Pulse Oximetry Performance Test for PaMo - Controlled Desaturation Test

NCT07676227 | Completed DMC

• 1 other identifier: PamoSpO2
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to gather measurement data for the development and testing of a wearable patient monitor's pulse oximeter. The PaMo patient monitor measures respiratory rate, blood oxygen saturation, and electrocardiogram (ECG). The device transmits data via Bluetooth to a mobile application for immediate interpretation. The device, developed at Tampere University, aims to provide a wireless solution for monitoring patients' breathing and circulation, especially after surgical procedures. The collected data will be used to demonstrate the device's oxygen saturation measurement capability according to the European ISO 80601-2-61:2019 standard, contributing to further refinement of the solution.

Conditions

Vital Sign Monitoring; Vital Signs

Keywords

pulse oximetry; vital sign monitoring; controlled desaturation; ISO 80601-2-61:2019

Outcome Measures

Primary Outcomes (1)

• Blood Oxygen Saturation Accuracy

  Average root mean square (ARMS) difference compared with reference device

  Continuous measurement up to 30 minutes

Secondary Outcomes (1)

• Hypoxia Detection

  Continuous measurement up to 30 minutes

Study Arms (1)

Controlled desaturation for healthy volunteers

EXPERIMENTAL

Device: Hypoxia, intermittent

Interventions

Hypoxia, intermittent DEVICE

Controlled hypoxia induced with Hypoxico device

Controlled desaturation for healthy volunteers

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age: minimum of 18 years and max 40 years
• ASA category 1
• positive Allen's test
• Passing the physical examination
• Ability to give informed consent
• Volunteering to the study

You may not qualify if:

• Age under 18 or over 40 years
• Smoker
• Pregnancy
• Does not pass the physical examination
• Negative Allen's test
• Relevant medical illnesses
• Cardiovascular disease
• Pulmonary disease
• Insufficient knowledge in Finnish or English
• Cardiac pacemaker
• Inability to give informed consent
• Denial

Sponsors & Collaborators

• Tampere University: lead

Study Sites (1)

Tampere University

Tampere, Finland

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 15, 2026
• First Posted: June 30, 2026
• Study Start: January 19, 2024
• Primary Completion: June 10, 2024
• Study Completion: December 31, 2025
• Last Updated: June 30, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)