Can Respiratory Rate Predict the Risk of Deterioration of Septic Patients

NCT03752047 | Completed

• 1 other identifier: PMD-CS-006ii
• Study Type: observational
• Target: 132
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis

Outcome Measures

Primary Outcomes (1)

• RespiraSense triggered escalation in SOFA score

  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.

  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 Outcomes (1)

• Upward trend in Respiratory Rate as a predictor of 30 day mortality

  30 days after discharge

Other Outcomes (1)

• Upward trend in Respiratory Rate as a predictor of 30 day readmission.

  30 days after discharge

Study Arms (1)

Suspicion of Sepsis

Patients who are admitted and are diagnosed with sepsis will be recruited for this investigation.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

For this investigation, the population of interest are patients admitted to the Acute Medical Unit (AMU) with sepsis or that develop sepsis during their admission.

You may qualify if:

• ≥ 18 Years
• Admitted for a minimum of 12 hours
• Have been diagnosed with sepsis
• Sepsis diagnosis confirmed by documented or suspected infection (ordering of blood culture or other microbiological investigation by the clinician) and ≥1 of the following presenting within the first 4 hours of admission:
• Fever or hypothermia, Core temperature \> 38.3 or \< 36 °C
• Heart rate \> 90/min
• Respiratory rate \> 20/min
• Altered consciousness/mental state, defined as GCS \< 15
• Hyperglycemia, (BS \> 6.7 mmol/L non-diabetic)
• LKC \> 12 \*10\^9 or \< 4\*10\^9,
• Normal LKC with \> 10 % immature cells,
• CRP \> highest normal local lab. Interval
• Hypotension: Systolic BP \<90 mmHg, or drop in systolic BP \> 40
• Hypoxemia: PaO2 \< 8.5 Kpa or PaO2/FiO2 \< 40 or tissue perfusion: P-lactate \> 1.6
• Creatinine . 177 µmol/L

You may not qualify if:

• Allergic to medical grade skin adhesive
• Pregnant women during second and third trimester
• Continuous long term steroid use. Defined as not using steroids in the 4 weeks previous to enrolment
• Patients under the influence of substance abuse (drug or alcohol) that may interfere with their ability to cooperate and comply with the investigation procedures
• Any disorder, including cognitive dysfunction, which would affect the ability to accurately complete questionnaires and freely give full informed consent. This will be determined by the Abbreviated Mental Test Score (AMT) Cannot be followed a second time if admitted again at a later date during the study period

Sponsors & Collaborators

• PMD Solutions: lead
• Esbjerg Hospital - University Hospital of Southern Denmark: collaborator

Study Sites (1)

Hospital of South West Jutland, Department of Emergency Medicine

Esbjerg, South West Jutland, DK-6700, Denmark

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2018
• First Posted: November 23, 2018
• Study Start: March 23, 2017
• Primary Completion: September 9, 2017
• Study Completion: November 21, 2017
• Last Updated: November 23, 2018

Record last verified: 2018-11

Locations

DK (1)