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To validate the benefits of recognizing asymmetric lung disease like atelectasis and pneumothorax in neonatal respiratory distress syndrome using electrical impedance tomography
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.
Eligible 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.
EIT 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.
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.
The 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.
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.
The 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.
EIT 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.
Primary analyses compare EIT-derived ventilation distribution metrics between t1 and t2, including % unventilated lung and indices of ventilation inhomogeneity (e.g., GI). Analyses will also be reported overall and, where sample size permits, stratified by radiographic diagnosis (atelectasis vs pneumothorax).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atelectasis or Pneumothorax | Infants with asymmetric lung disease (i.e. atelectasis or pneumothorax) confirmed by chest radiograph |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Detecting asymmetric lung disease like atelectasis or pneumothorax with electrical impedance tomography (EIT) | Other | 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. The 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Atelectasis: Change in measured % Unventilated Lung between TimePeriods (t1 and t2) | Atelectasis will be calculated using the percentage of the lung fields that are not engaged in tidal volume.(VT) | Baseline, pre-intervention/procedure/surgery and Immediately after the intervention/procedure/surgery |
| Pneumothorax: Change in measured % Unventilated Lung between TimePeriods (t1 and t2) | To determine pneumothorax is the percentage of lung areas with non-negligible impedance change during breathing. | Baseline, pre-intervention/procedure/surgery and Immediately after the intervention/procedure/surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Center of Ventilation (CoV) | 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. | Baseline, pre-intervention/procedure/surgery and Immediately after the intervention/procedure/surgery |
| Change in % of total tidal volume (VT) within 8 lung regions |
| Measure | Description | Time Frame |
|---|---|---|
| Compare respiratory rate | Compare the respiratory rate shown on the LuMon monitor and the one shown on other devices | Baseline, pre-intervention/procedure/surgery and Immediately after the intervention/procedure/surgery |
| Compare total impedance from the ventilator and the LuMon device |
Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Anup C Katheria, MD | Sharp HealthCare | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sharp Mary Birch Hospital for Women & Newborns | San Diego | California | 92123 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19255741 | Background | 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. | |
| 27367888 | Background | 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. |
| Label | URL |
|---|---|
| Design/patents related to the Lumon System | View source |
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% 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 |
| Baseline, pre-intervention/procedure/surgery and Immediately after the intervention/procedure/surgery |
| Relative change in uncalibrated aeration (end-expiratory lung volume) | End-expiratory lung volume will be analyzed using four ventral to dorsal regions of interest (ROI) by EIT | Baseline, pre-intervention/procedure/surgery and Immediately after the intervention/procedure/surgery |
| Regional distribution of tidal volume | Regional distribution of tidal volume will be analyzed using four ventral to dorsal regions of interest (ROI) by EIT | Baseline, pre-intervention/procedure/surgery and Immediately after the intervention/procedure/surgery |
| Change in Global Inhomogeneity (GI) index between t1 and t2 | GI index computed from EIT data; reported as ΔGI = GI(t2) - GI(t1), with negative values indicating improved homogeneity. | TimePeriod 1 (t1): at time of radiographic diagnosis of atelectasis/pneumothorax; TimePeriod 2 (t2): 6-24 hours after t1 or immediately after clinical therapy (e.g., chest tube placement/needle decompression), whichever occurs first. |
Compare total impedance from the ventilator and the LuMon device |
| Baseline, pre-intervention/procedure/surgery and Immediately after the intervention/procedure/surgery |
| Compare total volumes from the ventilator and the LuMon Device | Compare total volumes from the ventilator and the LuMon Device | Baseline, pre-intervention/procedure/surgery and Immediately after the intervention/procedure/surgery |
| 31091957 | Background | 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. |
| 32884798 | Background | 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. |
| ID | Term |
|---|---|
| D011030 | Pneumothorax |
| ID | Term |
|---|---|
| D010995 | Pleural Diseases |
| D012140 | Respiratory Tract Diseases |
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