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

NCT05681637 | Unknown

• 1 other identifier: NVT01/2022
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Hypoxia; Pulse Oximetry; SpO2

Outcome Measures

Primary Outcomes (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.

  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.

  1 hour

Secondary Outcomes (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

Study Arms (1)

Hypoxia

EXPERIMENTAL

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

Interventions

Breathing mixtures of O2 and N2 and monitoring SpO2 on each finger OTHER

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.

Hypoxia

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

Condition Hierarchy (Ancestors)

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

Study Officials

• Karel Roubik, Professor

  Czech Technical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Interventional prospective study

Study Record Dates

• First Submitted: December 10, 2022
• First Posted: January 12, 2023
• Study Start: January 31, 2023
• Primary Completion: May 20, 2023
• Study Completion: December 20, 2023
• Last Updated: March 17, 2023

Record last verified: 2023-03

Locations

CZ (1)