Pulmonary Volume Changes During Synchonized Noninvasive Positive Pressure Ventilation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Electrical Impedance Tomography (EIT).
- Who it may be relevant to
- Registry conditions: Infant, Preterm, Respiratory Distress Syndrome (Neonatal), Chronic Lung Disease of Newborn, Respiratory Support. Basic parameters: up to 4 Weeks · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Intrapulmonary Volume Changes During Synchronized Noninvasive Positive Pressure Ventilation In Preterm Infants
Overview
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
- Device Electrical 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.
Primary outcome measures
- Tidal volume (VT) [Time frame: At five pre-defined timepoints from the beginning to the end of the study at 180 minutes.]
Secondary outcome measures (12)
- Global lung impedance [Time frame: At five pre-defined timepoints from the beginning to the end of the study at 180 minutes.]
- Regional tidal volume distribution [Time frame: At five pre-defined timepoints from the beginning to the end of the study at 180 minutes.]
- Center of ventilation [Time frame: At five pre-defined timepoints from the beginning to the end of the study at 180 minutes.]
- Silent spaces [Time frame: At five pre-defined timepoints from the beginning to the end of the study at 180 minutes.]
- Global inhomogeneity index [Time frame: At five pre-defined timepoints from the beginning to the end of the study at 180 minutes.]
- Coefficient of variation [Time frame: At five pre-defined timepoints from the beginning to the end of the study at 180 minutes.]
- Inspiratory time [Time frame: At five pre-defined timepoints from the beginning to the end of the study at 180 minutes.]
- Expiratory time [Time frame: At five pre-defined timepoints from the beginning to the end of the study at 180 minutes.]
- Lung ultrasound score [Time frame: Immediately before the first infant handling as well as following electrical impedance tomography belt removal.]
- Heart rate [Time frame: Continuous measurement during the 180-minute recording period.]
- Peripheral oxygen saturation [Time frame: Continuous measurement during the 180-minute recording period.]
- Oxygen supplementation [Time frame: Continuous measurement during the 180-minute recording period.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Switzerland · 1 center
- University Hospital Zurich — Zurich
Identifiers
NCT: NCT07237139 · INSPIRE