Atelectasis NeonatalDePIcTNCT04848727
Detection of Atelectasis or Pneumothorax and Resolution With Electrical Impedance Tomography (EIT) in Newborn Infants
An observational study of Atelectasis Neonatal and Pneumothorax and Air Leak, run by Sharp HealthCare at 1 site in United States.
Trial summary
To validate the benefits of recognizing asymmetric lung disease like atelectasis and pneumothorax in neonatal respiratory distress syndrome using electrical impedance tomography Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atelectasis Neonatal, Pneumothorax and Air Leak
- What is being tested?
- Detecting asymmetric lung disease like atelectasis or pneumothorax with electrical impedance tomography (EIT)
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Aug 2021to 7 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- All infants admitted to the NICU at SMBHWN
- Informed consent obtained
- Atelectasis confirmed on CXR
- Pneumothorax confirmed on CXR
Who cannot join
- Declined consent
- Infants with known congenital anomalies
Trial locations and contacts
1 site in 1 country.
United States1 site
Sharp Mary Birch Hospital for Women & Newborns
San Diego, California, 92123
About this study
To validate the benefits of recognizing asymmetric lung disease like atelectasis and pneumothorax in neonatal respiratory distress syndrome using electrical impedance tomography
Read the 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).
- Conditions
- Atelectasis Neonatal, Pneumothorax and Air Leak
- Being tested
- Detecting asymmetric lung disease like atelectasis or pneumothorax with electrical impedance tomography (EIT)
- Keywords
- Electrical Impedance Tomography
- Medical subject headings
- Pneumothorax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Atelectasis or Pneumothorax | Infants with asymmetric lung disease (i.e. atelectasis or pneumothorax) confirmed by chest radiograph Receives: Other: Detecting asymmetric lung disease like atelectasis or pneumothorax with electrical impedance tomography (EIT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: Baseline, pre-intervention/procedure/surgery and Immediately after the intervention/procedure/surgery
Secondary outcomes (5)
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start6 Aug 2021
- Primary completion7 Jun 2022
- Study completion7 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Atelectasis NeonatalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sharp HealthCare
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anup Katheria, M.D., Sharp HealthCare
- Investigators
- Anup C Katheria, MD, Principal investigator, Sharp HealthCare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04848727
- Sponsor's protocol ID
- DePIct
- Acronym
- DePIcT
- Status last verified
- Apr 2026
- First submitted
- 9 Apr 2021
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 19255741Miedema 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.
PubMed 27367888Rahtu 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.
PubMed 31091957Kallio 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.
PubMed 32884798
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Atelectasis or Pneumothorax and Resolution With Electrical Impedance Tomography (EIT) in Newborn Infants
- ClinicalTrials.gov ID
- NCT04848727
- Acronym / sponsor ID
- DePIcT / DePIct
- Conditions
- Atelectasis Neonatal, Pneumothorax and Air Leak
- Keywords
- Electrical Impedance Tomography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Sharp HealthCareUniversity, hospital or other
- Study start
- 6 Aug 2021 (actual)
- Primary completion
- 7 Jun 2022 (actual)
- Study completion
- 7 Jun 2022 (actual)
- First posted
- 19 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To validate the benefits of recognizing asymmetric lung disease like atelectasis and pneumothorax in neonatal respiratory distress syndrome using electrical impedance tomography
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Atelectasis or Pneumothorax | – | Other: Detecting asymmetric lung disease like atelectasis or pneumothorax with electrical impedance tomography (EIT)Infants with asymmetric lung disease (i.e. atelectasis or pneumothorax) confirmed by chest radiograph |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- All infants admitted to the NICU at SMBHWN
- Informed consent obtained
- Atelectasis confirmed on CXR
- Pneumothorax confirmed on CXR
Key exclusion criteria (2 listed)
- Declined consent
- Infants with known congenital anomalies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Atelectasis or Pneumothorax |
Primary outcome
Atelectasis: Change in measured % Unventilated Lung between TimePeriods (t1 and t2)
Time frame: Baseline, pre-intervention/procedure/surgery and Immediately after the intervention/procedure/surgery
Atelectasis will be calculated using the percentage of the lung fields that are not engaged in tidal volume.(VT)
Pneumothorax: Change in measured % Unventilated Lung between TimePeriods (t1 and t2)
Time frame: Baseline, pre-intervention/procedure/surgery and Immediately after the intervention/procedure/surgery
To determine pneumothorax is the percentage of lung areas with non-negligible impedance change during breathing.
5 secondary outcomes
Geometric Center of Ventilation (CoV)
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
Time frame: Baseline, pre-intervention/procedure/surgery and Immediately after the intervention/procedure/surgery
Relative change in uncalibrated aeration (end-expiratory lung volume)
Time frame: Baseline, pre-intervention/procedure/surgery and Immediately after the intervention/procedure/surgery
Regional distribution of tidal volume
Time frame: Baseline, pre-intervention/procedure/surgery and Immediately after the intervention/procedure/surgery
Change in Global Inhomogeneity (GI) index between t1 and t2
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Background: PubMed 19255741Costa 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.
- Background: PubMed 27367888Miedema 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.
- Background: PubMed 31091957Rahtu 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.
- Background: PubMed 32884798Kallio 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.
- Design/patents related to the Lumon SystemLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anup C Katheria, MD principal investigator
Sharp HealthCare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atelectasis Neonatal and Pneumothorax and Air Leak, run by Sharp HealthCare at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Atelectasis: Change in measured % Unventilated Lung between TimePeriods (t1 and t2) (time frame: Baseline, pre-intervention/procedure/surgery and Immediately after the intervention/procedure/surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04848727, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.