Severe Pandemic H1N1 Infection in ICU: Comparative Resource Utilization

The main purpose of this study is to review the resource utilization of severe adult H1N1 pneumonia undergoing antiviral and oxygen therapy, mechanical ventilation and support with pulmonary rescue therapies ( nitric oxide, ECMO, HFO) in critically ill patients in Winnipeg. Secondary objectives include, comparison of resource utilization to other similar disorders (viral pneumonia, bacterial pneumonia, septic shock, ARDS). The investigators will also look at the percentage of patients that required ICU care as compared to those who could be cared for on medical wards. The investigators will determine the resources used by both groups and compare. Finally the investigators will record the frequency of chronic comorbidities in hospitalized adult H1N1 patients.

Study Overview

• Status: Completed
• Conditions: Novel H1N1 Influenzal Acute Respiratory Infection
• Intervention / Treatment: Other: We will compare the resources used by both groups

• Study Type: Observational
• Enrollment (Actual): 400

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3A 1R9
      • Health Sciences Centre, Winnipeg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with severe adult H1N1 pneumonia undergoing antiviral and oxygen therapy, mechanical ventilation and support with pulmonary rescue therapies ( nitric oxide, ECMO, HFO) in critically ill patients in Winnipeg. Patients with other similar disorders (viral pneumonia, bacterial pneumonia, septic shock, ARDS)that may require some of the same treatments.

Description

Inclusion Criteria:

1. > 18years,
2. Suspected or confirmed influenza (Appendix A)
3. Requirement for ICU admission due to respiratory distress or critical illness defined as one of:a) Inspired oxygen need of >50% for at least 4 hours (For FiO2 for non-intubated patients see Appendix B) b) mechanical ventilation c) Patient is receiving inotrope or vasopressor

Exclusion Criteria:

1. Age less than 18 years

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Severe H1N1 pneumonia in adult patients; Severe adult H1N1 pneumonia patients undergoing antiviral and oxygen therapy, mechanical ventilation and support with pulmonary rescue therapies ( nitric oxide, ECMO, HFO)in Winnipeg	Other: We will compare the resources used by both groups; The main purpose of this study is to review the resource utilization. Secondary objectives include, comparison of resource utilization to other similar disorders (viral pneumonia, bacterial pneumonia, septic shock, ARDS). We will also look at the percentage of patients that required ICU care as compared to those who could be cared for on medical wards. We will determine the resources used by both groups and compare. Finally we will record the frequency of chronic comorbidities in hospitalized adult H1N1 patients.
Severe pneumonia in adults not H1N1; Patients admitted to the hospital and/or ICU with viral pneumonia, bacterial pneumonia, septic shock, ARDS in Winnipeg	Other: We will compare the resources used by both groups; The main purpose of this study is to review the resource utilization. Secondary objectives include, comparison of resource utilization to other similar disorders (viral pneumonia, bacterial pneumonia, septic shock, ARDS). We will also look at the percentage of patients that required ICU care as compared to those who could be cared for on medical wards. We will determine the resources used by both groups and compare. Finally we will record the frequency of chronic comorbidities in hospitalized adult H1N1 patients.

Collaborators and Investigators

• Sponsor: University of Manitoba
• Collaborators: GlaxoSmithKline
• Investigators: Principal Investigator: Anand Kumar, MD, Health Sciences Centre, Winnipeg

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: December 1, 2011
• First Submitted That Met QC Criteria: December 2, 2011
• First Posted (Estimate): December 5, 2011

Study Record Updates

• Last Update Posted (Estimate): December 2, 2015
• Last Update Submitted That Met QC Criteria: December 1, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Infections; Communicable Diseases; Respiratory Tract Infections
• Other Study ID Numbers: pandemic001; H2009:175 (Other Identifier: University of Manitoba Research Ethics Board Identifier:)