Respiratory Rate Measurement Methods. Clinical Trial
Official title:
Methods for the Measurement of Respiratory Rate
This study aims to investigate these research questions:
1. Is there a difference in the results obtained, when respiratory rate is measured
automatically by an electronic device (SensiumVitals® system, Sensium Healthcare)
compared with a research assistant using a criterion standard approach?
2. Is there a difference in the results obtained, when respiratory rate is measured
automatically by an electronic device (SensiumVitals® system, Sensium Healthcare)
compared with hospital staff's current clinical practice?
Respiratory rate is among the first vital signs to change when a deterioration in patient
conditions occurs, and that it is highly useful in identifying high-risk patients, patients
in pain, risk of death in patients treated for myocardial infarctions and medical patients
at risk of cardiac arrest.
Respiratory rate is one of the seven physiological parameters included in the Early Warning
Score (EWS), an aggregated track- and trigger-system for risk-stratification of patients in
hospital wards at risk of imminent clinical deterioration. EWS includes an escalation
protocol, defining when it is necessary for the ward staff to call for assistance and when
vital parameters should be measured again.
Manual measurement of respiratory rates is the standard in hospital wards in the Capital
Region of Denmark. During the measurement of respiratory rate, patients ideally have to lie
still and refrain from talking. This poses a difficulty in daily, clinical practice. Several
studies in hospital wards both using and not using an EWS-system report that respiratory
rate is often omitted when vital signs are measured.
Even if the respiratory rate is measured regularly, poor inter-observer agreement and
reproducibility of measured respiratory rates have been found. Respiratory rates recorded by
nurses have been reported to be generally higher than those measured by observers using a
standardised approach.
The EWS currently in use is validated using measurements obtained by normal nursing
practise. If there is an element of human influence on the measurement of respiratory rate,
automation could affect the prognostic properties of EWS in an unpredictable way, even if
the automatically measured respiratory rates more reliably reflect the patients' physiology
than current clinical practise.
If a systematic difference between the recordings by staff and the electronic devices
currently on the market exists, this could have an implication on the EWS scores and
subsequently, escalation protocols for patients with elevated EWS could be affected. If this
is the case, EWS might even have to be re-validated using machine-measured respiratory
rates.
Thus, even as there could be a number of advantages of automating the measurements of
respiratory rates in hospital wards, due considerations are required before ward staff's
manual measurement of respiratory rate can be replaced by measurements obtained from
electronic devices. The purpose of this study is to evaluate if there is a systematic
difference in the respiratory rate measurements performed by an electronic device
(SensiumVitals® system, Sensium Healthcare) compared with the measurements performed by a
research assistant using a criterion standard approach and the ward staff's usual
measurements.
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Intervention Model: Single Group Assignment, Primary Purpose: Diagnostic