Variability of SpO2 Measurements Depending on the Choice of Finger for Sensor Placement

Hypoxia Clinical Trial

— FinSpO2  

Official title:

Variability of SpO2 Measurements Depending on the Choice of Finger for Sensor Placement

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04771663
• Other study ID #: CzechTU
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 10, 2021
• Est. completion date: October 15, 2023

Study information

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

Clinical Trial Summary

The aim of the project is to experimentally determine the effect of the choice of finger for the placement of a pulse oximeter sensor on the results of measuring peripheral blood oxygen saturation (SpO2) in a healthy person with short-term hypoxia and hypercapnia.

Description:

The aim of the project is to experimentally determine the effect of the choice of finger for the placement of a pulse oximeter sensor on the results of measuring peripheral blood oxygen saturation (SpO2) in a healthy person with short-term hypoxia and hypercapnia. This is an intervention prospective study that will take place at the Faculty of Biomedical Engineering, especially on FBMI students. The experiment consists of two phases, in which in the first phase, the volunteers will inhale the hypoxic mixture for five minutes after the stabilization phase. In the second phase, volunteers inhale a hypoxic and hypercapnic mixture. During the experiment, non-invasive SpO2 measurements will be performed continuously on individual fingers of both volunteer hands.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: October 15, 2023
• Est. primary completion date: February 15, 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.

Related Conditions & MeSH terms

• Hypercapnia
• Hypoxia

Intervention

Other:
• Breathing a mixture of O2, N2 and CO2 and monitoring SpO2 on each finger
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.

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	Does it depend on which finger is the sensor placed for SpO2 values?	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