Adult ALLNCT05642988
Application of Wearable Technology in High-risk Surgical Patients in the Perioperative Period
An observational study of Adult ALL and Surgery, run by Mater Misericordiae University Hospital at 1 site in Ireland.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Adult ALL, Surgery, Anesthesia
- What is being tested?
- LifeSignals 1AX Biosensor
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteIreland
- Study dates
- 1 Mar 2023to 1 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients recovering from major intra-cavity abdominal surgery being discharged from the Mater Misericordiae University Hospital in Dublin, Ireland.
Who may be able to join
- Over 18 years of age
- Scheduled to undergo or recently undergone major intra-cavity abdominal surgery
- Able to give informed written consent to participate
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Adult ALL, Surgery, Anesthesia, Postoperative Complications
- Being tested
- LifeSignals 1AX Biosensor
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LifeSignals 1AX BiosensorDevice
Biosensor worn by patients for 30-days after intra-abdominal or pelvic surgery on discharge from hospital
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: LifeSignals 1AX Biosensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30-days
Secondary outcomes (5)
Unplanned hospital admission or GP visits
Retrospectively review any unplanned hospital admissions or GP visits in the first 30-days after hospital discharge
Measured: 30-days after hospital discharge
Heart rate
Retrospectively review variations in heart rate (beats per minute) in the first 30-days after hospital discharge
Measured: 30-days after hospital discharge
Temperature
Retrospectively review variations in temperature (degrees celsius) in the first 30-days after hospital discharge
Measured: 30-days after hospital discharge
Respiratory Rate
Retrospectively review variations in respiratory rate (breaths per minute) in the first 30-days after hospital discharge
Measured: 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
Measured: 30-days after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start1 Mar 2023
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult ALLStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mater Misericordiae University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Health Service Executive, Ireland
- Responsible party
- Principal investigator, Pádraig Ó Scanaill, Mater Misericordiae University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05642988
- Sponsor's protocol ID
- 1/378/2207
- Status last verified
- Dec 2023
- First submitted
- 30 Nov 2022
- Last updated
- 22 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Data for patients will strictly follow the agreed Data Protection Agreement (DPA) put in place by the Mater Misericordiae University Hospital
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Wearable Technology in High-risk Surgical Patients in the Perioperative Period: a Feasibility Study
- ClinicalTrials.gov ID
- NCT05642988
- Acronym / sponsor ID
- 1/378/2207
- Conditions
- Adult ALL, Surgery, Anesthesia, Postoperative Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mater Misericordiae University HospitalUniversity, hospital or other
- Collaborators
- Health Service Executive, Ireland
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 8 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients being discharged from hospital following intra-abdominal or pelvic surgery | – | Device: LifeSignals 1AX BiosensorPatient 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients recovering from major intra-cavity abdominal surgery being discharged from the Mater Misericordiae University Hospital in Dublin, Ireland.
Key inclusion criteria (3 listed)
- Over 18 years of age
- Scheduled to undergo or recently undergone major intra-cavity abdominal surgery
- Able to give informed written consent to participate
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LifeSignals 1AX BiosensorBiosensor worn by patients for 30-days after intra-abdominal or pelvic surgery on discharge from hospital | Device | Adult patients being discharged from hospital following intra-abdominal or pelvic surgery |
Primary outcome
Compliance with wearable technology
Time frame: 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.
5 secondary outcomes
Unplanned hospital admission or GP visits
Time frame: 30-days after hospital discharge
Heart rate
Time frame: 30-days after hospital discharge
Temperature
Time frame: 30-days after hospital discharge
Respiratory Rate
Time frame: 30-days after hospital discharge
Quality of recovery score (QoR15)
Time frame: 30-days after hospital discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2023.
- Individual participant dataSharing planned: No. Data for patients will strictly follow the agreed Data Protection Agreement (DPA) put in place by the Mater Misericordiae University Hospital
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adult ALL and Surgery, run by Mater Misericordiae University Hospital at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance with wearable technology (time frame: 30-days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2023.