Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2026-02-23 @ 11:34 AM
Study NCT ID:
NCT07081295
Status:
COMPLETED
Last Update Posted:
2025-07-23
First Post:
2025-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
New Saline-contrast EIT Method Without Breath Hold by Low Pass Filter
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008171', 'term': 'Lung Diseases'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-09-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-15', 'studyFirstSubmitDate': '2025-07-02', 'studyFirstSubmitQcDate': '2025-07-15', 'lastUpdatePostDateStruct': {'date': '2025-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Regional V/Q match', 'timeFrame': 'Offline analysis, immediately after the saline injection procedure'}], 'secondaryOutcomes': [{'measure': 'Pixel-wise lung perfusion fraction', 'timeFrame': 'Offline analysis, immediately after the saline injection procedure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Diseases']}, 'descriptionModule': {'briefSummary': 'The electrical impedance tomography (EIT) is a bedside, non-invasive, non-radiation imaging tool for lung mornitoring. Currently, the EIT saline-contrast method for lung perfusion evaluation has been widely used in clinical. However, this technique requires the patient to hold breath for 8-30s to avoid the respiratory interference. Hence, it is not suitable for patients that can not tolerate breath hold or unable to maintain a steady apnoea. This study aims to develop an algorithm system based on low frequency band pass filter for EIT saline-contrast lung perfusion estimation without ventilation interruption, and investigate the correlation and agreement of EIT results between the novel method and the conventional breath-hold method.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* In need of lung perfusion assessment due to clinical condition\n* With central venous catheter\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding females\n* contraindications to the use of EIT (automatic implantable cardioverter defibrillator, chest wounds limiting electrode belt placement, implantable pumps, etc.)\n* severe hyperchloremia (\\>155 mmol/L)\n* unable to tolerate breath-hold maneuver\n* edema disease (nephrotic syndrome, cirrhotic ascites, congestive heart failure, etc.)\n* Patients with severe hypernatraemia or hyperchloremia and severe hypertonicity\n* Hypertension (\\>160/100 mmHg), hypokalaemia (\\> 3.5 mmol/L)\n* Acute renal failure in oliguric stage, chronic renal failure with reduced urine output and poor response to diuretics'}, 'identificationModule': {'nctId': 'NCT07081295', 'briefTitle': 'New Saline-contrast EIT Method Without Breath Hold by Low Pass Filter', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'A Novel Saline-contrast EIT Method for Lung Perfusion Estimation: Without Breath Hold by Low Frequency Band Pass Filter', 'orgStudyIdInfo': {'id': 'EIT-No breath hold'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'No apnea group', 'description': 'First, perform the EIT saline contrast method without apnea. After a 10-minute washout period, perform the conventional saline contrast method with apnea.', 'interventionNames': ['Other: Injection of hypertonic saline']}, {'type': 'OTHER', 'label': 'Apnea group', 'description': 'First, perform the conventional EIT saline contrast method with apnea. After a 10-minute washout period, perform the saline contrast method without apnea.', 'interventionNames': ['Other: Injection of hypertonic saline']}], 'interventions': [{'name': 'Injection of hypertonic saline', 'type': 'OTHER', 'description': 'Injection 10 mL of 10% NaCl through central venous catheter', 'armGroupLabels': ['Apnea group', 'No apnea group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100730', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}