NCT06334523

Ventilation of the Extremely Premature Infants Optimized by Dead Space Washout

Open Randomised Study of Conventional Ventilation Optimised by Dead Space Washout in Extremely Premature Infants

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: Centre Hospitalier Intercommunal Creteil · Academic / Other
• Sex: All
• Age: 7 Days
• Healthy volunteers: Not accepted

Summary

The Continuous Tracheal Gas Insufflation (CTGI) is a ventilation option of conventional mechanical ventilation that is used to reduce or even eliminate the dead space caused by respiratory prostheses. This objective is of particular interest in the smallest preterm infants, where the volume of anatomical dead space due to prostheses is little different from the tidal volume. The principle of this option is to continuously blow an additional flow of 0.2 L/minute at the tip of the endotracheal tube to purge expired CO2 trapped in the prostheses, to have a CO2-free volume of gas available for subsequent insufflation. The goal of this clinical trial is to learn if Continuous Tracheal Gas Insufflation (CTGI) works to reduce ventilatory dependence in preterm infants after mechanical ventilation. It will also learn about the safety of CTGI. The main questions it aims to answer are: * Does Continuous Tracheal Gas Insufflation (CTGI) reduce the number of days of non-invasive ventilation in extremely preterm infants who needed mechanical ventilation? * Does Continuous Tracheal Gas Insufflation (CTGI) reduce the age at the weaning of any ventilatory support and/or oxygen supplementation. Researchers will compare the clinical outcome of patients mechanically ventilated with the CTGI-device to the outcome of patients ventilated without the CTGI device, to see if the CTGI ventilation works to reduce ventilation dependence. Participants will: • Be mechanically ventilated using CTGI (if randomly assigned in the CTGI-group), for the entire endotracheal ventilation period during their stay in the neonatal intensive care unit.

Conditions

• Extremely Low Birthweight Infant
• Continuous Tracheal Gas Insufflation
• Medical Device
• Lung Protection
• Ventilator-Induced Lung Injury

Interventions

Type	Name	Description
DEVICE	Ventilation with Dead Space Washout via Continuous Tracheal Gas Insufflation (CTGI)	The intervention involves adding a device which allows CTGI (the "CTGI-device") to washout the dead space in preterm mechanically ventilated infants. Dead space washout using the CTGI-device is an option added to standard ventilation, to reduce or even cancel anatomical dead space due to respiratory prostheses in intubated preterm infants.

Timeline

• Start date: 2025-02-13
• Primary completion: 2027-04-02
• Completion: 2029-04-03
• First posted: 2024-03-28
• Last updated: 2025-02-05

Locations

4 sites across 1 country: France

Regulatory

• FDA-regulated device study