NCT04964245

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 16, 2021

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

July 16, 2021

Status Verified

July 1, 2021

Enrollment Period

1 month

First QC Date

July 1, 2021

Last Update Submit

July 15, 2021

Conditions

Keywords

RespirationTidal volume

Outcome Measures

Primary Outcomes (1)

  • The accuracy of respiration measurements

    The accuracy respiration measurements between thermographic camera, accelerometer, electrical impedance tomography, and mattress sensor.

    about 20 min

Study Arms (1)

Respiration monitoring group

EXPERIMENTAL

The respiration is simultaneously measured by accelerometer, thermographic camera, Impedance Tomography, and mattress sensor.

Device: accelometerDevice: thermographic cameraDevice: Electrical Impedance TomographyDevice: Mattress Sensor

Interventions

the respiration parameters are measured using an accelometer.

Respiration monitoring group

the respiration parameters are measured using an thermographic camera.

Also known as: FLIR 655sc
Respiration monitoring group

the respiration parameters are measured using an electrical impedance tomograhy.

Respiration monitoring group

the respiration parameters are measured using an Mattress pressure

Respiration monitoring group

Eligibility Criteria

Age19 Years - 50 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • over 19, under 50 years old and common BMI
  • non-smoking, person without cardiopulmonary disease.

You may not qualify if:

  • \. smoking, cardiopulmonary, infectious diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Location

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jeongmin Kim

    Severance Hospital, Yonsei University Health System

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

July 1, 2021

First Posted

July 16, 2021

Study Start

July 1, 2021

Primary Completion

August 1, 2021

Study Completion

August 1, 2021

Last Updated

July 16, 2021

Record last verified: 2021-07

Locations