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

NCT04848727 | Completed

• 1 other identifier: DePIct
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Atelectasis Neonatal; Pneumothorax and Air Leak

Keywords

Electrical Impedance Tomography

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Geometric Center of Ventilation (CoV)

  Baseline, pre-intervention/procedure/surgery and Immediately after the intervention/procedure/surgery

• Change in % of total tidal volume (VT) within 8 lung regions

  Baseline, pre-intervention/procedure/surgery and Immediately after the intervention/procedure/surgery

• Relative change in uncalibrated aeration (end-expiratory lung volume)

  Baseline, pre-intervention/procedure/surgery and Immediately after the intervention/procedure/surgery

• Regional distribution of tidal volume

  Baseline, pre-intervention/procedure/surgery and Immediately after the intervention/procedure/surgery

• Change in Global Inhomogeneity (GI) index between t1 and t2

  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 Outcomes (3)

• Compare respiratory rate

  Baseline, pre-intervention/procedure/surgery and Immediately after the intervention/procedure/surgery

• 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

  Baseline, pre-intervention/procedure/surgery and Immediately after the intervention/procedure/surgery

Study Arms (1)

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)

Interventions

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.

Atelectasis or Pneumothorax

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• All infants admitted to the NICU at SMBHWN
• Informed consent obtained
• Atelectasis confirmed on CXR
• Pneumothorax confirmed on CXR

You may not qualify if:

• Declined consent
• Infants with known congenital anomalies

Sponsors & Collaborators

• Sharp HealthCare: lead

Study Sites (1)

Sharp Mary Birch Hospital for Women & Newborns

San Diego, California, 92123, United States

Location

Related Publications (4)

• 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: 19255741 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.

  PMID: 27367888 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.

  PMID: 31091957 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.

  PMID: 32884798 BACKGROUND

Related Links

• Design/patents related to the Lumon System

MeSH Terms

Conditions

Pneumothorax

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases

Study Officials

• Anup C Katheria, MD

  Sharp HealthCare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Neonatal Research Institute

Study Record Dates

• First Submitted: April 9, 2021
• First Posted: April 19, 2021
• Study Start: August 6, 2021
• Primary Completion: June 7, 2022
• Study Completion: June 7, 2022
• Last Updated: April 22, 2026

Record last verified: 2026-04

Locations

US (1)