Electrical Impedance Tomography for Identification of Optimal Positive End-expiratory Pressure in Newborn Infants

NCT05612256 | Recruiting

• 1 other identifier: 2022-00508; ks22Gerull
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

Electrical impedance tomography (EIT) enables assessment of regional lung ventilation at the bedside. EIT has been safely used in newborn infants to image intrathoracic lung volume patterns as early as from the first minute of life. This prospective single-centre observational study is to identify optimal PEEP in infants on respiratory support by measurements of EIT, FOT and SOPI.

Conditions

Positive End-expiratory Pressure (PEEP)

Keywords

respiratory support; newborn infants; ventilator induced lung injury (VILI); mechanical ventilation; electrical impedance tomography (EIT); forced oscillation technique (FOT); saturation oxygenation pressure index (SOPI); ventilation to perfusion ratio; regional lung ventilation patterns; Silent Spaces

Outcome Measures

Primary Outcomes (5)

• Change in composite score consisting of proportionally weighted raw values of Silent Spaces, Xrs and SOPI (mechanical ventilation)

  A composite score consisting of proportionally weighted raw values of Silent Spaces, respiratory reactance (Xrs) and SOPI (mechanical ventilation)

  Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month)

• Change in composite score consisting of proportionally weighted raw values of Silent Spaces and SOPI (non-invasive respiratory support)

  A composite score consisting of proportionally weighted raw values of Silent Spaces and SOPI (non-invasive respiratory support)

  Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month)

• Change in Silent Spaces (areas of atelectasis as well as overdistension)

  Silent Spaces measured by EIT (calculated from electrical impedance)

  Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month)

• Change in respiratory reactance (Xrs) (measure of compliance of the respiratory system)

  Respiratory reactance reflects inertance and compliance of the lungs and can be viewed as rebound resistance

  Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month)

• Change in Saturation oxygenation pressure index (SOPI)

  Calculated from standard monitoring parameters such as PEEP, fraction of inspired oxygen pressure (FiO2) and peripheral oxyhaemoglobin saturation (SpO2) (PEEP x FiO2 x 100) / SpO2)

  Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month)

Secondary Outcomes (10)

• Change in Delta impedance (ΔZ)

  Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month)

• Change in centre of ventilation (CoV)

  Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month)

• Change in tidal volume (VT,EIT)

  Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month)

• Change in driving pressure of the respiratory system (Peak plateau pressure - PEEP)

  Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month)

• Change in resistance (Rrs) of the respiratory system

  Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month)

Study Arms (2)

Infants on mechanical ventilation

Diagnostic Test: Electrical impedance tomography (EIT); Diagnostic Test: Forced oscillation technique (FOT); Diagnostic Test: Saturation oxygenation pressure index (SOPI)

Infants on non-invasive respiratory support

Diagnostic Test: Electrical impedance tomography (EIT); Diagnostic Test: Saturation oxygenation pressure index (SOPI)

Interventions

Electrical impedance tomography (EIT) DIAGNOSTIC_TEST

EIT is the measurement of impedance changes of the lung against the flow of alternating electrical currents applied to the thorax. The signal of the electrodes is transmitted to a monitor, which enables real-time assessment of lung aeration and changes in lung volume. EIT is able to reconstruct impedance changes with a high temporal resolution and allows calculation of tidal volumes, relative stretch of lung tissue and areas of poor ventilation. Areas with impedance changes of \< 10 % of the maximum impedance changes are called 'Silent Spaces'.

Infants on mechanical ventilation; Infants on non-invasive respiratory support

Forced oscillation technique (FOT) DIAGNOSTIC_TEST

FOT enables non-invasive assessment of lung mechanics using sound waves to inform about the respiratory impedance of the respiratory system (Zrs). Reactance of the respiratory system (Xrs) as part of Zrs is a surrogate measure of compliance of the respiratory system. Xrs was previously used to identify optimal PEEP level, i.e., the PEEP at highest compliance equivalent, in newborn infants using a setup requiring research-specific hardware and software. The FOT module integrated in the commercially available neonatal ventilator is routinely used. FOT measurements are performed twice at each PEEP level to assess the reproducibility of the measurements.

Infants on mechanical ventilation

Saturation oxygenation pressure index (SOPI) DIAGNOSTIC_TEST

SOPI is assessed non-invasively and calculated from standard monitoring parameters such as PEEP, fraction of inspired oxygen pressure (FiO2) and peripheral oxyhaemoglobin saturation (SpO2) (PEEP x FiO2 x 100) / SpO2). SOPI is used to provide information on ventilation to perfusion ratio dependent on PEEP level.

Infants on mechanical ventilation; Infants on non-invasive respiratory support

Eligibility Criteria

• Age: 0 Days - 28 Days
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

All newborn infants admitted to the University Children's Hospital Basel UKBB requiring mechanical ventilation are eligible for the study.

You may qualify if:

• +0 to 41+6 weeks' gestational age
• Requiring mechanical ventilation
• Written informed parental consent

You may not qualify if:

• Major congenital malformations including lung and cardiac malformations
• Infants on high frequency oscillatory ventilation
• Lack of written informed parental consent

Sponsors & Collaborators

• University Children's Hospital Basel: lead

Study Sites (1)

Department of Neonatology, University Children's Hospital Basel UKBB

Basel, 4031, Switzerland

RECRUITING

MeSH Terms

Conditions

Ventilator-Induced Lung Injury

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Roland Gerull, Dr. med.

  Department of Neonatology, University Children's Hospital Basel UKBB

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roland Gerull, Dr. med.

CONTACT

+41 61 70 42 307; Roland.Gerull@ukbb.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2022
• First Posted: November 10, 2022
• Study Start: December 10, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 9, 2024

Record last verified: 2024-12

Locations

CH (1)