examining admission logs of all patients to hospital and critical care areas, in collaboration with critical care and infectious diseases physicians in each participating hospital and regional health authorities. To be eligible, study participants must meet the following case definitions that were developed by the WHO, Centers for Disease Prevention and Control, and the National Microbiology Laboratory: Confirmed - a person with new onset of fever and respiratory illness with laboratory confirmed influenza A (H1N1) virus infection; Probable – a person with new onset of fever and respiratory illness who is positive for influenza A, but negative for H1 and H3 or positive for influenza A by an influenza rapid test or an influenza immunofluorescence assay (IFA) and meets criteria for a suspected case; Possible – a person with new onset of fever and respiratory illness within 7 days of close contact with a person who is a confirmed case of influenza A (H1N1) virus infection, or within 7 days of travel to a community either locally or internationally where there are one or more confirmed influenza A (H1N1) cases, or resides in a community where there are one or more confirmed influenza A (H1N1) cases. Critically ill patients are defined as those: • admitted to an adult or pediatric ICU; • or requires mechanical ventilation, • or must breath in air with a concentration greater than or equal to 60% oxygen, • or requires an intravenous infusion of specified drugs used to manage heart function, • or have another compelling reason to be called ‘critically ill’. The site Research Coordinator will collect data from the eligible patient charts and enter it in the web-based case report form. Training and a code to access the web site will be provided. This study will measure and report the impact of H1N1 critical illness on the health care system, document the clinical epidemiology, patient characteristics, resource requirements and clinical outcomes over the course of this pandemic. This will help to document the at-risk population, to focus prevention policies (e.g. vaccination) and to optimize information delivered to Canadian citizens. The data collected will be used by provincial, national and international partners to provide the combination of clinical information and impact on health services. The data will be analyzed to provide information regarding the capacity to care for critically ill patients in all areas of Canada, the clinical presentation of critical illness among children and adults, the differences among racial and other sub-groups, and to explore associations between patient and treatment based variables and clinical outcomes. This will allow a detailed description of degree of support, resources and costs necessary to care for these patients and how this burden will impact our hospitals, ICUs and healthcare system. Participation in this data collection will assist to ensure that we are able to provide a comprehensive understanding of the resource implications and epidemiology of severe H1N1 disease. This information can inform policy decisions regarding the optimal use of limited resources during a pandemic, and further provide the information on natural history and risk factors that are necessary to facilitate clinical trials to optimize therapy. Scholarly papers have been and will be written, based on the data collected, and published for presentation and review at scientific meetings. Periodic notification of recent publications will be sent to the sites. The Northwest Territories’ results will be available for local presentations to the community. Interested parties can provide lay summaries of the findings. Video or on line web casts can be provided to disseminate the information. Examples of papers written from the H1N1 first wave results: Critically Ill Patients With 2009 Influenza A(H1N1) Infection in Canada: conducted to describe characteristics, treatment, and outcomes of critically ill patients in Canada with 2009 influenza A(H1N1) infection. JAMA 302: 1872-1879. Available from: http://jama.ama-assn.org/cgi/content/full/2009.1496?eaf Critically Ill Patients With 2009 Influenza A(H1N1) in Mexico JAMA 302: 1880-1887. Available from: http://jama.ama-assn.org/cgi/content/abstract/302/17/1880?maxtoshow=&eaf The fieldwork for this study will be conducted from April 29, 2010 to December 31, 2010.