Clinical Validation of a Novel, Accelerometer Based, Continuous Respiratory Rate Sensor

Not Applicable

Not yet recruiting

• Conditions: Respiratory Rate Accuracy Test; Capnography; Wireless Vital Signs Monitoring System; Respiratory Rate

• Registration Number: NCT06911541
• Lead Sponsor: Haraldsplass Deaconess Hospital

Brief Summary

Comparing a wireless accelerometer-based sensor that continuously measure breathing rate with the gold standard capnography. The aim is to evaluate if both methods are equivalent.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-13
• Status Verified: 2025-03
• Study First Submitted QC: 2025-04-03
• Last Update Submitted: 2025-04-03
• Study First Posted: 2025-04-04
• Last Update Posted: 2025-04-04
• Study Start: 2025-05
• Primary Completion: 2025-05
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Admitted to the Hospital
• Expected to remain undisturbed for at least one hour

Exclusion Criteria

• Not able to give informed consent
• Use of high flow oxygen therapy
• Skin disease preventing proper attachment of the sensor
• Implanted electronic medical device.
• Known infection or colonisation with microbes necessitating protective measures above routine care

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Validation of correctness of the sensor	one hour	The respiratory rate measured by the sensor is being compared to the respiratory rate by capnography. A discrepancy of +- 3 breaths/min is within the acceptable range.

Trial Locations

Locations (1)

Haraldsplass Deaconess Hospital; 🇳🇴 Bergen, Norway