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Clinical Trials/NCT07465237
NCT07465237CompletedNot Applicable

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

Hacettepe University1 site in 1 country17 target enrollmentStarted: July 15, 2023Last updated:
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
17
Locations
1
Primary Endpoint
Change in peak inspiratory pressure

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
0 Days to 28 Days (Child)
Sex
All
Accepts 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

Arms & Interventions

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.

Intervention: Pressure Rise Time Adjustment (Device)

Outcomes

Primary Outcomes

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

  • Change in mean airway pressure(Immediately after ventilator adjustment)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ferid Aliyev

MD

Hacettepe University

Study Sites (1)

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