Healthy AdultNCT04964245
Respiratory Measurement of Volume Change Using Accelerometer, Thermographic Camera Electrical Impedance Tomography and Motion Correlation Analysis Using Mattress Sensor in Healthy Individuals
A study testing accelometer, thermographic camera and Electrical Impedance Tomography in people with Healthy Adult, run by Yonsei University at 1 site in South Korea.
Trial summary
Tidal volume can be the most important technical indicator for ventilation. Measuring the volume of breathing can be used as an indicator of how effective a patient's gas exchange is, and as a predictive indicator of the statue of respiratory disease indirectly. Read more about this study
- Who is it for?
- Ages 19 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult
- What is being tested?
- accelometer, thermographic camera and Electrical Impedance Tomography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2021to Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- over 19, under 50 years old and common BMI
- non-smoking, person without cardiopulmonary disease.
Who cannot join
- 1. smoking, cardiopulmonary, infectious diseases.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Severance Hospital, Yonsei University Health System
Seoul
Jeongmin Kim, +82 10-8926-2684, ANESJEONGMIN@yuhs.ac
About this study
Tidal volume can be the most important technical indicator for ventilation. Measuring the volume of breathing can be used as an indicator of how effective a patient's gas exchange is, and as a predictive indicator of the statue of respiratory disease indirectly. These Tidal volumes can be measured using spirometry and pneumotachograph, and the breathing volume and the rate of airflow can directly or indirectly evaluate the lung function of the patient.
However, spirometry has limitations that patients who are difficult to measure, and that it is difficult to measure in bed. In this work, the movement of the thorax due to breathing is measured in a non-invasive manner (accelerometer, thermographic camera) and the accuracy is compared through changes in thoracic impedance obtained through Pulmovista 500. Furthermore, we would like to correlate the motion of the measured object through a mattress sensor.
- Conditions
- Healthy Adult
- Being tested
- accelometer, thermographic camera, Electrical Impedance Tomography, Mattress Sensor
- Keywords
- Respiration, Tidal volume
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
accelometerDevice
the respiration parameters are measured using an accelometer.
thermographic cameraDevice
Also called FLIR 655sc
the respiration parameters are measured using an thermographic camera.
Electrical Impedance TomographyDevice
the respiration parameters are measured using an electrical impedance tomograhy.
Mattress SensorDevice
the respiration parameters are measured using an Mattress pressure
| Study group | Role | What they receive |
|---|---|---|
| Respiration monitoring group | Experimental | The respiration is simultaneously measured by accelerometer, thermographic camera, Impedance Tomography, and mattress sensor. Receives: Device: accelometer; Device: thermographic camera; Device: Electrical Impedance Tomography; Device: Mattress Sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
The accuracy of respiration measurements
The accuracy respiration measurements between thermographic camera, accelerometer, electrical impedance tomography, and mattress sensor.
Measured: about 20 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2021
- Study startJul 2021 (estimated)
- Primary completionAug 2021 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeongmin Kim, Principal investigator, Severance Hospital, Yonsei University Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04964245
- Sponsor's protocol ID
- 4-2020-1320
- Status last verified
- Jul 2021
- First submitted
- 1 Jul 2021
- Last updated
- 16 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Measurement of Volume Change Using Accelerometer, Thermographic Camera Electrical Impedance Tomography and Motion Correlation Analysis Using Mattress Sensor in Healthy Individuals
- ClinicalTrials.gov ID
- NCT04964245
- Acronym / sponsor ID
- 4-2020-1320
- Conditions
- Healthy Adult
- Keywords
- Respiration, Tidal volume
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jul 2021 (estimated)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 16 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Tidal volume can be the most important technical indicator for ventilation. Measuring the volume of breathing can be used as an indicator of how effective a patient's gas exchange is, and as a predictive indicator of the statue of respiratory disease indirectly. These Tidal volumes can be measured using spirometry and pneumotachograph, and the breathing volume and the rate of airflow can directly or indirectly evaluate the lung function of the patient.
However, spirometry has limitations that patients who are difficult to measure, and that it is difficult to measure in bed. In this work, the movement of the thorax due to breathing is measured in a non-invasive manner (accelerometer, thermographic camera) and the accuracy is compared through changes in thoracic impedance obtained through Pulmovista 500. Furthermore, we would like to correlate the motion of the measured object through a mattress sensor.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Respiration monitoring group | Experimental | Device: accelometer, Device: thermographic camera, Device: Electrical Impedance Tomography, Device: Mattress SensorThe respiration is simultaneously measured by accelerometer, thermographic camera, Impedance Tomography, and mattress sensor. |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- over 19, under 50 years old and common BMI
- non-smoking, person without cardiopulmonary disease.
Key exclusion criteria (1 listed)
- 1. smoking, cardiopulmonary, infectious diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| accelometerthe respiration parameters are measured using an accelometer. | Device | Respiration monitoring group |
| thermographic cameraAlso: FLIR 655scthe respiration parameters are measured using an thermographic camera. | Device | Respiration monitoring group |
| Electrical Impedance Tomographythe respiration parameters are measured using an electrical impedance tomograhy. | Device | Respiration monitoring group |
| Mattress Sensorthe respiration parameters are measured using an Mattress pressure | Device | Respiration monitoring group |
Primary outcome
The accuracy of respiration measurements
Time frame: about 20 min
The accuracy respiration measurements between thermographic camera, accelerometer, electrical impedance tomography, and mattress sensor.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Healthy Adult
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingPhase 1/2
Clinical Trial to Assess the Safety, Tolerability, Reactogenicity, and Immunogenicity of a 10 Valent Human Papillomavirus Virus (10vHPV) Vaccine
Human Papillomavirus Infection
Not yet recruiting
REM Enhancement Sleep Technology for Well-being, Emotion, and Life Lift
Healthy Adult Participants
Not yet recruitingPhase 1
Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates
Influenza
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeongmin Kim principal investigator
Severance Hospital, Yonsei University Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing accelometer, thermographic camera and Electrical Impedance Tomography in people with Healthy Adult, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeongmin Kim (+82 10-8926-2684, ANESJEONGMIN@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The accuracy of respiration measurements (time frame: about 20 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2021.