An observational study in Atelectasis Neonatal and Pneumothorax and Air Leak, sponsored by Sharp HealthCare. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2026-04-22.
Sponsored by Sharp HealthCare · Observational
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).
178 studies on the registry are indexed under Pneumothorax; 42 are open to participants now.
This study's enrollment of 20 is below the median of 121 across 58 observational studies indexed under Pneumothorax.
Browse Pneumothorax studies →Sharp HealthCare is the lead sponsor of 40 studies on the registry; 4 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
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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
Exclusion Criteria:
Infants with asymmetric lung disease (i.e. atelectasis or pneumothorax) confirmed by chest radiograph
Other: Detecting asymmetric lung disease like atelectasis or pneumothorax with electrical impedance tomography (EIT)
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.
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)
Time frame: 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.
Time frame: Baseline, pre-intervention/procedure/surgery and Immediately after the intervention/procedure/surgery
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.
Time frame: Baseline, pre-intervention/procedure/surgery and Immediately after the intervention/procedure/surgery
Change in % of total tidal volume (VT) within 8 lung regions
% 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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 respiratory rate
Compare the respiratory rate shown on the LuMon monitor and the one shown on other devices
Time frame: Baseline, pre-intervention/procedure/surgery and Immediately after the intervention/procedure/surgery
Compare total impedance from the ventilator and the LuMon device
Compare total impedance from the ventilator and the LuMon device
Time frame: 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
Time frame: Baseline, pre-intervention/procedure/surgery and Immediately after the intervention/procedure/surgery
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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