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| Name | Class |
|---|---|
| Esbjerg Hospital - University Hospital of Southern Denmark | OTHER |
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The primary objective is to determine if the trend in Respiratory Rate measurements provided by the device under investigation can be used to predict an increase in Sequential/Sepsis-related Organ Failure Assessment (SOFA) score.
The RR trend will be measured as the difference between the RR recorded by the device at a point 15 minutes after commencement of treatment, as per the standard of care for patients suspected of being septic, and a point 3 hours following this.
The primary objective is to determine if the trend in Respiratory Rate measurements provided by the device under investigation can be used to predict an increase in Sequential/Sepsis-related Organ Failure Assessment (SOFA) score.
The RR trend will be measured as the difference between the RR recorded by the device at a point 15 minutes after commencement of treatment, as per the standard of care for patients suspected of being septic, and a point 3 hours following this.
Secondary objective The secondary objective is to test if Respiratory Rate can help identify patients at increased risk of 30 day mortality.
The null Hypotheses of the planned comparison is that there is no difference in the RR trend in the 3 hours following commencement of treatment for sepsis in subjects who have an increase in SOFA score by 2 or more points and those who have a change in SOFA score of +1 or less.
The change in SOFA score will be measured at point of commencement of treatment and at 6 hours following commencement of treatment, or nearest available SOFA score determination.
Respiratory Rate captured during admission could have a predictive course for cohort of interest
The time points for reviewing the RR will be as follows:
(i) The last measurement (ii) The trend over 3 hours following commencement of treatment as per the standard of care for patients suspected of being septic.
(iii) The trend over the entire duration of admission
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Suspicion of Sepsis | Patients who are admitted and are diagnosed with sepsis will be recruited for this investigation. |
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| Measure | Description | Time Frame |
|---|---|---|
| RespiraSense triggered escalation in SOFA score | Escalation of SOFA score by 2 or more points. The primary endpoint will be evaluated with an ANCOVA with escalation of SOFA score by 2 or more points as a factor and mean RR in the first hour of treatment as a covariate. | 15 minutes after commencement of treatment, as per the standard of care for patients suspected of being septic, and a point 3 hours following this. |
| Measure | Description | Time Frame |
|---|---|---|
| Upward trend in Respiratory Rate as a predictor of 30 day mortality | The secondary endpoint is the 30 day mortality rate after discharge. | 30 days after discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Upward trend in Respiratory Rate as a predictor of 30 day readmission. | The secondary endpoint is the 30 day readmission rate after discharge. | 30 days after discharge |
Inclusion criteria
Sepsis diagnosis confirmed by documented or suspected infection (ordering of blood culture or other microbiological investigation by the clinician) and ≥1 of the following presenting within the first 4 hours of admission:
Exclusion criteria
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For this investigation, the population of interest are patients admitted to the Acute Medical Unit (AMU) with sepsis or that develop sepsis during their admission.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of South West Jutland, Department of Emergency Medicine | Esbjerg | South West Jutland | DK-6700 | Denmark |
Data can be shared upon request.
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |