Skip to main content
OpenTrials
Completed

NCT Number: NCT07465237

Pressure Rise Time Modulation During Volume-Guaranteed Neonatal Ventilation

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

0 day–28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hacettepe University Faculty of Medicine

Ankara, 06100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pressure Rise Time Adjustment

Device

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

Primary outcomes

  1. Change in peak inspiratory pressure

    Time frame: Immediately after pressure rise time adjustment during the study procedure

    Assessment of changes in peak inspiratory pressure following different pressure rise time settings.

Secondary outcomes

  1. Change in mean airway pressure

    Time frame: Immediately after ventilator adjustment

    Evaluation of changes in mean airway pressure associated with different pressure rise time settings during volume-guaranteed ventilation.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 11, 2026
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.