NCT05302219

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2022

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

March 16, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 31, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

March 25, 2025

Status Verified

March 1, 2025

Enrollment Period

4 months

First QC Date

March 16, 2022

Last Update Submit

March 24, 2025

Conditions

ApneaCirculatory; ChangeRespiration

Keywords

pulse oximetryphotoplethysmography curvebreath cycleapnea

Outcome Measures

Primary Outcomes (2)

  • Variability of plethysmography curve depending on the respiratory rate

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

    1 hour

  • Variability of plethysmography curve depending on the tidal volume

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

    1 hour

Study Arms (1)

Measurement of plethysmography curve

EXPERIMENTAL

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 rateOther: Tidal volumeOther: Apnea

Interventions

Respiratory rateOTHER

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

Measurement of plethysmography curve
Tidal volumeOTHER

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.

Measurement of plethysmography curve
ApneaOTHER

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

Measurement of plethysmography curve

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy volunteers/students from the Czech Technical University in Prague

You may not qualify if:

  • any acute illness
  • pregnancy
  • severe cardiovascular conditions
  • severe asthma or other severe respiratory conditions
  • diabetes
  • hypotension or hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Biomedical Engineering, Czech Technical University in Prague

Kladno, 27201, Czechia

Location

Related Publications (1)

  • Nilsson LM. Respiration signals from photoplethysmography. Anesth Analg. 2013 Oct;117(4):859-865. doi: 10.1213/ANE.0b013e31828098b2. Epub 2013 Feb 28.

    PMID: 23449854BACKGROUND

MeSH Terms

Conditions

ApneaRespiratory Aspiration

Interventions

Respiratory RateTidal VolumeN(6)-2-(4-aminophenyl)ethyladenosine

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Intervention Hierarchy (Ancestors)

Vital SignsPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisRespirationRespiratory Physiological PhenomenaCirculatory and Respiratory Physiological PhenomenaInspiratory CapacityVital CapacityTotal Lung CapacityLung Volume MeasurementsRespiratory Function TestsDiagnostic Techniques, Respiratory System

Study Officials

  • Veronika Rafl Huttova, MSc

    Czech Technical University in Prague

    PRINCIPAL INVESTIGATOR

  • Jakub Rafl, PhD

    Czech Technical University in Prague

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: All participants go through all assigned interventions in one study arm.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2022

First Posted

March 31, 2022

Study Start

March 10, 2022

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

March 25, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

CZ(1)