Status:
COMPLETED
Can Respiratory Rate Predict the Risk of Deterioration of Septic Patients
Lead Sponsor:
PMD Solutions
Collaborating Sponsors:
Esbjerg Hospital - University Hospital of Southern Denmark
Conditions:
Sepsis
Eligibility:
All Genders
18+ years
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 Fai...
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 Fai...
Eligibility Criteria
Inclusion
- Inclusion criteria
- ≥ 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
- Acute oliguria (Diuresis per hour ,0.5 ml/kg/t or 45 ml/t in 2 hours)
- Coagulopathy: Spontaneous INR \> 1.5, or apt \> 60 sec, thrombocytopenia
- Paralytic ileus (absence of bowel sounds)
- Hyperbilirubinemia \> 34µmol/L
- Are willing to voluntarily sign a statement of informed consent to participate in this investigation
- Exclusion criteria
- 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
Exclusion
Key Trial Info
Start Date :
March 23 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 21 2017
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT03752047
Start Date
March 23 2017
End Date
November 21 2017
Last Update
November 23 2018
Active Locations (1)
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1
Hospital of South West Jutland, Department of Emergency Medicine
Esbjerg, South West Jutland, Denmark, DK-6700