- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05302219
Plethysmography Curve Variability Depending on the Breath Cycle
March 24, 2025 updated by: Czech Technical University in Prague
The aim of the study is to analyze the variability of plethysmography curve depending on the breath cycle (respiratory rate and tidal volume).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Kladno, Czechia, 27201
- Faculty of biomedical Engineering, Czech Technical University in Prague
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 30 years (Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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).
|
The participant alternates respiratory rates of 30, 15 and 7.5 breaths/min.
Breathe each frequency for 2 minutes with a one-minute break.
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.
The participant simulates three apneic pauses lasting 1 minute with a two-minute break.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Variability of plethysmography curve depending on the respiratory rate
Time Frame: 1 hour
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The effect of different respiratory rates (including apnea-zero respiratory rate) on the shape of the plethysmography curve will be evaluated.
|
1 hour
|
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Variability of plethysmography curve depending on the tidal volume
Time Frame: 1 hour
|
The effect of different tidal volumes (including apnea-zero tidal volume) on the shape of the plethysmography curve will be evaluated.
|
1 hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Veronika Rafl Huttova, MSc, Czech Technical University in Prague
- Principal Investigator: Jakub Rafl, PhD, Czech Technical University in Prague
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 10, 2022
Primary Completion (Actual)
June 30, 2022
Study Completion (Actual)
June 30, 2022
Study Registration Dates
First Submitted
March 16, 2022
First Submitted That Met QC Criteria
March 29, 2022
First Posted (Actual)
March 31, 2022
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
March 24, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- Plethysmography2022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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