NCT04989439

Brief Summary

The study focuses on regional lung examination, in particular on the differentiation between collapsed and hyperinflated lung areas. The purpose of the study is to elaborate common and discriminative elements between different lung imaging modalities in infants and to generate hypotheses for the bedside use of EIT and LUS in infants.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 19, 2021

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

July 25, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 4, 2021

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

November 20, 2024

Status Verified

November 1, 2024

Enrollment Period

4 years

First QC Date

July 25, 2021

Last Update Submit

November 18, 2024

Conditions

Infant ALLComputed TomographyElectric ImpedanceUltrasonographyLung Injury

Keywords

CT, electrical impedance tomography, ultrasound

Outcome Measures

Primary Outcomes (2)

  • Comparison between CT and EIT

    Estimate difference of lung cross-section between CT scan and EIT

    through study completion, an average of 1 year

  • Comparison between CT and LUS

    Comparison of diagnosis (presence of pathologic patterns including pneumothorax, emphysema, atelectasis, consolidation, ground glass opacity, bronchial wall thickening and/or dilatation) in CT and LUS

    through study completion, an average of 1 year

Secondary Outcomes (1)

  • Comparison between EIT and LUS

    through study completion, an average of 1 year

Interventions

Electrical impedance tomography and ultrasonography of the lungOTHER

Both EIT and LUS are non-invasive methods and do not pose any additional risk for the patient. The LuMon System with pediatric EIT belts (LuMon Belt, Sentec, Landquart, Switzerland) will be used. The belt will be placed on the thorax circumference of the infant and connected to the LuMonConnector (Sentec, Landquart, Switzerland). Small electrical currents (3 mA, 198 kHz) will be repetitively injected in rotation through adjacent electrode pairs, and voltage changes will be measured by all passive electrodes pairs (scan rate 48 Hz). Changes in lung electrical impedance will be continuously recorded for 5 minutes. EIT data will be analyzed off-line using Matlab (Mathworks, Natick, Massachusetts, USA). The regional tidal volume distribution, the homogeneity of tidal ventilation distribution, regional respiratory system compliance, and alveolar overdistension and collapse will be assessed. LUS will be performed by experienced users, with a 10 MHz linear transducer.

Eligibility Criteria

AgeUp to 12 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Infants receiving a CT scan of the thorax.

You may qualify if:

  • Patients hospitalized at the Department of Pediatrics of the Medical University of Vienna who will get a CT scan of the thorax.
  • Patients aged up to 12 months

You may not qualify if:

  • Unstable cardiovascular, respiratory and/or neurological conditions.
  • Sternotomy during the previous 15 days.
  • Thoracic skin lesions or wounds (including burns) on the thorax, where the EIT-electrode-belt would be placed.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

Related Publications (15)

  • Pesenti A, Musch G, Lichtenstein D, Mojoli F, Amato MBP, Cinnella G, Gattinoni L, Quintel M. Imaging in acute respiratory distress syndrome. Intensive Care Med. 2016 May;42(5):686-698. doi: 10.1007/s00134-016-4328-1. Epub 2016 Mar 31.

    PMID: 27033882BACKGROUND

  • Ball L, Vercesi V, Costantino F, Chandrapatham K, Pelosi P. Lung imaging: how to get better look inside the lung. Ann Transl Med. 2017 Jul;5(14):294. doi: 10.21037/atm.2017.07.20.

    PMID: 28828369BACKGROUND

  • Caironi P, Gattinoni L. How to monitor lung recruitment in patients with acute lung injury. Curr Opin Crit Care. 2007 Jun;13(3):338-43. doi: 10.1097/MCC.0b013e32814db80c.

    PMID: 17468568BACKGROUND

  • Chiumello D, Mongodi S, Algieri I, Vergani GL, Orlando A, Via G, Crimella F, Cressoni M, Mojoli F. Assessment of Lung Aeration and Recruitment by CT Scan and Ultrasound in Acute Respiratory Distress Syndrome Patients. Crit Care Med. 2018 Nov;46(11):1761-1768. doi: 10.1097/CCM.0000000000003340.

    PMID: 30048331BACKGROUND

  • Frerichs I, Weiler N. Electrical impedance tomography: the next game level*. Crit Care Med. 2012 Mar;40(3):1015-6. doi: 10.1097/CCM.0b013e31823d7849. No abstract available.

    PMID: 22343863BACKGROUND

  • Frerichs I, Amato MB, van Kaam AH, Tingay DG, Zhao Z, Grychtol B, Bodenstein M, Gagnon H, Bohm SH, Teschner E, Stenqvist O, Mauri T, Torsani V, Camporota L, Schibler A, Wolf GK, Gommers D, Leonhardt S, Adler A; TREND study group. Chest electrical impedance tomography examination, data analysis, terminology, clinical use and recommendations: consensus statement of the TRanslational EIT developmeNt stuDy group. Thorax. 2017 Jan;72(1):83-93. doi: 10.1136/thoraxjnl-2016-208357. Epub 2016 Sep 5.

    PMID: 27596161BACKGROUND

  • Victorino JA, Borges JB, Okamoto VN, Matos GF, Tucci MR, Caramez MP, Tanaka H, Sipmann FS, Santos DC, Barbas CS, Carvalho CR, Amato MB. Imbalances in regional lung ventilation: a validation study on electrical impedance tomography. Am J Respir Crit Care Med. 2004 Apr 1;169(7):791-800. doi: 10.1164/rccm.200301-133OC. Epub 2003 Dec 23.

    PMID: 14693669BACKGROUND

  • Wolf GK, Gomez-Laberge C, Rettig JS, Vargas SO, Smallwood CD, Prabhu SP, Vitali SH, Zurakowski D, Arnold JH. Mechanical ventilation guided by electrical impedance tomography in experimental acute lung injury. Crit Care Med. 2013 May;41(5):1296-304. doi: 10.1097/CCM.0b013e3182771516.

    PMID: 23474677BACKGROUND

  • Muders T, Luepschen H, Zinserling J, Greschus S, Fimmers R, Guenther U, Buchwald M, Grigutsch D, Leonhardt S, Putensen C, Wrigge H. Tidal recruitment assessed by electrical impedance tomography and computed tomography in a porcine model of lung injury*. Crit Care Med. 2012 Mar;40(3):903-11. doi: 10.1097/CCM.0b013e318236f452.

    PMID: 22202705BACKGROUND

  • Raimondi F, Yousef N, Migliaro F, Capasso L, De Luca D. Point-of-care lung ultrasound in neonatology: classification into descriptive and functional applications. Pediatr Res. 2021 Sep;90(3):524-531. doi: 10.1038/s41390-018-0114-9. Epub 2018 Jul 20.

    PMID: 30127522BACKGROUND

  • Liu J, Chen SW, Liu F, Li QP, Kong XY, Feng ZC. The diagnosis of neonatal pulmonary atelectasis using lung ultrasonography. Chest. 2015 Apr;147(4):1013-1019. doi: 10.1378/chest.14-1306.

    PMID: 25341049BACKGROUND

  • Zieleskiewicz L, Markarian T, Lopez A, Taguet C, Mohammedi N, Boucekine M, Baumstarck K, Besch G, Mathon G, Duclos G, Bouvet L, Michelet P, Allaouchiche B, Chaumoitre K, Di Bisceglie M, Leone M; AZUREA Network. Comparative study of lung ultrasound and chest computed tomography scan in the assessment of severity of confirmed COVID-19 pneumonia. Intensive Care Med. 2020 Sep;46(9):1707-1713. doi: 10.1007/s00134-020-06186-0. Epub 2020 Jul 29.

    PMID: 32728966BACKGROUND

  • Sophocleous L, Frerichs I, Miedema M, Kallio M, Papadouri T, Karaoli C, Becher T, Tingay DG, van Kaam AH, Bayford R, Waldmann AD. Clinical performance of a novel textile interface for neonatal chest electrical impedance tomography. Physiol Meas. 2018 Apr 26;39(4):044004. doi: 10.1088/1361-6579/aab513.

    PMID: 29516865BACKGROUND

  • Adler A, Arnold JH, Bayford R, Borsic A, Brown B, Dixon P, Faes TJ, Frerichs I, Gagnon H, Garber Y, Grychtol B, Hahn G, Lionheart WR, Malik A, Patterson RP, Stocks J, Tizzard A, Weiler N, Wolf GK. GREIT: a unified approach to 2D linear EIT reconstruction of lung images. Physiol Meas. 2009 Jun;30(6):S35-55. doi: 10.1088/0967-3334/30/6/S03. Epub 2009 Jun 2.

    PMID: 19491438BACKGROUND

  • Brat R, Yousef N, Klifa R, Reynaud S, Shankar Aguilera S, De Luca D. Lung Ultrasonography Score to Evaluate Oxygenation and Surfactant Need in Neonates Treated With Continuous Positive Airway Pressure. JAMA Pediatr. 2015 Aug;169(8):e151797. doi: 10.1001/jamapediatrics.2015.1797. Epub 2015 Aug 3.

    PMID: 26237465BACKGROUND

MeSH Terms

Conditions

Lung Injury

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesThoracic InjuriesWounds and Injuries

Study Officials

  • Tobias Werther, MD, PhD

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tobias Werther, MD, PhD

CONTACT

+4314040032320tobias.werther@meduniwien.ac.at

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 25, 2021

First Posted

August 4, 2021

Study Start

July 19, 2021

Primary Completion

July 31, 2025

Study Completion

December 31, 2025

Last Updated

November 20, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)