Clinical trial NCT05612256: Electrical Impedance Tomography for Identification of Optimal Positive End-expiratory Pressure in Newborn Infants
Official title: Electrical Impedance Tomography for Identification of Optimal Positive End-expiratory Pressure in Newborn Infants
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: University Children's Hospital Basel
Sponsor class: OTHER
First posted: 2022-11-10
Enrollment: 86
Sex: ALL
Minimum age (years): 0
Maximum age (years): 28
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed description: Evidence-based guidelines on the optimal level of positive end-expiratory pressure (PEEP) in newborn infants on respiratory support do not exist. Furthermore, there is a lack of simple bed-side parameters to guide clinicians towards the optimal PEEP level. Nevertheless, PEEP requires individual adjustment to minimize ventilator induced lung injury (VILI), shorten the duration of mechanical ventilation and reduce respiratory long-term morbidity.

Potential techniques to assess optimal PEEP level in infants on respiratory support include electrical impedance tomography (EIT), the forced oscillation technique (FOT) and the saturation oxygenation pressure index (SOPI). EIT is a promising non-invasive technique that provides information on regional changes in lung aeration and ventilation inhomogeneity. FOT is used in mechanically ventilated or spontaneously breathing infants and provides information on reactance (Xrs) and resistance (Rrs) of the respiratory system. SOPI is a score calculated from the PEEP level, the amount of administered oxygen (FiO2) and the infant's peripheral oxyhaemoglobin saturation (SpO2). SOPI provides information on the ventilation to perfusion ratio dependent on the PEEP level. EIT, FOT and SOPI seem promising tools for identification of optimal PEEP in newborn infants on respiratory support. In particular, a combination of information on regional ventilation (by EIT), global lung mechanics (by FOT) and ventilation to perfusion ratio (by SOPI) will improve the understanding of optimal PEEP and may reduce long-term respiratory sequelae.

This prospective single-centre observational study is to identify optimal PEEP in infants on respiratory support by measurements of EIT, FOT and SOPI. Measurements are performed once daily during the first three days on respiratory support and are repeated in weekly intervals if the infant remains mechanically ventilated. An additional measurement is planned after extubation.

Eligibility criteria: Inclusion Criteria:

* 22+0 to 41+6 weeks' gestational age
* Requiring mechanical ventilation
* Written informed parental consent

Exclusion Criteria:

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

Primary outcomes:
measure: Change in composite score consisting of proportionally weighted raw values of Silent Spaces, Xrs and SOPI (mechanical ventilation)
timeFrame: Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month)
measure: Change in composite score consisting of proportionally weighted raw values of Silent Spaces and SOPI (non-invasive respiratory support)
timeFrame: Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month)
measure: Change in Silent Spaces (areas of atelectasis as well as overdistension)
timeFrame: Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month)
measure: Change in respiratory reactance (Xrs) (measure of compliance of the respiratory system)
timeFrame: Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month)
measure: Change in Saturation oxygenation pressure index (SOPI)
timeFrame: Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month)
Secondary outcomes:
measure: Change in Delta impedance (ΔZ)
timeFrame: Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month)
measure: Change in centre of ventilation (CoV)
timeFrame: Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month)
measure: Change in tidal volume (VT,EIT)
timeFrame: Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month)
measure: Change in driving pressure of the respiratory system (Peak plateau pressure - PEEP)
timeFrame: Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month)
measure: Change in resistance (Rrs) of the respiratory system
timeFrame: Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month)
measure: Change in peak inspiratory pressure
timeFrame: Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month)
measure: Change in tidal volume per kg body weight (VT/kg)
timeFrame: Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month)
measure: Change in dynamic compliance
timeFrame: Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month)
measure: Change in respiratory rate
timeFrame: Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month)
measure: Change in transcutaneous CO2 pressure (tcpCO2)
timeFrame: Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month)
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Department of Neonatology, University Children's Hospital Basel UKBB
Study officials:
affiliation: Department of Neonatology, University Children's Hospital Basel UKBB
name: Roland Gerull, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: