Oxygen Saturation Measurement With Pulse Oximetry and With Smart Phones and Smart Wearable (SATURATE)

July 26, 2023 updated by: Petr Štourač, MD, Brno University Hospital

Oxygen Saturation Measurement With Pulse Oximetry and Smart Phones and Smart Wearable: Prospective Observational Trial

Oxgen saturation measurement with the pulse oximetry is considered as a standard of care for respiratory system monitoring. The evaluation of measured oxygen saturation could lead to the clinical decision making in taking care of patient with respiratory failure. Smart electronics (such smart phones, smart watch, and others) are currently equipped with the sensors and applications that allows the peripheral oxygen saturation, however the corelation between the validated measurement (pulse oximetry) and smart electronics measurement is not known at the moment. In case of close correlation and high sensitivity, could be the smart electronics used for oxygenation evaluation of outpatients together with possible early deterioration detection.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

After informed consent from patients and/or legal guardian the oxygen saturation will be measured by calibrated pulse oxymetry (validated for medical use only) and by smart electronics (smart phones and smart wearable) in pediatric patients during the preanesthesia evaluation, under general anesthesia, during the postanesthesia care unit (PACU) stay, and at pediatric intensive care unit (PICU) stay. In one patient, overall 6 measurements in will be performed (3 on right and 3 on left hand).

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Czechia
    • South Moravian Region
      • Brno, South Moravian Region, Czechia, 62500
        • Brno University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 19 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Pediatric patients during during preanesthesia visit, general anesthesia, PACU and PICU stay will be eligible for inclusion

Description

Inclusion Criteria:

  • Informed consent
  • pediatric patients during preanesthesia visit
  • pediatric patients during general anesthesia
  • pediatric patients during PACU stay
  • pediatric patients during PICU stay

Exclusion Criteria:

  • outside age limits
  • refused to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Preanesthesia visit measurement
Oxygen saturation will be measured by validated pulse oxymetry and smart electronics in pediatric patients during preanesthesia visit
Other: Oxgen saturation measurement with validated pulse oximetry
Oxgen saturation will be measured with validated pulse oximetry
Other: Oxgen saturation measurement with smart electronics
Oxgen saturation will be measured with smart electronics
General anesthesia measurement
Oxygen saturation will be measured by validated pulse oxymetry and smart electronics in pediatric patients during general anesthesia
Other: Oxgen saturation measurement with validated pulse oximetry
Oxgen saturation will be measured with validated pulse oximetry
Other: Oxgen saturation measurement with smart electronics
Oxgen saturation will be measured with smart electronics
PACU measurement
Oxygen saturation will be measured by validated pulse oxymetry and smart electronics in pediatric patients during PACU stay
Other: Oxgen saturation measurement with validated pulse oximetry
Oxgen saturation will be measured with validated pulse oximetry
Other: Oxgen saturation measurement with smart electronics
Oxgen saturation will be measured with smart electronics
PICU measurement
Oxygen saturation will be measured by validated pulse oxymetry and smart electronics in pediatric patients during PICU stay
Other: Oxgen saturation measurement with validated pulse oximetry
Oxgen saturation will be measured with validated pulse oximetry
Other: Oxgen saturation measurement with smart electronics
Oxgen saturation will be measured with smart electronics

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pulse oximetry correlation
Time Frame: Perioperatively
Pulse oximetry correlation between the validated pulse oximetry and smart electronics
Perioperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement tolerance
Time Frame: Perioperatively
The tolerance of measurement will be evaluated by number of valid measurement attempts
Perioperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brno University Hospital

Collaborators

Masaryk University

Investigators

  • Study Chair: Petr Stourac, prof. MD., Ph.D., MBA, Department of paediatric anaesthesia and intensive care medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2023

Primary Completion (Estimated)

December 30, 2023

Study Completion (Estimated)

December 30, 2023

Study Registration Dates

First Submitted

February 17, 2022

First Submitted That Met QC Criteria

March 8, 2022

First Posted (Actual)

March 10, 2022

Study Record Updates

Last Update Posted (Actual)

July 27, 2023

Last Update Submitted That Met QC Criteria

July 26, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KDAR SATURATE 2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Oxygen Saturation Measurement

Clinical Trials on Oxgen saturation measurement with validated pulse oximetry

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Georgia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe