Plethysmography Curve Variability Depending on the Breath Cycle

Sponsor
Czech Technical University in Prague (Other)
Overall Status
Recruiting
CT.gov ID
NCT05302219
Collaborator
(none)
20
1
1
3.7
5.4

Study Details

Study Description

Brief Summary

The aim of the study is to analyze the variability of plethysmography curve depending on the breath cycle (respiratory rate and tidal volume).

Condition or Disease Intervention/Treatment Phase
  • Other: Respiratory rate
  • Other: Tidal volume
  • Other: Apnea
N/A

Detailed Description

The plethysmography curve measured by finger sensors using pulse oximetry shows the changes in blood volume at the measured site. The presence of respiratory information within the pulse oximeter signal is a well-documented phenomenon. However, previous studies have mainly focused on extracting the respiratory rate from the plethysmography curve. The aim of this study is to analyze the variability of plethysmography curve as a function of both respiratory rate and tidal volume. Furthermore, the aim is to analyze the possibilities of apneic pause detection from the plethysmography curve.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
All participants go through all assigned interventions in one study arm.All participants go through all assigned interventions in one study arm.
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Plethysmography Curve Variability Depending on the Breath Cycle
Actual Study Start Date :
Mar 10, 2022
Anticipated Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Jun 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Measurement of plethysmography curve

Calm measurement of plethysmography curve using pulse oximetry with simultaneous monitoring of the breath cycle. In this experimental arm, participants will vary their breath cycle (different respiratory rates and different tidal volumes).

Other: Respiratory rate
The participant alternates respiratory rates of 30, 15 and 7.5 breaths/min. Breathe each frequency for 2 minutes with a one-minute break.

Other: Tidal volume
The participant alternates tidal volumes of approx. 2, 1 and 0.5 litres. Breathe each tidal volume for 2 minutes with a one-minute break.

Other: Apnea
The participant simulates three apneic pauses lasting 1 minute with a two-minute break.

Outcome Measures

Primary Outcome Measures

  1. Variability of plethysmography curve depending on the respiratory rate [1 hour]

    The effect of different respiratory rates (including apnea-zero respiratory rate) on the shape of the plethysmography curve will be evaluated.

  2. Variability of plethysmography curve depending on the tidal volume [1 hour]

    The effect of different tidal volumes (including apnea-zero tidal volume) on the shape of the plethysmography curve will be evaluated.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 30 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • healthy volunteers/students from the Czech Technical University in Prague
Exclusion Criteria:
  • any acute illness

  • pregnancy

  • severe cardiovascular conditions

  • severe asthma or other severe respiratory conditions

  • diabetes

  • hypotension or hypertension

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of Biomedical Engineering, Czech Technical University in Prague Kladno Czechia 27201

Sponsors and Collaborators

  • Czech Technical University in Prague

Investigators

  • Principal Investigator: Veronika Rafl Huttova, MSc, Czech Technical University in Prague
  • Principal Investigator: Jakub Rafl, PhD, Czech Technical University in Prague

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Czech Technical University in Prague
ClinicalTrials.gov Identifier:
NCT05302219
Other Study ID Numbers:
  • Plethysmography2022
First Posted:
Mar 31, 2022
Last Update Posted:
Mar 31, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Czech Technical University in Prague

Study Results

No Results Posted as of Mar 31, 2022