SpO2 Difference Between Fingers of the Hand During Sequential Desaturation and Step Resaturation

Not Applicable

• Conditions: SpO2; Hypoxia; Pulse Oximetry
• Interventions: Other: Breathing mixtures of O2 and N2 and monitoring SpO2 on each finger

• Registration Number: NCT05681637
• Lead Sponsor: Czech Technical University in Prague

Brief 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).

Detailed 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.

Study Timeline

• Study First Submitted: 2022-12-10
• Study First Submitted QC: 2023-01-11
• Study First Posted: 2023-01-12
• Study Start: 2023-01-31
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-16
• Last Update Posted: 2023-03-17
• Primary Completion: 2023-05-20
• Study Completion: 2023-12-20

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: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hypoxia	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.

Primary Outcome Measures

Name	Time	Method
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.	1 hour	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.

Secondary Outcome Measures

Name	Time	Method
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.	1 hour	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.

Trial Locations

Locations (1)

Czech Technical University in Prague; 🇨🇿 Kladno, Czechia