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临床试验/NCT05642988
NCT05642988已完成不适用

Application of Wearable Technology in High-risk Surgical Patients in the Perioperative Period: a Feasibility Study

Mater Misericordiae University Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Compliance with wearable technology

研究概览

简要总结

Unrecognised changes in patients' vital signs after surgery can result in preventable complications. Current standard practice includes routine monitoring of patient vital signs up until hospital discharge.

Upon discharge from hospital, all forms of routine vital sign monitoring ceases. The availability and use of wearable technology in healthcare is increasing rapidly. The role of wearable technology in the remote monitoring of patients at high-risk of post-operative complications and hospital readmission after discharge from hospital is unclear.

This pilot study is aimed to assess the feasibility of using wearable technology in patients recovering from major intracavity surgery after hospital discharge in the Irish healthcare setting.

详细描述

Patients undergoing major abdominal and pelvic surgery can have re-admission rates of over 20% in the first 90-days after surgery.

In Ireland the 30-day mortality following emergency abdominal surgery is 6.6%, and 90-day mortality 11.6% (1). Furthermore, 20% of post-operative deaths occur after hospital discharge in those over 80 years of age, of which over 95% occurs during the first six-weeks (2).

Despite this high risk, many patients are discharged home from hospital when medically fit and continuous monitoring discontinues. In hospital, patient monitoring is routine to identify patient deterioration at an early stage using the national early warning score (NEWS), which consists of the following clinical observations: heart rate, blood pressure, temperature, respiratory rate, oxygen saturation and level of consciousness. This monitoring is done routinely in the hospital ward at least every four hours. This monitoring stops when patients are discharged from hospital. Patients discharged are given general advice for recovery and, as part of current practice, are advised to contact their General Practitioner (GP) or emergency department if feeling unwell. Despite this, mortality in the post-discharge period accounts for nearly a quarter of all post-operative deaths.

Home monitoring of patients with chronic conditions has previously been shown to be of some utility. Recently, during the COVID-19 pandemic, remote home monitoring of patients diagnosed with COVID-19 who did not meet hospital admission criteria were managed by smartphone application and peripheral pulse oximetry.

To date, no previously published studies have adopted home monitoring for a patient group that is at a high risk of re-admission. In addition, simple questionnaires used to monitor postoperative recovery (such as the QoR-15) exist, that are reflective of a patient's current health status, but they have not been used to monitor patients after hospital discharge.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Over 18 years of age
  • Scheduled to undergo or recently undergone major intra-cavity abdominal surgery
  • Able to give informed written consent to participate

排除标准

  • Deemed unfit for surgery
  • Unable or unwilling to comply with remote monitoring for any reason
  • Unable or unwilling to fill in a questionnaire in English

结局指标

主要结局

Compliance with wearable technology

时间窗: 30-days

Assess compliance with remote monitoring in the first 30-days after hospital discharge following intra-abdominal or pelvic surgery. Compliance will be defined as wearing the biosensor for at least 20 hours per day.

次要结局

  • Temperature(30-days after hospital discharge)
  • Unplanned hospital admission or GP visits(30-days after hospital discharge)
  • Heart rate(30-days after hospital discharge)
  • Respiratory Rate(30-days after hospital discharge)
  • Quality of recovery score (QoR15)(30-days after hospital discharge)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Pádraig Ó Scanaill

Consultant Anaesthetist

Mater Misericordiae University Hospital

研究点 (1)

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