Document is current

Article History

Received: 29 July 2019

Accepted: 24 September 2019

First Online: 17 October 2019

Ethics approval and consent to participate

: Ethics approval was given for the study, by the regional ethics committee, REC 17/NW/0533, and the Health Research Authority (HRA) permission to proceed was issued, IRAS ID 215339. The study was also submitted to the Medicines and Healthcare products Regulatory Agency (MHRA) which confirmed that it did not fall within its trial regulations.Vital signs documentation and sepsis screening are part of routine care and consent is not required when the device is used to record these changes. However, posters outlining the purpose of the study will be displayed in the in-patient wards, giving permission to parents to decline the use of their child’s anonymised vital signs data in the study analysis.Consent will be collected for the families of children who are transferred to critical care following deterioration, so that additional data can be captured about the clinical course, and to ascertain the indirect financial cost to families associated with critical deterioration. Consent will also be sought from a selection of patients who did and did not deteriorate to explore the acceptability of being monitored using this technology. The consent process incorporates statements about the use of anonymised data for publication.Consent will also be sought from the staff who agree to participate in the evaluation of clinical utility of the devices.

: Consent for publication is incorporated within the consent form used to document consent for participants, and their families. This explicitly states that no patient identifiable data will be published.

: The authors declare that they have no competing interests.