Currently submitted to: JMIR Research Protocols
Date Submitted: Jul 11, 2019
Open Peer Review Period: Jul 15, 2019 - Jul 29, 2019
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An evaluation of agreement of breathing rates measured by a novel device, manual counting and other techniques used in clinical practice: Protocol for the VENTILATE Study
Respiratory Rate (RR) is the most sensitive physiological observation to predict clinical deterioration on hospital wards and poor clinical monitoring has been highlighted as a primary contributor to avoidable mortality. Patients in Intensive Care have their RR monitored continuously but this equipment is rarely available on general hospital wards.
The primary objective is to assess the accuracy of the RespiraSense device in comparison to other methods currently used in clinical practice. The secondary objective is to assess the accuracy of the RespiraSense device in participants in different positions and when reading aloud.
A single-centre, prospective observational study will investigate the agreement of the RespiraSense device as compared to other device measurements (capnography, electrocardiogram [ECG]) and the current standard measurement of RR (manual counting by a trained healthcare professional). The different methods will be employed concurrently on the same participant as part of a single study visit.
This study has not yet begun recruitment. It is expected to complete data collection approximately 2 months after opening.
The VENTILATE study will provide further validation of the use of the RespiraSense device in subjects with abnormal respiratory rates.
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