Patients Undergoing Transurethral Prostate or Cystectomy Under Spinal AnesthesiaNCT05591469
Respiratory Measurement Using Infrared Camera and Electrical Impedance Tomography for Sedation in Patients Undergoing TURP/TURB Under Spinal Anesthesia
A study testing IR Camera and Electrical Impedance Tomography in people with Patients Undergoing Transurethral Prostate or Cystectomy Under Spinal Anesthesia, run by Yonsei University at 1 site in South Korea.
Trial summary
Tidal volume may be the most important technical indicator for ventilation. Measuring tidal volume can be used as an indicator of how effective a patient's gas exchange is, and can also be used as a predictive indicator to indirectly predict the severity of respiratory disease. Read more about this study
- Who is it for?
- Ages 19 to 99 years, men only
- Conditions the study is for
- Patients Undergoing Transurethral Prostate or Cystectomy Under Spinal Anesthesia
- What is being tested?
- IR Camera and Electrical Impedance Tomography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Sep 2022to Nov 2023
- 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 99 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A male aged 19 years or older
- normal BMI
- patients undergoing transurethral prostate or cystectomy under spinal anesthesia
Who cannot join
- Presenting alteration in respiratory function detected by functional analysis of lung volume and capacity- pneumonectomy patient, severe ipsilateral destroyed lung patient
- Inability to understand or perform the procedure.
- ASA class 4, 5
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Yonsei University Health System, Severance Hospital
Seoul
Jeongmin Kim, +82 10-8926-2684, ANESJEONGMIN@yuhs.ac
About this study
Tidal volume may be the most important technical indicator for ventilation. Measuring tidal volume can be used as an indicator of how effective a patient's gas exchange is, and can also be used as a predictive indicator to indirectly predict the severity of respiratory disease. This tidal volume can be measured using spirometry and pneumotachograph, and the lung function of the patient can be assessed directly or indirectly through the respiratory volume and air flow velocity. In addition, the measurement itself can change the patient's breathing pattern, and for accurate measurement, it has to be carried out in a certain space, so there is a limitation in that it is difficult to measure in a hospital bed or in a laboratory. To overcome this limitation, various methods have been introduced. The basic principle is that the tidal volume is directly proportional to the movement of the chest and proportional to the change in the length of the circumference of the chest. Over the past decade, several studies have been conducted to measure respiratory mechanics in a non-invasive way. Methods using thoracic impedance, acoustic monitoring, strain gauges, and magnetometers have been developed. Non-invasive, non-contact imaging methods have also been developed, such as thermal image, structured light plethysmography (SLP), and optoelectronic plethysmography (OEP). Therefore, in this study, the thoracic movement due to respiration was measured with a non-invasive method (IR camera), and the accuracy was compared through the impedance change obtained through impedance tomography to evaluate the effectiveness of the non-invasive equipment.
- Being tested
- IR Camera, Electrical Impedance Tomography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IR CameraDevice
the respiration parameters are measured using an IR camera.
Electrical Impedance TomographyDevice
the respiration parameters are measured using an electrical impedance tomograhy.
| Study group | Role | What they receive |
|---|---|---|
| Noncontact Respiration monitoring group | Experimental | Not described Receives: Device: IR Camera |
| Contact Respiration monitoring group | Experimental | Not described Receives: Device: Electrical Impedance Tomography |
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 IR camera and electrical impedance tomography.
Measured: Experiment period about 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2022
- Study start1 Sep 2022
- Primary completionNov 2022 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Patients Undergoing Transurethral Prostate or Cystectomy Under Spinal AnesthesiaStudies 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05591469
- Sponsor's protocol ID
- 4-2022-0864
- Status last verified
- Oct 2022
- First submitted
- 13 Oct 2022
- Last updated
- 24 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kim J, Kwon JH, Kim E, Yoo SK, Shin CS. Respiratory measurement using infrared thermography and respiratory volume monitor during sedation in patients undergoing endoscopic urologic procedures under spinal anesthesia. J Clin Monit Comput. 2019 Aug;33(4):647-656. doi: 10.1007/s10877-018-0214-4. Epub 2018 Nov 14.
PubMed 30426322Kwon J, Kwon O, Oh K, Kim J, Shin CS, Yoo SK. Thermodiluted relative tidal volume estimation using a thermal camera in operating room under spinal anesthesia. Biomed Eng Online. 2022 Sep 7;21(1):64. doi: 10.1186/s12938-022-01028-0.
PubMed 36071495
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Measurement Using Infrared Camera and Electrical Impedance Tomography for Sedation in Patients Undergoing TURP/TURB Under Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT05591469
- Acronym / sponsor ID
- 4-2022-0864
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 24 Oct 2022 (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 may be the most important technical indicator for ventilation. Measuring tidal volume can be used as an indicator of how effective a patient's gas exchange is, and can also be used as a predictive indicator to indirectly predict the severity of respiratory disease. This tidal volume can be measured using spirometry and pneumotachograph, and the lung function of the patient can be assessed directly or indirectly through the respiratory volume and air flow velocity. In addition, the measurement itself can change the patient's breathing pattern, and for accurate measurement, it has to be carried out in a certain space, so there is a limitation in that it is difficult to measure in a hospital bed or in a laboratory. To overcome this limitation, various methods have been introduced. The basic principle is that the tidal volume is directly proportional to the movement of the chest and proportional to the change in the length of the circumference of the chest. Over the past decade, several studies have been conducted to measure respiratory mechanics in a non-invasive way. Methods using thoracic impedance, acoustic monitoring, strain gauges, and magnetometers have been developed. Non-invasive, non-contact imaging methods have also been developed, such as thermal image, structured light plethysmography (SLP), and optoelectronic plethysmography (OEP). Therefore, in this study, the thoracic movement due to respiration was measured with a non-invasive method (IR camera), and the accuracy was compared through the impedance change obtained through impedance tomography to evaluate the effectiveness of the non-invasive equipment.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Noncontact Respiration monitoring group | Experimental | Device: IR Camera |
| Contact Respiration monitoring group | Experimental | Device: Electrical Impedance Tomography |
Who may qualify
- Ages
- 19 to 99 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- A male aged 19 years or older
- normal BMI
- patients undergoing transurethral prostate or cystectomy under spinal anesthesia
Key exclusion criteria (3 listed)
- Presenting alteration in respiratory function detected by functional analysis of lung volume and capacity- pneumonectomy patient, severe ipsilateral destroyed lung patient
- Inability to understand or perform the procedure.
- ASA class 4, 5
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 |
|---|---|---|
| IR Camerathe respiration parameters are measured using an IR camera. | Device | Noncontact Respiration monitoring group |
| Electrical Impedance Tomographythe respiration parameters are measured using an electrical impedance tomograhy. | Device | Contact Respiration monitoring group |
Primary outcome
The accuracy of respiration measurements
Time frame: Experiment period about 20 minutes
The accuracy respiration measurements between IR camera and electrical impedance tomography.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2022.
- Background: PubMed 30426322Kim J, Kwon JH, Kim E, Yoo SK, Shin CS. Respiratory measurement using infrared thermography and respiratory volume monitor during sedation in patients undergoing endoscopic urologic procedures under spinal anesthesia. J Clin Monit Comput. 2019 Aug;33(4):647-656. doi: 10.1007/s10877-018-0214-4. Epub 2018 Nov 14.
- Background: PubMed 36071495Kwon J, Kwon O, Oh K, Kim J, Shin CS, Yoo SK. Thermodiluted relative tidal volume estimation using a thermal camera in operating room under spinal anesthesia. Biomed Eng Online. 2022 Sep 7;21(1):64. doi: 10.1186/s12938-022-01028-0.
- Individual participant dataSharing planned: Undecided
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IR Camera and Electrical Impedance Tomography in people with Patients Undergoing Transurethral Prostate or Cystectomy Under Spinal Anesthesia, 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 3 inclusion and 3 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 24 Oct 2022. 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: Experiment period about 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05591469, which also lists 2 linked publications.
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 24 Oct 2022.