Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-25 @ 8:26 PM
Study NCT ID:
NCT05591469
Status:
UNKNOWN
Last Update Posted:
2022-10-24
First Post:
2022-10-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Respiratory Measurement Using Infrared Camera and Electrical Impedance Tomography for Sedation in Patients Undergoing TURP/TURB Under Spinal Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2023-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-21', 'studyFirstSubmitDate': '2022-10-13', 'studyFirstSubmitQcDate': '2022-10-21', 'lastUpdatePostDateStruct': {'date': '2022-10-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The accuracy of respiration measurements', 'timeFrame': 'Experiment period about 20 minutes', 'description': 'The accuracy respiration measurements between IR camera and electrical impedance tomography.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Patients Undergoing Transurethral Prostate or Cystectomy Under Spinal Anesthesia']}, 'referencesModule': {'references': [{'pmid': '30426322', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '36071495', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A male aged 19 years or older\n* normal BMI\n* patients undergoing transurethral prostate or cystectomy under spinal anesthesia\n\nExclusion Criteria:\n\n* Presenting alteration in respiratory function detected by functional analysis of lung volume and capacity- pneumonectomy patient, severe ipsilateral destroyed lung patient\n* Inability to understand or perform the procedure.\n* ASA class 4, 5'}, 'identificationModule': {'nctId': 'NCT05591469', 'briefTitle': 'Respiratory Measurement Using Infrared Camera and Electrical Impedance Tomography for Sedation in Patients Undergoing TURP/TURB Under Spinal Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'Respiratory Measurement Using Infrared Camera and Electrical Impedance Tomography for Sedation in Patients Undergoing TURP/TURB Under Spinal Anesthesia', 'orgStudyIdInfo': {'id': '4-2022-0864'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Noncontact Respiration monitoring group', 'interventionNames': ['Device: IR Camera']}, {'type': 'EXPERIMENTAL', 'label': 'Contact Respiration monitoring group', 'interventionNames': ['Device: Electrical Impedance Tomography']}], 'interventions': [{'name': 'IR Camera', 'type': 'DEVICE', 'description': 'the respiration parameters are measured using an IR camera.', 'armGroupLabels': ['Noncontact Respiration monitoring group']}, {'name': 'Electrical Impedance Tomography', 'type': 'DEVICE', 'description': 'the respiration parameters are measured using an electrical impedance tomograhy.', 'armGroupLabels': ['Contact Respiration monitoring group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jeongmin Kim', 'role': 'CONTACT', 'email': 'ANESJEONGMIN@yuhs.ac', 'phone': '+82 10-8926-2684'}], 'facility': 'Yonsei University Health System, Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Jeongmin Kim', 'role': 'CONTACT', 'email': 'ANESJEONGMIN@yuhs.ac', 'phone': '+82 10-8926-2684'}], 'overallOfficials': [{'name': 'Jeongmin Kim', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Severance Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}