Can Respiratory Rate Predict the Risk of Deterioration of Septic Patients
Can Respiratory Rate Predict the Risk of Deterioration of Septic Patients
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.
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
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