A study of a wireless sensor (the Radius VSM biosensor) during surgery and recovery

Clinical reliability, accuracy and applicability of continuous telemonitoring of vital parameters during the perioperative and early postoperative period using the Radius VSM biosensor: an observational study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN56757048

Enrollment

Registered

2024-07-26

Start date

2024-11-01

Completion date

Unknown

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients admitted at the surgical ward Surgery

Interventions

Patients receive standard care, and in addition will be wearing a wearable sensor for continuous monitoring of non-invasive blood pressure, heart rate, respiratory rate, temperature and oxygen saturat

Eligibility

Sex/Gender

All

Age

18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Patients admitted to the surgical ward 2. Planned for surgery 3. 18 years or older 4. Expected hospital stay of at least 48 hours

Exclusion criteria

Exclusion criteria: 1. Mentally incapable of participation 2. Unable to wear wearable devices 3. Postoperative ICU admission 4. No smartphone 5. Ambulatory or day surgery

Design outcomes

Primary

Measure	Time frame
Reliability and accuracy 1. Presence (percent of time) of a continuous data-stream of vital parameters via the Masimo Radius VSM device: heart rate, blood pressure, oxygen saturation, respiration rate and skin temperature 2. Comparison of the numerical values of the Masimo Radius VSM versus vital parameter measurements from perioperative anesthetic monitoring and postoperative monitoring at the PACU	—

Measure

Time frame

Reliability and accuracy 1. Presence (percent of time) of a continuous data-stream of vital parameters via the Masimo Radius VSM device: heart rate, blood pressure, oxygen saturation, respiration rate and skin temperature 2. Comparison of the numerical values of the Masimo Radius VSM versus vital parameter measurements from perioperative anesthetic monitoring and postoperative monitoring at the PACU

—

Secondary

Measure	Time frame
Clinical applicability 1. Data quality and data losses and how this is related to motion or physical activity 2. Vital parameters acquired during standard nursing rounds and MEWS data derived from rounds and computed by EMR 3. Patient reported pain scores and results from the daily QoR-15NL collected using RoQua (www.roqua.nl) and stored within the EMR 4. Incidence and moments of perioperative or postoperative complications 5. Incidence and moments of administration of (unexpected) drug therapy, e.g. i.v.-fluids, into tropics or antibiotics 6. Experiences of patients (satisfaction, barriers and potential benefits)	—

Measure

Time frame

Clinical applicability 1. Data quality and data losses and how this is related to motion or physical activity 2. Vital parameters acquired during standard nursing rounds and MEWS data derived from rounds and computed by EMR 3. Patient reported pain scores and results from the daily QoR-15NL collected using RoQua (www.roqua.nl) and stored within the EMR 4. Incidence and moments of perioperative or postoperative complications 5. Incidence and moments of administration of (unexpected) drug therapy, e.g. i.v.-fluids, into tropics or antibiotics 6. Experiences of patients (satisfaction, barriers and potential benefits)

—

Countries

Netherlands

Contacts

Public ContactMarjolein Haveman

m.e.haveman@umcg.nl-

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 7, 2026