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

Not Applicable

• Conditions: Hypercapnia; Hypoxia
• Interventions: Other: Breathing a mixture of O2, N2 and CO2 and monitoring SpO2 on each finger

• Registration Number: NCT04771663
• Lead Sponsor: Czech Technical University in Prague

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2021-01-10
• Study First Submitted: 2021-02-22
• Study First Submitted QC: 2021-02-24
• Study First Posted: 2021-02-25
• Primary Completion: 2023-02-15
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-16
• Last Update Posted: 2023-03-17
• Study Completion: 2023-10-15

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Hypoxic and Hypercapnic	Breathing a mixture of O2, N2 and CO2 and monitoring SpO2 on each finger	In this phase, participants inhale the hypoxic and hypercapnic mixture for five minutes.
Hypoxic	Breathing a mixture of O2, N2 and CO2 and monitoring SpO2 on each finger	In this phase, participants inhale the hypoxic mixture for five minutes.

Primary Outcome Measures

Name	Time	Method
Does it depend on which finger is the sensor placed for SpO2 values?	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.

Trial Locations

Locations (1)

Czech Technical University in Prague; 🇨🇿 Kladno, Czechia