- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06638073
Continuous Connected Patient Care (CCPC), a Pilot Testing a Novel Device for Continuous Vitals Monitoring - Department of Anesthesia at PHC
March 10, 2026 updated by: Medtronic - MITG
To confirm feasibility and accessibility of the CCPC Platform (Oxymotion, Bridge Health Solutions medication adherence software, CloudDX home kit) in two different environments - in hospital and at-home, in patients undergoing non-cardiac surgery.
Study Overview
Status
Recruiting
Study Type
Observational
Enrollment (Estimated)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Elise Huisman
- Phone Number: +1 236-308-4876
- Email: elise.huisman@medtronic.com
Study Locations
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V6Z 1Y6
- Recruiting
- Saint Pauls Hospital
-
Contact:
- Ronald Ree, MD
- Email: rree@providencehealth.bc.ca
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Patients that have undergone a non-cardiac surgery requiring an inpatient hospital stay and peri-op patients who are in the Surgical High Acuity Unit (SHAU) at SPH.
Description
Inclusion Criteria:
- 19 years or older
- Patients that have undergone a non-cardiac surgery at SPH requiring an inpatient hospital stay
- Peri-op patients who are in the Surgical High Acuity Unit (SHAU) and those followed by Anesthesia Perioperative Outreach team on the ward
- Living within British Columbia, Canada and in an area that is covered by Bell cellular network
Exclusion Criteria:
- Patient refusal
- Lack of capacity to consent to the study (including having received sedative or general anesthetic within the past 24 hours)
- Unable to use (or does not have a caregiver who can help put on) study monitoring device at home
- Unable to complete (or does not have a caregiver who can help complete) study questionnaires by electronic (mobile, tablet, or computer), paper, nor phone
- No access to cell phone nor landline at home to receive follow-ups
- Preoperatively known to be discharged to a nursing home or rehabilitation facility
- Known allergic reactions to any part material of study devices
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Collect patient and clinicians' feedback about the CCPC Platform
Time Frame: From enrollment to the end of follow up at 10 days
|
This will be completed via an assessment of the quantitative data on how long and how often patients use this monitoring and what were the reasons that patients took the monitors on and off.
|
From enrollment to the end of follow up at 10 days
|
|
Confirm the technical goals of the CCPC platform are met.
Time Frame: From enrollment to the end of follow up at 10 days
|
This will be completed by ensuring clinical workflow is met when using the monitoring platform.
|
From enrollment to the end of follow up at 10 days
|
|
Collect patient and clinicians' feedback about the CCPC Platform
Time Frame: From enrollment to the end of follow up at 10 days
|
This will be completed via an assessment of the Usability questionnaires.
|
From enrollment to the end of follow up at 10 days
|
|
Collect patient and clinicians' feedback about the CCPC Platform
Time Frame: From enrollment to the end of follow up at 10 days
|
This will be completed by an evaluation of potential harm, adverse events and safety issues.
|
From enrollment to the end of follow up at 10 days
|
|
Confirm the technical goals of the CCPC platform are met.
Time Frame: From enrollment to the end of follow up at 10 days
|
This will be completed via an assessment of the data flow: does the correct patient vitals information reach the clinicians at the right time?
|
From enrollment to the end of follow up at 10 days
|
|
Confirm the technical goals of the CCPC platform are met.
Time Frame: From enrollment to the end of follow up at 10 days
|
This will be completed by determining if the CCPC platform provided a holistic view of each patient with vitals, medication, and other collected data.
|
From enrollment to the end of follow up at 10 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 13, 2025
Primary Completion (Estimated)
June 20, 2026
Study Completion (Estimated)
June 20, 2026
Study Registration Dates
First Submitted
September 16, 2024
First Submitted That Met QC Criteria
October 9, 2024
First Posted (Actual)
October 15, 2024
Study Record Updates
Last Update Posted (Actual)
March 12, 2026
Last Update Submitted That Met QC Criteria
March 10, 2026
Last Verified
May 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- H24-00862
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.