NCT05272943

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 10, 2022

Completed
1.5 years until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

July 27, 2023

Status Verified

July 1, 2023

Enrollment Period

4 months

First QC Date

February 17, 2022

Last Update Submit

July 26, 2023

Conditions

Oxygen Saturation Measurement

Keywords

pulse oximetrypediatric patientsmart phonesmart wearable

Outcome Measures

Primary Outcomes (1)

  • Pulse oximetry correlation

    Pulse oximetry correlation between the validated pulse oximetry and smart electronics

    Perioperatively

Secondary Outcomes (1)

  • Measurement tolerance

    Perioperatively

Study Arms (4)

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 oximetryOther: Oxgen saturation measurement 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 oximetryOther: Oxgen saturation measurement 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 oximetryOther: Oxgen saturation measurement 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 oximetryOther: Oxgen saturation measurement with smart electronics

Interventions

Oxgen saturation measurement with validated pulse oximetryOTHER

Oxgen saturation will be measured with validated pulse oximetry

General anesthesia measurementPACU measurementPICU measurementPreanesthesia visit measurement
Oxgen saturation measurement with smart electronicsOTHER

Oxgen saturation will be measured with smart electronics

General anesthesia measurementPACU measurementPICU measurementPreanesthesia visit measurement

Eligibility Criteria

Age1 Year - 19 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • outside age limits
  • refused to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brno University Hospital

Brno, South Moravian, 62500, Czechia

Location

Study Officials

  • Petr Stourac, prof. MD., Ph.D., MBA

    Department of paediatric anaesthesia and intensive care medicine

    STUDY CHAIR

Central Study Contacts

Jozef Klučka, assoc.prof.MD., Ph.D.

CONTACT

532234696klucka.jozef@fnbrno.cz

Petr Stourac, Prof.MD, Ph.D, MBA

CONTACT

532234696stourac.petr@fnbrno.cz

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

February 17, 2022

First Posted

March 10, 2022

Study Start

September 1, 2023

Primary Completion

December 30, 2023

Study Completion

December 30, 2023

Last Updated

July 27, 2023

Record last verified: 2023-07

Locations

CZ(1)