Comparison of Computertomography Scan, Electrical Impedance Tomography, and Ultrasound of the Lung in Infants

NCT ID: NCT04989439

Last Updated: 2024-11-20

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-07-19
• Study Completion Date: 2025-12-31

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.

Detailed Description

Lung imaging has become increasingly important across medical specialties for diagnostic, monitoring, and investigative purposes in acute respiratory distress syndrome (ARDS). Lung computer tomography (CT) is the gold standard chest imaging technique to evaluate lung morphology and to perform a quantitative analysis of lung tissue aeration and recruitment. In the last decades, electrical impedance tomography (EIT) has gained a lot of attention in monitoring functional lung parameters. EIT is a non-invasive, bedside radiation-free functional imaging modality for continuous monitoring of lung ventilation and perfusion. Functional chest examinations with EIT are considered clinically relevant, especially for monitoring regional lung ventilation in patients with respiratory support, but also to assess aeration in preterm and term infants. In comparison with dynamic CT, EIT proved to be useful in bedside adjustments of mechanical ventilation with immediate feedback in adult patients. EIT lacks the spatial resolution of other imaging modalities but it is compact in size, uses no ionizing radiation, and gives functional images with high temporal resolution. As CT scans expose patients to ionizing radiation, there are no investigative studies comparing EIT with CT scans in newborns and infants. This would be useful, particularly, for correlating the reference impedance image with a CT scan to correctly calibrate anatomical structures and to differentiate between dependent and non-dependent lung areas. Likewise, lung ultrasound (LUS) has been increasingly used for the diagnosis of different lung conditions. Some validation studies compared LUS with CT scans and classified LUS to be a valid tool to assess regional and global lung aeration also in newborns. To our knowledge, there are no comparative studies between EIT and LUS in newborns and infants.

The main objective is to compare different lung imaging modalities in infants with and without lung disease using the CT scan as reference method. The study focuses on regional lung examination. 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 this group of patients.

The CT scan is part of the routine care of the participants. No additional CT examinations will be performed for this study. LUS and EIT will be performed immediately before or after the planned CT scan. Both LUS and EIT measurements will be performed with mobile devices and will take approximately 20 minutes.

Conditions

Infant ALL; Computed Tomography; Electric Impedance; Ultrasonography; Lung Injury

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Electrical impedance tomography and ultrasonography of the lung

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Maximum Eligible Age: 12 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Tobias Werther

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tobias Werther, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Locations

Medical University of Vienna

Vienna, , Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Tobias Werther, MD, PhD

Role: CONTACT

tobias.werther@meduniwien.ac.at

+4314040032320

Facility Contacts

Tobias Werther, MD, PhD

Role: primary

tobias.werther@meduniwien.ac.at

+43014040032320

References

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.

Reference Type: BACKGROUND

PMID: 27033882 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28828369 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17468568 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30048331 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22343863 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27596161 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 14693669 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23474677 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22202705 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30127522 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25341049 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32728966 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29516865 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19491438 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26237465 (View on PubMed)

Other Identifiers

1565/2021

Identifier Type: -

Identifier Source: org_study_id