Sepsis Clinical Trial
Official title:
Can Respiratory Rate Predict the Risk of Deterioration of Septic Patients
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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