可穿戴传感器与数字警报系统在二级医疗保健中的应用：一项评估临床结果的真实世界前瞻性研究方案

Implementation of Wearable Sensors and Digital Alerting Systems in Secondary Care: Protocol for a Real-World Prospective Study Evaluating Clinical Outcomes.

作者信息

Iqbal Fahad Mujtaba, Joshi Meera, Khan Sadia, Ashrafian Hutan, Darzi Ara

机构信息

Division of Surgery and Cancer, Imperial College London, London, United Kingdom.

West Middlesex University Hospital, London, United Kingdom.

出版信息

JMIR Res Protoc. 2021 May 4;10(5):e26240. doi: 10.2196/26240.

DOI:10.2196/26240

PMID:33944790

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8132972/

Abstract

BACKGROUND

Advancements in wearable sensors have caused a resurgence in their use, particularly because their miniaturization offers ambulatory advantages while performing continuous vital sign monitoring. Digital alerts can be generated following early recognition of clinical deterioration through breaches of set parameter thresholds, permitting earlier intervention. However, a systematic real-world evaluation of these alerting systems has yet to be conducted, and their efficacy remains unknown.

OBJECTIVE

The aim of this study is to implement wearable sensors and digital alerting systems in acute general wards to evaluate the resultant clinical outcomes.

METHODS

Participants on acute general wards will be screened and recruited into a trial with a pre-post implementation design. In the preimplementation phase, the SensiumVitals monitoring system, which continuously measures temperature, heart, and respiratory rates, will be used for monitoring alongside usual care. In the postimplementation phase, alerts will be generated from the SensiumVitals system when pre-established thresholds for vital parameters have been crossed, requiring acknowledgement from health care staff; subsequent clinical outcomes will be analyzed.

RESULTS

Enrolment is currently underway, having started in September 2017, and is anticipated to end shortly. Data analysis is expected to be completed in 2021.

CONCLUSIONS

This study will offer insight into the implementation of digital health technologies within a health care trust and aims to describe the effectiveness of wearable sensors for ambulatory continuous monitoring and digital alerts on clinical outcomes in acute general ward settings.

TRIAL REGISTRATION

ClinicalTrials.gov NCT04638738; https://clinicaltrials.gov/ct2/show/NCT04638738.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/26240.

摘要

背景

可穿戴传感器的进步使其使用再度兴起，特别是因为其小型化在进行连续生命体征监测时具有动态监测优势。通过突破设定参数阈值早期识别临床恶化情况后可生成数字警报，从而实现更早干预。然而，尚未对这些警报系统进行系统的实际评估，其有效性仍不明确。

目的

本研究旨在将可穿戴传感器和数字警报系统应用于急性普通病房，以评估由此产生的临床结果。

方法

对急性普通病房的参与者进行筛查并招募入一项采用实施前-实施后设计的试验。在实施前阶段，将使用持续测量体温、心率和呼吸频率的SensiumVitals监测系统与常规护理一起进行监测。在实施后阶段，当生命体征参数超过预先设定的阈值时，SensiumVitals系统将生成警报，医护人员需予以确认；随后对临床结果进行分析。