Oxygen Saturation MeasurementSATURATENCT05272943
Oxygen Saturation Measurement With Pulse Oximetry and With Smart Phones and Smart Wearable
An observational study of Oxygen Saturation Measurement, run by Brno University Hospital at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 19 years
- Conditions the study is for
- Oxygen Saturation Measurement
- What is being tested?
- Oxgen saturation measurement with validated pulse oximetry and Oxgen saturation measurement with smart electronics
- How many people
- 120 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Sep 2023to 30 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 19 years
- All sexes
- Child, Adult
Study population: Pediatric patients during during preanesthesia visit, general anesthesia, PACU and PICU stay will be eligible for inclusion
Who may be able to join
- Informed consent
- pediatric patients during preanesthesia visit
- pediatric patients during general anesthesia
- pediatric patients during PACU stay
- pediatric patients during PICU stay
Who cannot join
- outside age limits
- refused to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Oxygen Saturation Measurement
- Being tested
- Oxgen saturation measurement with validated pulse oximetry, Oxgen saturation measurement with smart electronics
- Keywords
- pulse oximetry, pediatric patient, smart phone, smart wearable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxgen saturation measurement with validated pulse oximetryOther
Oxgen saturation will be measured with validated pulse oximetry
Oxgen saturation measurement with smart electronicsOther
Oxgen saturation will be measured with smart electronics
| Study group | Role | What they receive |
|---|---|---|
| Preanesthesia visit measurement | Oxygen saturation will be measured by validated pulse oxymetry and smart electronics in pediatric patients during preanesthesia visit Receives: Other: Oxgen saturation measurement with validated pulse oximetry; Other: 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 Receives: Other: Oxgen saturation measurement with validated pulse oximetry; Other: 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 Receives: Other: Oxgen saturation measurement with validated pulse oximetry; Other: 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 Receives: Other: Oxgen saturation measurement with validated pulse oximetry; Other: Oxgen saturation measurement with smart electronics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulse oximetry correlation
Pulse oximetry correlation between the validated pulse oximetry and smart electronics
Measured: Perioperatively
Secondary outcomes (1)
Measurement tolerance
The tolerance of measurement will be evaluated by number of valid measurement attempts
Measured: Perioperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2022
- Study start1 Sep 2023 (estimated)
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxygen Saturation MeasurementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brno University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Masaryk University
- Responsible party
- Principal investigator, Petr Štourač, MD, Brno University Hospital
- Investigators
- Petr Stourac, prof. MD., Ph.D., MBA, Study chair, Department of paediatric anaesthesia and intensive care medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05272943
- Sponsor's protocol ID
- KDAR SATURATE 2022
- Acronym
- SATURATE
- Status last verified
- Jul 2023
- First submitted
- 17 Feb 2022
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxygen Saturation Measurement With Pulse Oximetry and Smart Phones and Smart Wearable: Prospective Observational Trial
- ClinicalTrials.gov ID
- NCT05272943
- Acronym / sponsor ID
- SATURATE / KDAR SATURATE 2022
- Conditions
- Oxygen Saturation Measurement
- Keywords
- pulse oximetry, pediatric patient, smart phone, smart wearable
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Brno University HospitalUniversity, hospital or other
- Collaborators
- Masaryk University
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 10 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Preanesthesia visit measurement | – | Other: Oxgen saturation measurement with validated pulse oximetry, Other: Oxgen saturation measurement with smart electronicsOxygen saturation will be measured by validated pulse oxymetry and smart electronics in pediatric patients during preanesthesia visit |
| General anesthesia measurement | – | Other: Oxgen saturation measurement with validated pulse oximetry, Other: Oxgen saturation measurement with smart electronicsOxygen saturation will be measured by validated pulse oxymetry and smart electronics in pediatric patients during general anesthesia |
| PACU measurement | – | Other: Oxgen saturation measurement with validated pulse oximetry, Other: Oxgen saturation measurement with smart electronicsOxygen saturation will be measured by validated pulse oxymetry and smart electronics in pediatric patients during PACU stay |
| PICU measurement | – | Other: Oxgen saturation measurement with validated pulse oximetry, Other: Oxgen saturation measurement with smart electronicsOxygen saturation will be measured by validated pulse oxymetry and smart electronics in pediatric patients during PICU stay |
Who may qualify
- Ages
- 1 year to 19 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Pediatric patients during during preanesthesia visit, general anesthesia, PACU and PICU stay will be eligible for inclusion
Key inclusion criteria (5 listed)
- Informed consent
- pediatric patients during preanesthesia visit
- pediatric patients during general anesthesia
- pediatric patients during PACU stay
- pediatric patients during PICU stay
Key exclusion criteria (2 listed)
- outside age limits
- refused to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxgen saturation measurement with validated pulse oximetryOxgen saturation will be measured with validated pulse oximetry | Other | General anesthesia measurement, PACU measurement, PICU measurement, Preanesthesia visit measurement |
| Oxgen saturation measurement with smart electronicsOxgen saturation will be measured with smart electronics | Other | General anesthesia measurement, PACU measurement, PICU measurement, Preanesthesia visit measurement |
Primary outcome
Pulse oximetry correlation
Time frame: Perioperatively
Pulse oximetry correlation between the validated pulse oximetry and smart electronics
1 secondary outcome
Measurement tolerance
Time frame: Perioperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Petr Stourac, prof. MD., Ph.D., MBA study chair
Department of paediatric anaesthesia and intensive care medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oxygen Saturation Measurement, run by Brno University Hospital at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jozef Klučka, assoc.prof.MD., Ph.D. (532234696, klucka.jozef@fnbrno.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulse oximetry correlation (time frame: Perioperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.