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Pulmonary Volume Changes During Synchonized Noninvasive Positive Pressure Ventilation

Intrapulmonary Volume Changes During Synchronized Noninvasive Positive Pressure Ventilation In Preterm Infants

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07237139
Acronym
INSPIRE
Enrollment
27
Registered
2025-11-19
Start date
2025-11-17
Completion date
2027-01-30
Last updated
2025-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Synchronized noninvasive positive pressure ventilation (SNIPPV), Lung volume, Electrical Impedance Tomography (EIT), infant, preterm

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: 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.

Interventions

DEVICEElectrical Impedance Tomography (EIT)

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

Sponsors

University Hospital, Zürich
CollaboratorOTHER
University of Zurich
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 4 Weeks
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
Regional tidal volume distributionAt 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
Center of ventilationAt 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
Silent spacesAt 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
Global inhomogeneity indexAt 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. An inhomogeneity index of zero represents a perfectly homogeneous distribution of ventilation.
Coefficient of variationAt 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
Global lung impedanceAt 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.
Expiratory timeAt 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 scoreImmediately before the first infant handling as well as following electrical impedance tomography belt removal.Difference in lung ultrasound score at two pre-defined timepoints. Each lung will be divided into 3 areas. For each lung area, a 0- to 3-point score will be given (total score ranging from 0-18). Higher scores represent greater severity of lung disease.
Heart rateContinuous measurement during the 180-minute recording period.Changes of heart rate between five pre-defined time points.
Peripheral oxygen saturationContinuous measurement during the 180-minute recording period.Changes in oxygen saturation between five pre-defined time points.
Oxygen supplementationContinuous measurement during the 180-minute recording period.Changes in FiO2 between five pre-defined time points.
Inspiratory timeAt 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

Countries

Switzerland

Contacts

Primary ContactChristoph M Rüegger, MD
christoph.rueegger@usz.ch+41432539810
Backup ContactClaudia Knöpfli
claudia.knoepfli@usz.ch+41442555340

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026