Continuous Connected Patient Care (CCPC), a Pilot Testing a Novel Device for Continuous Vitals Monitoring - Department of Anesthesia at PHC

NCT06638073 | Recruiting

• 1 other identifier: H24-00862
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Surgical Procedure, Unspecified; Intensive Care Units (ICUs)

Outcome Measures

Primary Outcomes (6)

• Collect patient and clinicians' feedback about the CCPC Platform

  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.

  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

  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

  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.

  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.

  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

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bridge Health Solutions: collaborator
• Providence Healthcare: collaborator
• Excelar: collaborator
• Cloud DX Inc.: collaborator
• Medtronic - MITG: lead

Study Sites (1)

Saint Pauls Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

RECRUITING

Central Study Contacts

Elise Huisman

CONTACT

+1 236-308-4876; elise.huisman@medtronic.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2024
• First Posted: October 15, 2024
• Study Start: March 13, 2025
• Primary Completion (Estimated): June 20, 2026
• Study Completion (Estimated): June 20, 2026
• Last Updated: March 12, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)