Detection of Atelectasis or Pneumothorax and Resolution With Electrical Impedance Tomography (EIT) in Newborn Infants

Study Overview
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Brief Summary
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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

Detailed Description
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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. TimePeriod 1 (t1): The reference lung air content will be measured once the asymmetric lung disease is identified on chest x-ray. 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). 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.

Official Title
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Detection of Atelectasis or Pneumothorax and Resolution With Electrical Impedance Tomography (EIT) in Newborn Infants

Conditions
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Atelectasis Neonatal, Pneumothorax and Air Leak

Intervention / Treatment
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* Other: Detecting asymmetric lung disease like atelectasis or pneumothorax with electrical impedance tomography (EIT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All infants admitted to the NICU at SMBHWN Informed consent obtained Atelectasis confirmed on CXR Pneumothorax confirmed on CXR Exclusion Criteria: Declined consent Infants with known congenital anomalies
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Atelectasis or Pneumothorax<br>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)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | % 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electrical Impedance Tomography