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

University Children's Hospital Basel

Status: Enrolling

Conditions: Positive End-expiratory Pressure (PEEP)

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

Study type: Observational

Funder types: Other

Identifiers

NCT05612256

2022-00508 ks22Gerull;

Details and patient eligibility

About

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.

Full 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.

Enrollment: 86 estimated patients

Sex: All

Ages: Under 28 days old

Volunteers: No Healthy Volunteers

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

Trial design

86 participants in 2 patient groups

Infants on mechanical ventilation

Treatment:

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

Treatment:

Diagnostic Test: Electrical impedance tomography (EIT)

Diagnostic Test: Saturation oxygenation pressure index (SOPI)