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

NCT04771663 | Completed

• 1 other identifier: CzechTU
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoxia; Hypercapnia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Hypoxic

EXPERIMENTAL

In this phase, participants inhale the hypoxic mixture for five minutes.

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

Hypoxic and Hypercapnic

EXPERIMENTAL

In this phase, participants inhale the hypoxic and hypercapnic mixture for five minutes.

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

Interventions

Breathing a mixture of O2, N2 and CO2 and monitoring SpO2 on each finger OTHER

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.

Hypoxic; Hypoxic and Hypercapnic

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Passing the initial examination, which will determine the following data: finger circumference, heart rate, blood pressure and blood oxygen saturation

You may not qualify if:

• 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.

Sponsors & Collaborators

• Czech Technical University in Prague: lead

Study Sites (1)

Czech Technical University in Prague

Kladno, 27201, Czechia

Location

Related 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.

  PMID: 28802098 BACKGROUND

MeSH Terms

Conditions

Hypoxia; Hypercapnia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Karel Roubík

  Czech Technical University in Prague, FBMI

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participant undergoes two phases of the experiment and the participant does not know which one
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Interventional single blinded randomized crossover prospective study

Study Record Dates

• First Submitted: February 22, 2021
• First Posted: February 25, 2021
• Study Start: November 5, 2020
• Primary Completion: February 15, 2021
• Study Completion: October 15, 2025
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)