Clinical validation study of a wireless and wearable sensor for continuous vital signs monitoring in a clinical setting with vital sign ranges limited to the parameters recorded in a post anesthesia care unit

Clinical validation study of a wireless and wearable sensor for continuous vital signs monitoring in a clinical setting with vital sign ranges limited to the parameters recorded in a post anesthesia care unit - Clinical performance of a new wearable vital signs monitoring device

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON53891

Enrollment

Registered

2023-09-13

Start date

2024-01-17

Completion date

Unknown

Last updated

2026-06-15

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

Conditions

Dit betreft een observationele studie met continue metingen van vitale functies bij patiënten met risico op adverse events, welke niet gerelateerd is aan een enkele aandoening of orgaansysteem Not applicable

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Adult patients (>18 years) (all sexes) • Surgical admission to hospital • At risk for transient perioperative desaturation (intermediate and major surgery) • Minimum expected duration at the recovery: at least 12 hours (excluding day case surgery)

Exclusion criteria

Exclusion criteria: • Inability to give informed consent. • Planned primary post-operative admission to the Intensive Care Unit • Surgical location on - or close - to the ear • Patients with any of the contraindications (see section 4.3.1 of protocol pagina 13) • Pregnant or breastfeeding women

Design outcomes

Primary

Measure	Time frame
The primary outcomes are oxygen saturation, pulse rate, and respiratory rate. This is a methods comparison study with clinically used reference devices. The primary outcome is the accuracy of blood oxygen saturation, pulse rate, and respiratory rate. The minimal accuracy level should be	—

Secondary

Measure	Time frame
The secondary outcome is patient comfort and experience. Another secondary outcome is pulse oximetry are Spo2 levels as mean difference (bias) is within ± 2% of the reference standard.	—

Countries

Netherlands

Outcome results