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

Sponsor
Yonsei University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05591469
Collaborator
(none)
20
1
2
14
1.4

Study Details

Study Description

Brief 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. 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.

Condition or Disease Intervention/Treatment Phase
  • Device: IR Camera
  • Device: Electrical Impedance Tomography
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Respiratory Measurement Using Infrared Camera and Electrical Impedance Tomography for Sedation in Patients Undergoing TURP/TURB Under Spinal Anesthesia
Actual Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Nov 1, 2022
Anticipated Study Completion Date :
Nov 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. The accuracy of respiration measurements [Experiment period about 20 minutes]

    The accuracy respiration measurements between IR camera and electrical impedance tomography.

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 99 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Yonsei University Health System, Severance Hospital Seoul Korea, Republic of

Sponsors and Collaborators

  • Yonsei University

Investigators

  • Principal Investigator: Jeongmin Kim, Severance Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Yonsei University
ClinicalTrials.gov Identifier:
NCT05591469
Other Study ID Numbers:
  • 4-2022-0864
First Posted:
Oct 24, 2022
Last Update Posted:
Oct 24, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Oct 24, 2022