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

To validate the benefits of recognizing asymmetric lung disease like atelectasis and pneumothorax in neonatal respiratory distress syndrome using electrical impedance tomography

Study Overview

• Status: Completed
• Conditions: Atelectasis Neonatal; Pneumothorax and Air Leak
• Intervention / Treatment: Other: Detecting asymmetric lung disease like atelectasis or pneumothorax with electrical impedance tomography (EIT)

Detailed Description

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 clinical therapy (i.e. chest tube placement or needle decompression), whichever occurs first.

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).

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92123
      • Sharp Mary Birch Hospital for Women & Newborns

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

1. All infants admitted to the NICU at SMBHWN
2. Informed consent obtained
3. Atelectasis confirmed on CXR
4. Pneumothorax confirmed on CXR

Exclusion Criteria:

1. Declined consent
2. Infants with known congenital anomalies

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Atelectasis or Pneumothorax; 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.

What is the study measuring?

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
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.

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Sharp HealthCare
• Investigators: Principal Investigator: Anup C Katheria, MD, Sharp HealthCare

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Helpful Links

• Design/patents related to the Lumon System

Study record dates

Study Major Dates

• Study Start (Actual): August 6, 2021
• Primary Completion (Actual): June 7, 2022
• Study Completion (Actual): June 7, 2022

Study Registration Dates

• First Submitted: April 9, 2021
• First Submitted That Met QC Criteria: April 13, 2021
• First Posted (Actual): April 19, 2021

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Electrical Impedance Tomography
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Pleural Diseases; Pneumothorax
• Other Study ID Numbers: DePIct

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No