Application of Wearable Technology in High-risk Surgical Patients in the Perioperative Period

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Complications; Surgery; Anesthesia; Adult ALL
• Intervention / Treatment: Device: LifeSignals 1AX Biosensor

Detailed Description

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.

In this study, the investigators aim to test the feasibility and patient compliance of remote wearable biosensor technology monitoring after major intracavity surgery. The remote monitoring combines vital sign observations (ECG, heart rate, temperature and respiratory rate) and a health status assessment questionnaire.

The study protocol has been approved by the Mater Misericordiae University Hospital Institutional Review Board (IRB) (Reference: 1/378/2207). Any protocol modifications will be submitted for the IRB review and approval.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• Ireland
  • Dublin 7, Ireland
    • Mater Misericordiae University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Adult patients recovering from major intra-cavity abdominal surgery being discharged from the Mater Misericordiae University Hospital in Dublin, Ireland.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Adult patients being discharged from hospital following intra-abdominal or pelvic surgery; Patient compliance with wearable biosensor monitoring after major intracavity surgery. The remote monitoring is made up of a wearable biosensor and a data-enabled relay device which will detect vital sign observations (ECG, heart rate, temperature and respiratory rate) and a health status assessment questionnaire.

Device: LifeSignals 1AX Biosensor; Biosensor worn by patients for 30-days after intra-abdominal or pelvic surgery on discharge from hospital

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compliance with wearable technology	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.	30-days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Unplanned hospital admission or GP visits	Retrospectively review any unplanned hospital admissions or GP visits in the first 30-days after hospital discharge	30-days after hospital discharge
Heart rate	Retrospectively review variations in heart rate (beats per minute) in the first 30-days after hospital discharge	30-days after hospital discharge
Temperature	Retrospectively review variations in temperature (degrees celsius) in the first 30-days after hospital discharge	30-days after hospital discharge
Respiratory Rate	Retrospectively review variations in respiratory rate (breaths per minute) in the first 30-days after hospital discharge	30-days after hospital discharge
Quality of recovery score (QoR15)	This score can range from 0 - 150, with higher scores relating to a more favourable recovery from surgery. This will be performed at day 30 after hospital discharge	30-days after hospital discharge

Collaborators and Investigators

• Sponsor: Mater Misericordiae University Hospital
• Collaborators: Health Service Executive, Ireland

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Actual): December 1, 2023
• Study Completion (Actual): December 1, 2023

Study Registration Dates

• First Submitted: November 30, 2022
• First Submitted That Met QC Criteria: November 30, 2022
• First Posted (Actual): December 8, 2022

Study Record Updates

• Last Update Posted (Actual): December 22, 2023
• Last Update Submitted That Met QC Criteria: December 19, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: 1/378/2207

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data for patients will strictly follow the agreed Data Protection Agreement (DPA) put in place by the Mater Misericordiae University Hospital

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No