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Clinical Trials/NCT03752047
NCT03752047
Completed
Not Applicable

Can Respiratory Rate Predict the Risk of Deterioration of Septic Patients

PMD Solutions1 site in 1 country132 target enrollmentMarch 23, 2017
ConditionsSepsis

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

Registry
clinicaltrials.gov
Start Date
March 23, 2017
End Date
November 21, 2017
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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)

Study Sites (1)

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