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Ventilation of the Extremely Premature Infants Optimized by Dead Space Washout

Study acronym: Volem
StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Phase: Phase 2 to Not applicablev4
  2. Notable Phase: Not applicable to Phase 2v3 Show 8 more changesShow less
    • Start date: Nov 1, 2024 to Feb 13, 2025
    • Primary endpoint revised
    • Study sites: 0 to 4
    • Primary completion date: Dec 30, 2026 to Apr 2, 2027
    • Study completion date: Dec 31, 2027 to Apr 3, 2029
    • Interventions: ventilation (Device) to Ventilation with Dead Space Washout via Continuous Tracheal Gas Insufflation (CTGI) (Device)
    • Eligibility criteria expanded, about 58 words
    • Secondary endpoints: 21 to 32
  3. Notable Phase: Phase 2 to Not applicable
    • Start date: May 1, 2024 to Nov 1, 2024
    v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06334523
Lead Sponsor Centre Hospitalier Intercommunal Creteil
Conditions
(from sponsor)
Extremely Low Birthweight Infant, Continuous Tracheal Gas Insufflation, Medical Device, Lung Protection, Ventilator-Induced Lung Injury
Related terms Ventilator-Induced Lung Injury
Enrollment 144 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov