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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05681637
Other study ID # NVT01/2022
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date January 31, 2023
Est. completion date December 20, 2023

Study information

Verified date March 2023
Source Czech Technical University in Prague
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of the project is to experimentally compare the fingers of the hand in terms of measured concentrations of peripheral blood oxygen saturation (SpO2) in healthy humans during gradual desaturation in the range of 60-100% SpO2 and simultaneously during a step change from the hypoxic phase to the recovery phase (return to physiological values).


Description:

The finger sensors of pulse oximeters are most often placed on the middle two fingers of the hand. Although there have been many studies looking at the accuracy of different pulse oximeters or comparing fingers in terms of SpO2. There is no study comparing fingers in terms of SpO2 under hypoxic condition with simultaneous randomization of finger probe placement. At the same time, there is no study that compares SpO2 changes between fingers during a step change in blood oxygen saturation. The data obtained could help to improve the reliability of monitoring physiological parameters with pulse oximeters.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 40
Est. completion date December 20, 2023
Est. primary completion date May 20, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Breathing mixtures of O2 and N2 and monitoring SpO2 on each finger
Volunteers sequentially inhale three hypoxic gas mixtures each for 2.5 minute. Every 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 volunteer hands throughout the experiment.

Locations

Country Name City State
Czechia Czech Technical University in Prague Kladno

Sponsors (1)

Lead Sponsor Collaborator
Czech Technical University in Prague

Country where clinical trial is conducted

Czechia, 

References & Publications (1)

Rafl J, Kulhanek F, Kudrna P, Ort V, Roubik K. Response time of indirectly accessed gas exchange depends on measurement method. Biomed Tech (Berl). 2018 Nov 27;63(6):647-655. doi: 10.1515/bmt-2017-0070. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Non-invasive SpO2 measurements will be performed continuously on all individual fingers of left hand of volunteers and then the measured values will be compared between each other. 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. 1 hour
Secondary Non-invasive Perfusion Index measurements will be performed continuously on all individual fingers of left hand of volunteers and then the measured values will be compared between each other. The experiment can help determine if it depends on which finger the finger sensor will be placed to measure perfusion index. Measurement of PI is evaluated during for example surgeries. 1 hour
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