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Pressure Rise Time Modulation During Volume-Guaranteed Neonatal Ventilation

Short-term Physiological Effects of Pressure Rise Time Modulation During Volume-Guaranteed Neonatal Ventilation

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07465237
Enrollment
17
Registered
2026-03-11
Start date
2023-07-15
Completion date
2024-07-15
Last updated
2026-03-11

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

Conditions

Mechanical Ventilation, Respiratory Distress in Neonates

Keywords

Neonatal ventilation, Volume-guaranteed ventilation, Pressure rise time, Mechanical ventilation, Neonate, Ventilator settings

Brief summary

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.

Detailed description

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.

Interventions

DEVICEPressure Rise Time Adjustment

Adjustment of pressure rise time settings during volume-guaranteed neonatal ventilation to evaluate short-term physiological responses.

Sponsors

Hacettepe University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
0 Days to 28 Days
Healthy volunteers
No

Inclusion criteria

* Inclusion Criteria: * Neonates receiving volume-guaranteed mechanical ventilation * Patients monitored in the neonatal intensive care unit * Clinically stable neonates undergoing ventilator setting adjustments

Exclusion criteria

* Major congenital anomalies affecting respiratory function * Hemodynamic instability * Patients requiring immediate ventilator mode changes or emergency interventions

Design outcomes

Primary

MeasureTime frameDescription
Change in peak inspiratory pressureImmediately after pressure rise time adjustment during the study procedureAssessment of changes in peak inspiratory pressure following different pressure rise time settings.

Secondary

MeasureTime frameDescription
Change in mean airway pressureImmediately after ventilator adjustmentEvaluation of changes in mean airway pressure associated with different pressure rise time settings during volume-guaranteed ventilation.

Countries

Turkey (Türkiye)

Contacts

PRINCIPAL_INVESTIGATORFerid Aliyev, MD

Hacettepe University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026