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

Not yet recruiting

• Conditions: Oxygen Saturation Measurement
• Interventions: Other: Oxgen saturation measurement with validated pulse oximetry; Other: Oxgen saturation measurement with smart electronics

• Registration Number: NCT05272943
• Lead Sponsor: Brno University Hospital

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.

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 Timeline

• Study First Submitted: 2022-02-17
• Study First Submitted QC: 2022-03-08
• Study First Posted: 2022-03-10
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-26
• Last Update Posted: 2023-07-27
• Study Start: 2023-09-01
• Primary Completion: 2023-12-30
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Pulse oximetry correlation	Perioperatively	Pulse oximetry correlation between the validated pulse oximetry and smart electronics

Secondary Outcome Measures

Name	Time	Method
Measurement tolerance	Perioperatively	The tolerance of measurement will be evaluated by number of valid measurement attempts

Trial Locations

Locations (1)

Brno University Hospital; 🇨🇿 Brno, South Moravian Region, Czechia