Pressure Rise Time Modulation During Volume-Guaranteed Neonatal Ventilation

NCT07465237 | Completed

• 1 other identifier: KA-21062
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Distress in Neonates; Mechanical Ventilation

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Change in mean airway pressure

  Immediately after ventilator adjustment

Study Arms (1)

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.

Device: Pressure Rise Time Adjustment

Interventions

Pressure Rise Time Adjustment DEVICE

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

Pressure Rise Time Modulation

Eligibility Criteria

• Age: 0 Days - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University Faculty of Medicine

Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (1)

• Aliyev F. Pressure rise time modulation during neonatal ventilation: study protocol. Hacettepe University Faculty of Medicine. 2026.

  BACKGROUND

Study Officials

• Ferid Aliyev, MD

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: 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.

Study Record Dates

• First Submitted: March 8, 2026
• First Posted: March 11, 2026
• Study Start: July 15, 2023
• Primary Completion: July 15, 2024
• Study Completion: July 15, 2024
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)