SATURATE: Oxygen Saturation Measurement With Pulse Oximetry and With Smart Phones and Smart Wearable

Sponsor
Brno University Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05272943
Collaborator
Masaryk University (Other)
120
1
5
24.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Oxgen saturation measurement with validated pulse oximetry
  • Other: Oxgen saturation measurement with smart electronics

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 Design

Study Type:
Observational
Anticipated Enrollment :
120 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Oxygen Saturation Measurement With Pulse Oximetry and Smart Phones and Smart Wearable: Prospective Observational Trial
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Dec 30, 2022
Anticipated Study Completion Date :
Dec 30, 2022

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Pulse oximetry correlation [Perioperatively]

    Pulse oximetry correlation between the validated pulse oximetry and smart electronics

Secondary Outcome Measures

  1. Measurement tolerance [Perioperatively]

    The tolerance of measurement will be evaluated by number of valid measurement attempts

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Year to 19 Years
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Brno University Hospital Brno South Moravian Region Czechia 62500

Sponsors and Collaborators

  • Brno University Hospital
  • Masaryk University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Petr Štourač, MD, Clinical Professor, Brno University Hospital
ClinicalTrials.gov Identifier:
NCT05272943
Other Study ID Numbers:
  • KDAR SATURATE 2022
First Posted:
Mar 10, 2022
Last Update Posted:
Jul 19, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Petr Štourač, MD, Clinical Professor, Brno University Hospital

Study Results

No Results Posted as of Jul 19, 2022