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

Sponsor
Czech Technical University in Prague (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05681637
Collaborator
(none)
40
1
1
10.6
3.8

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Other: Breathing mixtures of O2 and N2 and monitoring SpO2 on each finger
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Interventional prospective studyInterventional prospective study
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
SpO2 Difference Between Fingers of the Hand During Sequential Desaturation and Step Resaturation
Anticipated Study Start Date :
Jan 31, 2023
Anticipated Primary Completion Date :
May 20, 2023
Anticipated Study Completion Date :
Dec 20, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Hypoxia

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.

Other: 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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Czech Technical University in Prague Kladno Czechia 27201

Sponsors and Collaborators

  • Czech Technical University in Prague

Investigators

  • Study Director: Karel Roubik, Professor, Czech Technical University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Czech Technical University in Prague
ClinicalTrials.gov Identifier:
NCT05681637
Other Study ID Numbers:
  • NVT01/2022
First Posted:
Jan 12, 2023
Last Update Posted:
Jan 12, 2023
Last Verified:
Jan 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 12, 2023