Electrical Impedance Tomography for Identification of Optimal Positive End-expiratory Pressure in Newborn Infants
- Conditions
- Positive End-expiratory Pressure (PEEP)
- Interventions
- Diagnostic Test: Electrical impedance tomography (EIT)Diagnostic Test: Saturation oxygenation pressure index (SOPI)Diagnostic Test: Forced oscillation technique (FOT)
- Registration Number
- NCT05612256
- Lead Sponsor
- University Children's Hospital Basel
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 86
- 22+0 to 41+6 weeks' gestational age
- Requiring mechanical ventilation
- Written informed parental consent
- Major congenital malformations including lung and cardiac malformations
- Infants on high frequency oscillatory ventilation
- Lack of written informed parental consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Infants on mechanical ventilation Electrical impedance tomography (EIT) - Infants on non-invasive respiratory support Saturation oxygenation pressure index (SOPI) - Infants on mechanical ventilation Forced oscillation technique (FOT) - Infants on non-invasive respiratory support Electrical impedance tomography (EIT) - Infants on mechanical ventilation Saturation oxygenation pressure index (SOPI) -
- Primary Outcome Measures
Name Time Method Change in Silent Spaces (areas of atelectasis as well as overdistension) Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month) Silent Spaces measured by EIT (calculated from electrical impedance)
Change in composite score consisting of proportionally weighted raw values of Silent Spaces, 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) A composite score consisting of proportionally weighted raw values of Silent Spaces, respiratory reactance (Xrs) and SOPI (mechanical ventilation)
Change in Saturation oxygenation pressure index (SOPI) Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month) 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)
Change in 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) A composite score consisting of proportionally weighted raw values of Silent Spaces and SOPI (non-invasive respiratory support)
Change in respiratory reactance (Xrs) (measure of compliance 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) Respiratory reactance reflects inertance and compliance of the lungs and can be viewed as rebound resistance
- Secondary Outcome Measures
Name Time Method 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) Resistance (Rrs) is an additional FOT parameter
Change in tidal volume per kg body weight (VT/kg) Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month) Tidal volume per kg body weight (VT/kg) is a mechanical ventilation parameters
Change in dynamic compliance Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month) Dynamic compliance is a mechanical ventilation parameters
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) Delta impedance (ΔZ) is an additional EIT parameter
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) Centre of ventilation (CoV) is an additional EIT parameter
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) Tidal volume (VT,EIT) is an additional EIT parameter
Change in transcutaneous CO2 pressure (tcpCO2) Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month) Change in peak inspiratory pressure Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month) Peak inspiratory pressure is a mechanical ventilation parameters
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 respiratory rate Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month) Respiratory rate is a mechanical ventilation parameters
Trial Locations
- Locations (1)
Department of Neonatology, University Children's Hospital Basel UKBB
🇨🇭Basel, Switzerland