Variability of SpO2 Measurements Depending on the Choice of Finger for Sensor Placement (FinSpO2)
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Kladno, Czechia, 27201
- Czech Technical University in Prague
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Passing the initial examination, which will determine the following data: finger circumference, heart rate, blood pressure and blood oxygen saturation
Exclusion Criteria:
- post-traumatic conditions of the upper limbs affecting the perfusion of the fingers or injuries or skin diseases on the fingers.
- pneumothorax or a condition after cardiovascular surgery.
- anemia, bradycardia, hemoglobinopathy or other diseases of the cardiovascular system, pregnancy, diabetes, hypotension or hypertension.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Hypoxic
In this phase, participants inhale the hypoxic mixture for five minutes.
|
The experiment consists of two separate phases.
In one phase, the volunteers inhale one of the mixtures for five minutes.
After enough time of recovery, the volunteers undergo the other phase in which they inhale the other mixture of gases.
Both phases of the measurement will begin with a two-minute stabilization phase, during which the physiological values of the volunteer will be checked.
During the experiment, non-invasive SpO2 measurements will be performed continuously on the individual fingers of both volunteer hands throughout the experiment.
|
|
Experimental: Hypoxic and Hypercapnic
In this phase, participants inhale the hypoxic and hypercapnic mixture for five minutes.
|
The experiment consists of two separate phases.
In one phase, the volunteers inhale one of the mixtures for five minutes.
After enough time of recovery, the volunteers undergo the other phase in which they inhale the other mixture of gases.
Both phases of the measurement will begin with a two-minute stabilization phase, during which the physiological values of the volunteer will be checked.
During the experiment, non-invasive SpO2 measurements will be performed continuously on the individual fingers of both volunteer hands throughout the experiment.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Does it depend on which finger is the sensor placed for SpO2 values?
Time Frame: Up to 12 weeks
|
The experiment can help determine if it depends on which finger the finger sensor will be placed to measure SpO2.
Appropriate finger selection for SpO2 measurements could help to better interpret the measured values and possibly increase the success in diagnosing health events.
|
Up to 12 weeks
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Study Director: Karel Roubík, Czech Technical University in Prague, FBMI
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- CzechTU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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