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
- 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 orgaansysteemNot applicable
- Registration Number
- NL-OMON53891
- Lead Sponsor
- Fastfocus BV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 20
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
• 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
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcomes are oxygen saturation, pulse rate, and respiratory rate.<br /><br>This is a methods comparison study with clinically used reference devices. The<br /><br>primary outcome is the accuracy of blood oxygen saturation, pulse rate, and<br /><br>respiratory rate. The minimal accuracy level should be <= ±4% in the range of<br /><br>70-100% for SpO2 according to international standards [5].</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary outcome is patient comfort and experience.<br /><br>Another secondary outcome is pulse oximetry are Spo2 levels as mean difference<br /><br>(bias) is within ± 2% of the reference standard.</p><br>