Pulmonary Volume Changes During Synchonized Noninvasive Positive Pressure Ventilation (INSPIRE)

University of Zurich (UZH)

Status

Enrolling

Conditions

Lung Volume

Chronic Lung Disease of Newborn

Respiratory Support

Respiratory Distress Syndrome (Neonatal)

Synchronized Noninvasive Positive Pressure Ventilation (SNIPPV)

Infant, Preterm

Treatments

Device: Electrical Impedance Tomography (EIT)

Study type

Observational

Funder types

Other

Identifiers

NCT07237139

INSPIRE

Details and patient eligibility

About

Current evidence suggests that noninvasive positive pressure ventilation (NIPPV) is more effective than continuous positive airway pressure (CPAP) in preventing respiratory failure in preterm infants with respiratory distress syndrome (RDS), both as initial and post-extubation support. NIPPV may be delivered in synchronized (sNIPPV) or non-synchronized (nsNIPPV) modes, with sNIPPV offering clear benefits by coordinating support with the infant's own breathing. Recent studies indicate sNIPPV is superior to nsNIPPV in preventing respiratory failure, though the intrapulmonary mechanisms behind this advantage remain unclear. To address this, the present study uses Electrical Impedance Tomography (EIT) to evaluate how lung volume changes during different types of breaths and ventilator inflations - spontaneous breaths, synchronized inflations, non-synchronized inflations, and backup inflations - in preterm infants receiving sNIPPV.

Full description

Hypothesis:

Synchronized inflations during NIPPV will increase tidal volumes (VT) and lung aeration when compared with non-synchronized inflations. Pressure peaks delivered during expiration (non-synchronized inflations), between spontaneous breaths (backup inflations), or during periods of apnea (backup inflations) will not increase relative VT.

Primary objective:

The primary objective is to assess lung volume changes between spontaneous breaths and synchronized inflations, non-synchronized inflations, and backup inflations using EIT.

Secondary objectives:

The secondary objectives are to assess regional differences in aeration and ventilation among spontaneous breaths, synchronized inflations, non-synchronized inflations, and backup inflations using EIT.

Primary endpoint:

Difference in relative Vt (rel. Delta-Z) between spontaneous breaths and synchronized inflations.

Study procedures:

Study procedures include attaching an EIT belt and a pulse oximeter sensor during the final nursing care session before the study begins. Synchronized NIPPV is provided by EVEneo ventilators, and synchronization will be achieved through an abdominal capsule (Graseby).

Sixty minutes after the beginning of the EIT recording , the noninvasve ventilation mode will be switched to CPAP for 2 minutes. This 2-minute period will be the baseline period during which spontaneous breathing will be assessed.
The NIV mode will then be switched back to sNIPPV. Ventilator settings will be maintained at the same levels used before the start of the study, and adjustments will not be permitted.
Prior to the next nursing care session, a second 2-minute nCPAP period will be introduced and serve as the baseline (together with the 1st CPAP period) .
The EIT recording and SpO2/HR measurements will continue until the next nursing care round, at which point the EIT belt and SpO2 sensor will be removed.

Enrollment

27 estimated patients

Sex

All

Ages

Under 4 weeks old

Volunteers

No Healthy Volunteers

Inclusion criteria

Written informed consent by one or both parents or legal guardians
Gestational age at birth < 30 0/7 weeks
Infants on sNIPPV respiratory support
Below 4 weeks chronological age

Exclusion criteria

Severe congenital malformation adversely affecting lung aeration or perfusion (e.g., congenital heart defects)
Too ill/unstable in the opinion of the treating physician.