Clinical Trials Logo
  1. Home
  2. Hypoxia
  3. NCT05657288
  4. Details
NCT05657288 Clinical Trial

SpO2 Comparison Between Commercial Smartwatch and Medical-grade Pulse Oximeter During Hypoxia

Hypoxia Clinical Trial

— HYPOWATCH  

Official title:
SpO2 Comparison Between Commercial Smartwatch and Medical-grade Pulse Oximeter

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT05657288
Other study ID # NVT02/2022
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date December 28, 2022
Est. completion date December 20, 2023

Study information
Verified date March 2023
Source Czech Technical University in Prague
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of the project is to experimentally compare SpO2 measured on a wrist by commercial Smartwach and on a finger measured by a medical-grade pulse oximeter in healthy humans during gradual desaturation in the range of 60-100% SpO2 and simultaneously during a step change from the hypoxic phase to the recovery phase (return to physiological values).

Description:

The newest models of smartwatches measure peripheral blood oxygen saturation (SpO2) and the technology is rapidly improving. The results of individual studies on the accuracy of SpO2 measurement using smartwatches from different brands are still inconclusive. The study aims to compare the measurement of peripheral blood oxygen saturation using the latest smartwatch with a medical-grade pulse oximeter under the condition of normobaric hypoxia. SpO2 measurements will be taken by hand from the watch and the pulse oximeter simultaneously. The agreement of the measurements of both devices will be evaluated.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 40
Est. completion date December 20, 2023
Est. primary completion date May 20, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - Passing the initial examination, which will determine the following data: finger circumference, heart rate, blood pressure, blood oxygen saturation and medical history Exclusion Criteria: - pregnancy - severe cardiovascular conditions - severe asthma or other severe respiratory conditions - injury to the upper limbs or hands that could affect the peripheral perfusion - diabetes - hypotension or hypertension

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Breathing mixtures of O2 and N2 and monitoring SpO2 on finger and left wrist
Volunteers sequentially inhale three hypoxic gas mixtures each for 2.5 minute. Every measurement will begin with a two-minute stabilization phase, during which the physiological values of the volunteer will be checked. During the whole experiment, non-invasive SpO2 measurements will be performed on the middle finger and on the wrist of left hand.

Locations
Country Name City State
Czechia Czech Technical University in Prague Kladno

Sponsors (1)
Lead Sponsor Collaborator
Czech Technical University in Prague

Country where clinical trial is conducted

Czechia, 

References & Publications (1)

Rafl J, Bachman TE, Rafl-Huttova V, Walzel S, Rozanek M. Commercial smartwatch with pulse oximeter detects short-time hypoxemia as well as standard medical-grade device: Validation study. Digit Health. 2022 Oct 11;8:20552076221132127. doi: 10.1177/20552076221132127. eCollection 2022 Jan-Dec. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Is there any difference in measured SpO2 between finger and wrist during induced hypoxia? The agreement of SpO2 measurements of both monitoring devices will be evaluated. 1 hour
See also
  Status Clinical Trial Phase
Recruiting NCT04498598 - Structural Modification In Supraglottic Airway Device N/A
Completed NCT05532670 - N600X Low Saturation Accuracy Validation
Enrolling by invitation NCT04106401 - Intravascular Volumes in Hypoxia During Antarctic Confinement N/A
Recruiting NCT05883137 - High-flow Nasal Oxygenation for Apnoeic Oxygenation During Intubation of the Critically Ill
Not yet recruiting NCT05817448 - Hypoxia-induced Autophagy in the Pathogenesis of MAP
Recruiting NCT02661152 - DAHANCA 30: A Randomized Non-inferiority Trial of Hypoxia-profile Guided Hypoxic Modification of Radiotherapy of HNSCC. Phase 3
Terminated NCT02801162 - Evaluation of Accuracy and Precision of a New Arterial Blood Gas Analysis System Blood in Comparison With the Reference Standard N/A
Completed NCT02943863 - Regional Ventilation During High Flow Nasal Cannula and Conventional Nasal Cannula in Patients With Hypoxia N/A
Not yet recruiting NCT02201875 - Intrinsic Periodic Pattern of Breathing N/A
Completed NCT02105298 - Effect of Volume and Type of Fluid on Postoperative Incidence of Respiratory Complications and Outcome (CRC-Study) N/A
Completed NCT01922401 - Inverse Ratio Ventilation on Bariatric Operation N/A
Active, not recruiting NCT01681238 - Goal-directed Therapy in High-risk Surgery N/A
Completed NCT01463527 - Using Capnography to Reduce Hypoxia During Pediatric Sedation N/A
Completed NCT01507623 - Value of Capnography During Nurse Administered Propofol Sedation (NAPS) N/A
Withdrawn NCT00638040 - The Gene Expression Studies of the Role of Tumor Microenvironments in Tumor Progression N/A
Active, not recruiting NCT06097754 - Intermittent Exogenous Ketosis (IEK) at High Altitude N/A
Completed NCT04589923 - The VISION-Acute Study
Completed NCT05044585 - Evaluation of RDS MultiSense® in Desaturation Analysis in Healthy Volunteers N/A
Completed NCT03659513 - The Effect of ECMO on the Pharmacokinetics of the Drugs and Their Clinical Efficacy
Completed NCT03221387 - Sleep and Daytime Use of Humidified Nasal High-flow Oxygen in COPD Outpatients N/A