Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05642988 |
| Other study ID # |
1/378/2207 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2023 |
| Est. completion date |
December 1, 2023 |
Study information
| Verified date |
December 2023 |
| Source |
Mater Misericordiae University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
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.
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.
