Pulmonary Volume Changes During Synchonized Noninvasive Positive Pressure Ventilation

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 4
SponsorUniversity of Zurich

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Severe congenital malformation adversely affecting lung aeration or perfusion (e.g., congenital heart defects)

Too ill/unstable in the opinion of the treating physician.

Trial population

This study will take place at the Department of Neonatology of the University Hospital Zurich. Preterm infants on a synchronized mode of non-invasive positive pressure ventilation will be screened for eligibility and parents will be approached by the treating physician or a clinician-researcher who is authorized to access the patient's clinical data.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Electrical Impedance Tomography (EIT)

    Device

    Electrical Impedance Tomography and clinical data will be recorded continuously. Corresponding data will be extracted and analyzed at five pre-defined timepoints.

Treatment groups

27 Participants
are divided into 1 treatment group
Group A: Preterm infants with a gestational age < 30 0/7 weeks at birth1 intervention

Trial outcomes

Primary outcomes

1

Tidal volume (VT)

Difference in relative VT (rel. ΔZ) between spontaneous breaths and synchronized inflations.

Time frame
At five pre-defined timepoints from the beginning to the end of the study at 180 minutes.

Secondary outcomes

1

Global lung impedance

Difference between end-expiratory lung impedance (EELI) and inspiratory onset lung impedance (SILI) during spontaneous breaths, synchronized inflations, non-synchronized inflations, and back-up inflations.

Time frame
At five pre-defined timepoints from the beginning to the end of the study at 180 minutes.
2

Regional tidal volume distribution

Difference in regional tidal distribution between spontaneous breaths, synchronized inflations, non-synchronized inflations and back-up inflations

Time frame
At five pre-defined timepoints from the beginning to the end of the study at 180 minutes.
3

Center of ventilation

Difference in center of ventilation between spontaneous breaths, synchronized inflations, non-synchronized inflations and back-up inflations

Time frame
At five pre-defined timepoints from the beginning to the end of the study at 180 minutes.
4

Silent spaces

Difference in silent spaces between spontaneous breaths, synchronized inflations, non-synchronized inflations and back-up inflations

Time frame
At five pre-defined timepoints from the beginning to the end of the study at 180 minutes.

Other outcomes

Sponsors and contacts

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University of Zurich

Lead sponsor

University Hospital, Zürich

Collaborator