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| ID | Type | Description | Link |
|---|---|---|---|
| KA-21062 | Other Identifier | Hacettepe University Clinical Research Ethics Committee |
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This study investigates the short-term physiological effects of pressure rise time modulation during volume-guaranteed ventilation in neonates. Pressure rise time is an adjustable parameter that influences how quickly inspiratory pressure reaches the target level during mechanical ventilation.
In this study, different pressure rise time settings will be applied during volume-guaranteed ventilation, and their effects on respiratory parameters, gas exchange, and patient-ventilator interaction will be evaluated. The aim is to determine whether modulation of pressure rise time has measurable short-term physiological effects in ventilated neonates and to identify optimal ventilator settings that may improve respiratory support.
Mechanical ventilation is frequently required in neonatal intensive care units, particularly for preterm infants with respiratory distress. Volume-guaranteed ventilation is commonly used because it helps maintain stable tidal volumes while minimizing ventilator-induced lung injury.
Pressure rise time is a ventilator parameter that determines how quickly inspiratory pressure reaches the target level at the beginning of each breath. Alterations in pressure rise time may influence inspiratory flow characteristics, patient-ventilator synchrony, and overall respiratory mechanics. However, limited data are available regarding the short-term physiological effects of pressure rise time modulation during volume-guaranteed ventilation in neonates.
The objective of this study is to evaluate the short-term physiological responses to different pressure rise time settings during volume-guaranteed ventilation in neonates receiving respiratory support in the neonatal intensive care unit. Respiratory parameters, ventilator measurements, and gas exchange indicators will be monitored while sequentially applying different pressure rise time settings.
The findings of this study may contribute to a better understanding of ventilator parameter optimization in neonatal respiratory care and may help guide clinicians in selecting ventilator settings that improve patient-ventilator interaction and respiratory stability.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pressure Rise Time Modulation | Experimental | Neonates receiving volume-guaranteed ventilation in whom different pressure rise time settings are sequentially applied to evaluate short-term physiological effects. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pressure Rise Time Adjustment | Device | Adjustment of pressure rise time settings during volume-guaranteed neonatal ventilation to evaluate short-term physiological responses. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in peak inspiratory pressure | Assessment of changes in peak inspiratory pressure following different pressure rise time settings. | Immediately after pressure rise time adjustment during the study procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Change in mean airway pressure | Evaluation of changes in mean airway pressure associated with different pressure rise time settings during volume-guaranteed ventilation. | Immediately after ventilator adjustment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ferid Aliyev, MD | Hacettepe University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hacettepe University Faculty of Medicine | Ankara | 06100 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Aliyev F. Pressure rise time modulation during neonatal ventilation: study protocol. Hacettepe University Faculty of Medicine. 2026. | ||
| 41912661 | Derived | Aliyev F, Yigit S, Yucel E, Tandircioglu UA. Short-term physiological effects of pressure rise time modulation during volume-guaranteed neonatal ventilation. Sci Rep. 2026 Mar 30;16(1):10620. doi: 10.1038/s41598-026-44486-5. |
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Individual participant data will not be shared due to institutional data protection policies and patient confidentiality considerations.
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Different pressure rise time settings will be sequentially applied during volume-guaranteed ventilation in the same neonates, and short-term physiological responses will be evaluated.
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