NCT03752047

Can Respiratory Rate Predict the Risk of Deterioration of Septic Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 132 (actual)
• Sponsor: PMD Solutions · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

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.

Detailed description

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

Conditions

• Sepsis

Timeline

• Start date: 2017-03-23
• Primary completion: 2017-09-09
• Completion: 2017-11-21
• First posted: 2018-11-23
• Last updated: 2018-11-23

Locations

1 site across 1 country: Denmark