Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 9:01 PM
Study NCT ID:
NCT07489950
Status:
COMPLETED
Last Update Posted:
2026-03-24
First Post:
2026-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-apnea Saline-contrast EIT for Lung Perfusion Imaging in Spontaneously Breathing Patients: A Prospective Cross-over Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2026-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-18', 'studyFirstSubmitDate': '2026-03-18', 'studyFirstSubmitQcDate': '2026-03-18', 'lastUpdatePostDateStruct': {'date': '2026-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Spearman correlation coefficient (r)', 'timeFrame': 'Within 30 minutes', 'description': 'The Spearman correlation coefficient will be calculated to assess the voxel-by-voxel agreement of lung perfusion maps generated by the non-apnea algorithm compared to the reference standard (breath-hold method).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Spontaneous Breathing', 'Lung Perfusion', 'Electrical Impedance Tomography', 'Ventilation-Perfusion Matching'], 'conditions': ['Pulmonary Perfusion', 'Ventilation-Perfusion Ratio', 'Respiratory Insufficiency', 'Critical Illness']}, 'descriptionModule': {'briefSummary': 'Title: Validating the Accuracy of Lung Blood Flow Monitoring Without Breath-Holding Under Spontaneous Breathing Support\n\nPurpose: The purpose of this study is to evaluate the accuracy of a new Electrical Impedance Tomography (EIT) technique that measures lung blood flow (perfusion) without requiring patients to hold their breath. We aim to determine if this "non-apnea" method provides results consistent with the current clinical gold standard (the "pause" method).\n\nBackground: EIT is a non-invasive bedside tool used to monitor lung function. The traditional method for measuring lung blood flow requires patients to hold their breath for 5-8 seconds during a saline injection to avoid interference from breathing. However, many patients-especially those using a nasal cannula, high-flow nasal oxygen (HFNO), or pressure support ventilation (PSV)-must maintain continuous spontaneous breathing and find it difficult or unsafe to hold their breath. If a "non-apnea" method is proven accurate, it will make monitoring safer and easier for these patients.\n\nWhat the Study Involves: The study includes stable adult patients who are breathing spontaneously. Each patient undergoes two measurements in a randomized order:\n\nStandard Reference (Pause Method): Measurement taken during a brief, guided breath-hold.\n\nTest Method (Non-Apnea Method): Measurement taken during normal, uninterrupted breathing while receiving respiratory support (Nasal Cannula, HFNO, or PSV).\n\nExpected Significance: By comparing the lung images and ventilation/perfusion (V/Q) data from both methods, this study seeks to validate the reliability and precision of the non-apnea approach. This would allow clinicians to assess lung health in spontaneously breathing patients without interrupting their natural breathing rhythm.', 'detailedDescription': 'Study Design\n\nThis is a prospective, randomized, cross-over, within-subject validation study of accuracy.\n\nThe primary objective is to quantitatively assess the agreement between lung perfusion data acquired during uninterrupted spontaneous breathing (non-apnea method) and data acquired during the standard end-expiratory pause (pause method).\n\nParticipant Population and Respiratory Support\n\nThe study enrolls stable adult patients with active spontaneous breathing efforts.\n\nParticipants are categorized by the level of respiratory support they receive: Conventional Oxygen Therapy (Nasal Cannula), High-Flow Nasal Oxygen (HFNO), or Pressure Support Ventilation (PSV).\n\nConventional Oxygen Therapy includes patients using a nasal cannula or simple mask without pressure support.\n\nHFNO and PSV groups include patients receiving constant high-flow oxygen or patient-triggered mechanical ventilation.\n\nProcedures and Interventions\n\nEach participant receives two 10 mL boluses of 10% NaCl (hypertonic saline) via a central venous catheter.\n\nA 10-minute washout period is maintained between injections.\n\nIn the Pause Method, injection occurs during a 5-8 second end-expiratory hold (coached for nasal cannula/HFNO; ventilator-controlled for PSV).\n\nIn the Non-Apnea Method, injection occurs during continuous, ongoing breathing without any breathing commands or ventilator setting changes.\n\nTechnical Approach to Ensure Accuracy\n\nSpecialized algorithms are used to extract saline-contrast signals from the "noise" of spontaneous tidal breaths.\n\nAdvanced frequency filtering is applied to separate ventilation-related and perfusion-related impedance changes.\n\nIn non-apnea mode, the software identifies the perfusion window using a pixel-triggered approach.\n\nThis method detects the impedance drop relative to the End-Expiratory Lung Impedance (EELI) baseline to maintain precision despite moving baselines.\n\nOutcome Measures\n\nThe primary outcome is the pixel-wise correlation of perfusion maps between the two methods, assessed by the Spearman correlation coefficient (r).\n\nSecondary outcomes include the agreement of V/Q match%, dead space%, and shunt% using Bland-Altman analysis.\n\nThe study also assesses whether the type of support (Nasal Cannula vs. HFNO vs. PSV) affects the accuracy of the non-apnea method.\n\nFeasibility is documented by the success rate of analyzable acquisitions and categorized failure reasons.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged ≥ 18 years.\n\nRequiring respiratory support including Nasal Cannula, High-Flow Nasal Oxygen (HFNO), or Pressure Support Ventilation (PSV).\n\nHemodynamically stable.\n\nAble to tolerate a brief respiratory pause (for the reference group).\n\nSigned informed consent.\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding.\n\nContraindications to electrical impedance tomography (e.g., cardiac pacemaker, skin integrity issues on the chest).\n\nSevere circulatory failure or cardiogenic shock.\n\nKnown allergy to hypertonic saline.'}, 'identificationModule': {'nctId': 'NCT07489950', 'acronym': 'NELSB', 'briefTitle': 'Non-apnea Saline-contrast EIT for Lung Perfusion Imaging in Spontaneously Breathing Patients: A Prospective Cross-over Study', 'organization': {'class': 'OTHER', 'fullName': 'Ruijin Hospital'}, 'officialTitle': 'Non-apnea Saline-contrast EIT for Lung Perfusion Imaging in Spontaneously Breathing Patients: A Prospective Cross-over Study', 'orgStudyIdInfo': {'id': '2026063'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Breath-hold Method', 'description': "1. This arm serves as the reference standard for EIT perfusion measurement.\n2. A 10 mL bolus of 10% NaCl is injected during a 5-8 second end-expiratory pause.\n3. For patients on Nasal Cannula or HFNO, the pause is achieved via coached respiratory instruction; for patients on PSV, the ventilator's end-expiratory hold function is used", 'interventionNames': ['Diagnostic Test: Saline-contrast EIT with a non-apnea algorithm']}, {'type': 'EXPERIMENTAL', 'label': 'Non-apnea Method', 'description': '1. This arm evaluates the feasibility and accuracy of perfusion measurement during uninterrupted breathing.\n2. A 10 mL bolus of 10% NaCl is injected while the patient maintains a natural, continuous breathing rhythm.\n3. This method is tested across all included respiratory support modes, including Nasal Cannula, HFNO, and PSV, without any respiratory pause or instruction.', 'interventionNames': ['Diagnostic Test: Saline-contrast EIT with a non-apnea algorithm']}], 'interventions': [{'name': 'Saline-contrast EIT with a non-apnea algorithm', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['EIT Lung Perfusion Imaging'], 'description': 'Participants receive a central venous bolus injection of 10 mL 10% NaCl. Lung perfusion is then assessed using Electrical Impedance Tomography (EIT). The intervention evaluates two acquisition conditions: one during a brief respiratory pause (reference) and one during uninterrupted spontaneous breathing (test).', 'armGroupLabels': ['Non-apnea Method', 'Standard Breath-hold Method']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200025', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Department of Critical Care Medicine，Ruijin Hospital，Shanghai Jiao Tong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Hongping Qu', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Critical Care Medicine，Ruijin Hospital，Shanghai Jiao Tong University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ruijin Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}