Can Respiratory Rate Predict the Risk of Deterioration of Septic Patients

Completed

• Conditions: Sepsis

• Registration Number: NCT03752047
• Lead Sponsor: PMD Solutions

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

Study Timeline

• Study Start: 2017-03-23
• Primary Completion: 2017-09-09
• Study Completion: 2017-11-21
• Status Verified: 2018-11
• Study First Submitted: 2018-11-20
• Study First Submitted QC: 2018-11-21
• Last Update Submitted: 2018-11-21
• Study First Posted: 2018-11-23
• Last Update Posted: 2018-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
RespiraSense triggered escalation in SOFA score	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 Outcome Measures

Name	Time	Method
Upward trend in Respiratory Rate as a predictor of 30 day mortality	30 days after discharge	The secondary endpoint is the 30 day mortality rate after discharge.

Trial Locations

Locations (1)

Hospital of South West Jutland, Department of Emergency Medicine; 🇩🇰 Esbjerg, South West Jutland, Denmark