Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:12 AM
Study NCT ID:
NCT04848727
Status:
COMPLETED
Last Update Posted:
2022-11-22
First Post:
2021-04-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Detection of Atelectasis or Pneumothorax and Resolution With Electrical Impedance Tomography (EIT) in Newborn Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011030', 'term': 'Pneumothorax'}], 'ancestors': [{'id': 'D010995', 'term': 'Pleural Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-06-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-18', 'studyFirstSubmitDate': '2021-04-09', 'studyFirstSubmitQcDate': '2021-04-13', 'lastUpdatePostDateStruct': {'date': '2022-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Compare respiratory rate', 'timeFrame': 'Baseline, pre-intervention/procedure/surgery and Immediately after the intervention/procedure/surgery', 'description': 'Compare the respiratory rate shown on the LuMon monitor and the one shown on other devices'}, {'measure': 'Compare total impedance from the ventilator and the LuMon device', 'timeFrame': 'Baseline, pre-intervention/procedure/surgery and Immediately after the intervention/procedure/surgery', 'description': 'Compare total impedance from the ventilator and the LuMon device'}, {'measure': 'Compare total volumes from the ventilator and the LuMon Device', 'timeFrame': 'Baseline, pre-intervention/procedure/surgery and Immediately after the intervention/procedure/surgery', 'description': 'Compare total volumes from the ventilator and the LuMon Device'}], 'primaryOutcomes': [{'measure': 'Atelectasis: Change in measured % Unventilated Lung between TimePeriods (t1 and t2)', 'timeFrame': 'Baseline, pre-intervention/procedure/surgery and Immediately after the intervention/procedure/surgery', 'description': 'Atelectasis will be calculated using the percentage of the lung fields that are not engaged in tidal volume.(VT)'}, {'measure': 'Pneumothorax: Change in measured % Unventilated Lung between TimePeriods (t1 and t2)', 'timeFrame': 'Baseline, pre-intervention/procedure/surgery and Immediately after the intervention/procedure/surgery', 'description': 'To determine pneumothorax is the percentage of lung areas with non-negligible impedance change during breathing.'}], 'secondaryOutcomes': [{'measure': 'Geometric Center of Ventilation (CoV)', 'timeFrame': 'Baseline, pre-intervention/procedure/surgery and Immediately after the intervention/procedure/surgery', 'description': 'In the human lung the ideal non-dependent to dependent CoV is 63%. Thus a value of 55% would indicate greater ventilation in the non-dependent lung.'}, {'measure': 'Change in % of total tidal volume (VT) within 8 lung regions', 'timeFrame': 'Baseline, pre-intervention/procedure/surgery and Immediately after the intervention/procedure/surgery', 'description': '% of total tidal volume will be determined from the trough and peak-to-peak height of the time-volume EIT within the 8 regions of interest'}, {'measure': 'Relative change in uncalibrated aeration (end-expiratory lung volume)', 'timeFrame': 'Baseline, pre-intervention/procedure/surgery and Immediately after the intervention/procedure/surgery', 'description': 'End-expiratory lung volume will be analyzed using four ventral to dorsal regions of interest (ROI) by EIT'}, {'measure': 'Regional distribution of tidal volume', 'timeFrame': 'Baseline, pre-intervention/procedure/surgery and Immediately after the intervention/procedure/surgery', 'description': 'Regional distribution of tidal volume will be analyzed using four ventral to dorsal regions of interest (ROI) by EIT'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Electrical Impedance Tomography'], 'conditions': ['Atelectasis Neonatal', 'Pneumothorax and Air Leak']}, 'referencesModule': {'references': [{'pmid': '19255741', 'type': 'BACKGROUND', 'citation': 'Costa EL, Borges JB, Melo A, Suarez-Sipmann F, Toufen C Jr, Bohm SH, Amato MB. Bedside estimation of recruitable alveolar collapse and hyperdistension by electrical impedance tomography. Intensive Care Med. 2009 Jun;35(6):1132-7. doi: 10.1007/s00134-009-1447-y. Epub 2009 Mar 3.'}, {'pmid': '27367888', 'type': 'BACKGROUND', 'citation': 'Miedema M, McCall KE, Perkins EJ, Sourial M, Bohm SH, Waldmann A, van Kaam AH, Tingay DG. First Real-Time Visualization of a Spontaneous Pneumothorax Developing in a Preterm Lamb Using Electrical Impedance Tomography. Am J Respir Crit Care Med. 2016 Jul 1;194(1):116-8. doi: 10.1164/rccm.201602-0292LE. No abstract available.'}, {'pmid': '31091957', 'type': 'BACKGROUND', 'citation': 'Rahtu M, Frerichs I, Waldmann AD, Strodthoff C, Becher T, Bayford R, Kallio M. Early Recognition of Pneumothorax in Neonatal Respiratory Distress Syndrome with Electrical Impedance Tomography. Am J Respir Crit Care Med. 2019 Oct 15;200(8):1060-1061. doi: 10.1164/rccm.201810-1999IM. No abstract available.'}, {'pmid': '32884798', 'type': 'BACKGROUND', 'citation': 'Kallio M, Rahtu M, van Kaam AH, Bayford R, Rimensberger PC, Frerichs I. Electrical impedance tomography reveals pathophysiology of neonatal pneumothorax during NAVA. Clin Case Rep. 2020 May 24;8(8):1574-1578. doi: 10.1002/ccr3.2944. eCollection 2020 Aug.'}], 'seeAlsoLinks': [{'url': 'http://www.sentec.com/education/eit/plpm-eit', 'label': 'Design/patents related to the Lumon System'}]}, 'descriptionModule': {'briefSummary': 'To validate the benefits of recognizing asymmetric lung disease like atelectasis and pneumothorax in neonatal respiratory distress syndrome using electrical impedance tomography', 'detailedDescription': 'To quantify the changes in regional lung air content associated with the variations of the respiratory support settings, the following approach will be used. The changes in local air content will be determined in the selected EIT region of interest (ROI) in terms of a change in local average lung density and relative impedance change with respect to a reference air content.\n\n* TimePeriod 1 (t1): The reference lung air content will be measured once the asymmetric lung disease is identified on chest x-ray.\n* TimePeriod 2 (t2): A post-lung disease EIT measurement will be obtained at 6-24 hours later or immediately after therapy (i.e. chest tube placement or needle decompression).\n\nEligible infants with confirmed asymmetric lung disease (atelectasis or pneumothorax) by radiographic images requiring no respiratory support or on mechanical support or nCPAP therapy of 5-8 cm H20 achieved with a ventilator, an underwater "bubble" system, or a variable-flow device will be enrolled. All of these methods of providing the therapy are done with FDA approved devices currently used in the NICU.\n\nEIT data will be acquired using The LuMon Monitor-Neo, GUI software 1.0.x.x/TIC software 1.6.x.xxx (SenTec, Landquart, Switzerland). The EIT system will be placed at the subject\'s bedside to collect EIT measurements: Ventilation distribution%, changes in regional aeration in arbitrary units (AU), dependent and non-dependent silent spaces.\n\nA data acquisition cart will also be placed at the subject\'s bedside to collect hemodynamic and respiratory parameters measurements including: Heart rate (HR), blood pressure (BP), respiratory rate (RR), fraction of inspired oxygen (FiO2), transcutaneous carbon dioxide (TcCO2), and peripheral oxygen saturation (SpO2) via bedside monitoring devices.\n\nThe LuMon belts for neonates are disposable single-patient use belts that are adhesive-free and consists of 32 electrodes which are sized to the infant\'s chest circumference, generally at the 4th - 6th rib. Warmed NeoContactAgent (ingredients: Aqua, Glycerol, Sodium chloride) will be applied to the belt before placing on the infant. The embedded position sensor permits the LuMon System to measure and display the patient\'s position. The soft and expandable closure band prevents the chest from being constrained by the belt and, consequently, prevents restrictions to breathing and increased work of breathing.\n\nEIT measurements and data will be collected on each timeperiods (t1 and t2) for approximately 15-30 minutes on invasive or non-invasive ventilatory support.\n\nThe EIT measurements may be repeated on an eligible participant if a reoccurrence of a confirmed asymmetric lung disease, atelectasis or pneumothorax, is identified on a radiographic image.\n\nEIT is currently not used for patient care management at SMBHWN. EIT\'s use for patient care management is purely experimental. EIT, when used solely for physiologic data collection, its use is not subject to 21 CFR 50, 21 CFR 56, or 21 CFR 812. Data collection via EIT will occur when the subject is in a quiet, sleeping state, and can be accomplished in a convenient time period when care givers or parents are not interacting with the subject.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All infants admitted to the Neonatal Intensive Care Unit (NICU) at Sharp Mary Birch Hospital for Women \\& Newborns with confirmed asymmetric lung disease (atelectasis or pneumothorax) by radiographic images requiring no respiratory support or on mechanical support or nCPAP therapy of 5-8 cm H20 achieved with a ventilator, an underwater "bubble" system, or a variable-flow device will be enrolled', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. All infants admitted to the NICU at SMBHWN\n2. Informed consent obtained\n3. Atelectasis confirmed on CXR\n4. Pneumothorax confirmed on CXR\n\nExclusion Criteria:\n\n1. Declined consent\n2. Infants with known congenital anomalies'}, 'identificationModule': {'nctId': 'NCT04848727', 'acronym': 'DePIcT', 'briefTitle': 'Detection of Atelectasis or Pneumothorax and Resolution With Electrical Impedance Tomography (EIT) in Newborn Infants', 'organization': {'class': 'OTHER', 'fullName': 'Sharp HealthCare'}, 'officialTitle': 'Detection of Atelectasis or Pneumothorax and Resolution With Electrical Impedance Tomography (EIT) in Newborn Infants', 'orgStudyIdInfo': {'id': 'DePIct'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Atelectasis or Pneumothorax', 'description': 'Infants with asymmetric lung disease (i.e. atelectasis or pneumothorax) confirmed by chest radiograph', 'interventionNames': ['Other: Detecting asymmetric lung disease like atelectasis or pneumothorax with electrical impedance tomography (EIT)']}], 'interventions': [{'name': 'Detecting asymmetric lung disease like atelectasis or pneumothorax with electrical impedance tomography (EIT)', 'type': 'OTHER', 'description': "The EIT system will be placed at the subject's bedside to collect EIT measurements: Ventilation distribution%, changes in regional aeration in arbitrary units (AU), dependent and non-dependent silent spaces. A data acquisition cart will also be placed at the subject's bedside to collect hemodynamic and respiratory parameters measurements including: Heart rate (HR), blood pressure (BP), respiratory rate (RR), fraction of inspired oxygen (FiO2), transcutaneous carbon dioxide (TcCO2), and peripheral oxygen saturation (SpO2) via bedside monitoring devices.\n\nThe LuMon belts for neonates are disposable single-patient use belts that are adhesive-free. EIT measurements and data will be collected on each timeperiods (t1 and t2) for approximately 15-30 minutes on invasive or non-invasive ventilatory support.", 'armGroupLabels': ['Atelectasis or Pneumothorax']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Sharp Mary Birch Hospital for Women & Newborns', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'overallOfficials': [{'name': 'Anup C Katheria, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sharp HealthCare'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sharp HealthCare', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director Neonatal Research Institute', 'investigatorFullName': 'Anup Katheria, M.D.', 'investigatorAffiliation': 'Sharp HealthCare'}}}}