Respiratory Measurement Using Infrared Camera and Electrical Impedance Tomography for Sedation in Patients Undergoing TURP/TURB Under Spinal Anesthesia

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 Overview

• Status: Recruiting
• Conditions: Patients Undergoing Transurethral Prostate or Cystectomy Under Spinal Anesthesia
• Intervention / Treatment: Device: IR Camera; Device: Electrical Impedance Tomography

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jeongmin Kim; Phone Number: +82 10-8926-2684; Email: ANESJEONGMIN@yuhs.ac

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Yonsei University Health System, Severance Hospital
    • Contact: Jeongmin Kim; Phone Number: +82 10-8926-2684; Email: ANESJEONGMIN@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• A male aged 19 years or older
• normal BMI
• patients undergoing transurethral prostate or cystectomy under spinal anesthesia

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Noncontact Respiration monitoring group	Device: IR Camera; the respiration parameters are measured using an IR camera.
Experimental: Contact Respiration monitoring group	Device: Electrical Impedance Tomography; the respiration parameters are measured using an electrical impedance tomograhy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The accuracy of respiration measurements	The accuracy respiration measurements between IR camera and electrical impedance tomography.	Experiment period about 20 minutes

Collaborators and Investigators

• Sponsor: Yonsei University
• Investigators: Principal Investigator: Jeongmin Kim, Severance Hospital

Publications and helpful links

General 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. Erratum In: J Clin Monit Comput. 2021 May;35(3):675.
• Kwon 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Anticipated): November 1, 2022
• Study Completion (Anticipated): November 1, 2023

Study Registration Dates

• First Submitted: October 13, 2022
• First Submitted That Met QC Criteria: October 21, 2022
• First Posted (Actual): October 24, 2022

Study Record Updates

• Last Update Posted (Actual): October 24, 2022
• Last Update Submitted That Met QC Criteria: October 21, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 4-2022-0864

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No