Can Respiratory Rate Predict the Risk of Deterioration of Septic Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Sepsis
- Sponsor
- PMD Solutions
- Enrollment
- 132
- Locations
- 1
- Primary Endpoint
- RespiraSense triggered escalation in SOFA score
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief 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
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
RespiraSense triggered escalation in SOFA score
Time Frame: 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.
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.
Secondary Outcomes
- Upward trend in Respiratory Rate as a predictor of 30 day mortality(30 days after discharge)