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Variability of SpO2 Measurements Depending on the Choice of Finger for Sensor Placement (FinSpO2)

Primary Purpose

Hypoxia, Hypercapnia

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Breathing a mixture of O2, N2 and CO2 and monitoring SpO2 on each finger
Sponsored by
Czech Technical University in Prague
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hypoxia

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Czech Technical University in Prague

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Hypoxic

Hypoxic and Hypercapnic

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 22, 2021
Last Updated
March 16, 2023
Sponsor
Czech Technical University in Prague
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1. Study Identification

Unique Protocol Identification Number
NCT04771663
Brief Title
Variability of SpO2 Measurements Depending on the Choice of Finger for Sensor Placement
Acronym
FinSpO2
Official Title
Variability of SpO2 Measurements Depending on the Choice of Finger for Sensor Placement
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 10, 2021 (Actual)
Primary Completion Date
February 15, 2023 (Actual)
Study Completion Date
October 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Czech Technical University in Prague

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxia, Hypercapnia

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Interventional single blinded randomized crossover prospective study
Masking
Participant
Masking Description
The participant undergoes two phases of the experiment and the participant does not know which one
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hypoxic
Arm Type
Experimental
Arm Description
In this phase, participants inhale the hypoxic mixture for five minutes.
Arm Title
Hypoxic and Hypercapnic
Arm Type
Experimental
Arm Description
In this phase, participants inhale the hypoxic and hypercapnic mixture for five minutes.
Intervention Type
Other
Intervention Name(s)
Breathing a mixture of O2, N2 and CO2 and monitoring SpO2 on each finger
Intervention Description
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.
Primary Outcome Measure Information:
Title
Does it depend on which finger is the sensor placed for SpO2 values?
Description
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.
Time Frame
Up to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karel Roubík
Organizational Affiliation
Czech Technical University in Prague, FBMI
Official's Role
Study Director
Facility Information:
Facility Name
Czech Technical University in Prague
City
Kladno
ZIP/Postal Code
27201
Country
Czechia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28802098
Citation
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.
Results Reference
background

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

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