search
Back to results

SpO2 Difference Between Fingers of the Hand During Sequential Desaturation and Step Resaturation (StatDynSpO2)

Primary Purpose

Hypoxia, Pulse Oximetry, SpO2

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Breathing mixtures of O2 and N2 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 Type

Experimental

Arm Label

Hypoxia

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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

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.
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.

Full Information

First Posted
December 10, 2022
Last Updated
March 16, 2023
Sponsor
Czech Technical University in Prague
search

1. Study Identification

Unique Protocol Identification Number
NCT05681637
Brief Title
SpO2 Difference Between Fingers of the Hand During Sequential Desaturation and Step Resaturation
Acronym
StatDynSpO2
Official Title
SpO2 Difference Between Fingers of the Hand During Sequential Desaturation and Step Resaturation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 31, 2023 (Actual)
Primary Completion Date
May 20, 2023 (Anticipated)
Study Completion Date
December 20, 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxia, Pulse Oximetry, SpO2

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Interventional prospective study
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hypoxia
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Breathing mixtures of O2 and N2 and monitoring SpO2 on each finger
Intervention Description
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 Measure Information:
Title
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.
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
1 hour
Secondary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
1 hour

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 Roubik, Professor
Organizational Affiliation
Czech Technical University
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

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

Learn more about this trial

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

We'll reach out to this number within 24 hrs