Pulmonary Volume Changes During Synchonized Noninvasive Positive Pressure Ventilation

Not yet recruiting

• Conditions: Infant, Preterm; Respiratory Distress Syndrome (Neonatal); Chronic Lung Disease of Newborn; Respiratory Support; Lung Volume; Synchronized Noninvasive Positive Pressure Ventilation (SNIPPV)

• Registration Number: NCT07237139
• Lead Sponsor: University of Zurich

Brief Summary

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.

Detailed Description

Hypothesis:

We hypothesize that 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).

1. 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.

2. 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.

3. 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) .

4. 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.

Study Timeline

• Status Verified: 2025-11
• Study Start: 2025-11-14
• Study First Submitted: 2025-11-14
• Study First Submitted QC: 2025-11-14
• Last Update Submitted: 2025-11-14
• Study First Posted: 2025-11-19
• Last Update Posted: 2025-11-19
• Primary Completion: 2026-12-31
• Study Completion: 2027-01-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 27

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tidal volume (VT)	At five pre-defined timepoints from the beginning to the end of the study at 180 minutes.	Difference in relative VT (rel. ΔZ) between spontaneous breaths and synchronized inflations.

Secondary Outcome Measures

Name	Time	Method
Regional tidal volume distribution	At five pre-defined timepoints from the beginning to the end of the study at 180 minutes.	Difference in regional tidal distribution between spontaneous breaths, synchronized inflations, non-synchronized inflations and back-up inflations
Global lung impedance	At five pre-defined timepoints from the beginning to the end of the study at 180 minutes.	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.
Silent spaces	At five pre-defined timepoints from the beginning to the end of the study at 180 minutes.	Difference in silent spaces between spontaneous breaths, synchronized inflations, non-synchronized inflations and back-up inflations
Center of ventilation	At five pre-defined timepoints from the beginning to the end of the study at 180 minutes.	Difference in center of ventilation between spontaneous breaths, synchronized inflations, non-synchronized inflations and back-up inflations
Global inhomogeneity index	At five pre-defined timepoints from the beginning to the end of the study at 180 minutes.	Difference in global inhomogeneity index between spontaneous breaths, synchronized inflations, non-synchronized inflations and back-up inflations
Coefficient of variation	At five pre-defined timepoints from the beginning to the end of the study at 180 minutes.	Difference in coefficient of variation (EIT) between spontaneous breaths, synchronized inflations, non-synchronized inflations and back-up inflations
Inspiratory time	At five pre-defined timepoints from the beginning to the end of the study at 180 minutes.	Difference in inspiratory times between spontaneous breaths, synchronized inflations, non-synchronized inflations and back-up inflations
Expiratory time	At five pre-defined timepoints from the beginning to the end of the study at 180 minutes.	Difference in expiratory times between spontaneous breaths, synchronized inflations, non-synchronized inflations and back-up inflations
Lung ultrasound score	Immediately before the first infant handling as well as following electrical impedance tomography belt removal.	Difference in lung ultrasound score at two pre-defined timepoints.
Heart rate	Continuous measurement during the 180-minute recording period.	Changes of heart rate between five pre-defined time points.
Peripheral oxygen saturation	Continuous measurement during the 180-minute recording period.	Changes in oxygen saturation between five pre-defined time points.
Oxygen supplementation	Continuous measurement during the 180-minute recording period.	Changes in FiO2 between five pre-defined time points.

Trial Locations

Locations (1)

University Hospital Zurich; 🇨🇭 Zurich, Canton of Zurich, Switzerland