NCT Number: NCT06334523
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 opening soon.
Get NotifiedUp to 7 day
All sexes
Interventional
Not applicable
Centre Hospitalier Intercommunal de Creteil, Créteil, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Continuous Tracheal Gas Insufflation, CTGI
Time frame: From birth to the end of hospital stay, up to maximum 45 weeks of corrected gestational age.
The cumulative duration of all periods of non-invasive ventilation, in days, starting from birth, and up to maximum 45 weeks corrected gestational age. Non-invasive ventilation includes all types of positive pressure support non-invasive ventilation and high flow nasal cannula ventilation (HFNC).
Time frame: From enrollment to the date of the end of the hospital stay, up to maximum 5 months of life
For each arm: mortality rate during initial hospitalization.
Time frame: From enrollment to the date of the end of the hospital stay, up to maximum 5 months of life
Mean Driving pressure (∆P: Ppeak-PEEP) collected each 12 hours for all patients on invasive mechanical ventilation.
Time frame: From enrollment to the date of the end of the hospital stay, up to maximum 5 months of life
Mean expiratory tidal volume (VT) collected each 12 hours for all patients on invasive mechanical ventilation.
Time frame: From enrollment up to maximum 15 days of life
Carbon dioxide partial pressure (PCO2) on patient's blood gas during mechanical ventilation
Time frame: From enrollment to the date of the end of the hospital stay, up to maximum 5 months of life
Transcutaneous measure of Carbon dioxide partial pressure (TcPCO2) collected each 12 hours during mechanical ventilation.
Time frame: From birth up to maximum 7 days of life.
Rates of patients with more than one dose of surfactant replacement therapy.
Time frame: From enrollment to the date of the end of the hospital stay, up to maximum 5 months of life
Rates of patients treated with High Frequency ventilation (HFV) or High frequency oscillatory ventilation (HFOV) during invasive mechanical ventilation.
Time frame: From enrollment to the date of the end of the hospital stay, up to maximum 5 months of life
Rates of patients treated with nitric oxyde (iNO) during invasive mechanical ventilation.
Time frame: From enrollment to the date of the end of the hospital stay, up to maximum 5 months of life
Rates of patients with Oxygenation Index ≥ 10
Time frame: From enrollment to the date of the end of the hospital stay, up to maximum 5 months of life
Rates of patients with treated Pneumothorax (Needle Thoracentesis or Chest Drainage)
Time frame: From enrollment to the date of the end of the hospital stay, up to maximum 5 months of life
Rates of patients treated with systemic corticosteroids for the prevention or management of BPD and number of days of treatment, excluding prophylactic hydrocortisone treatment in the first 10 days of life.
Time frame: From two days before 36 weeks of corrected gestational age until two days after 36 weeks of corrected gestational age..
Rates of patients with Bronchopulmonary Dysplasia (BPD) diagnosed at 36 weeks of corrected gestational age.
Time frame: From birth to the date of the end of the hospital stay, up to maximum 5 months of life
Rates of unplanned extubations per 100 ventilator days, and context.
Time frame: From birth to the date of the end of the hospital stay, up to maximum 5 months of life
Number of days spent on invasive mechanical ventilation
Time frame: From birth to the date of the end of the hospital stay, up to maximum 5 months of life
Age at total weaning from invasive mechanical ventilation
Time frame: From birth to the date of the end of the hospital stay, up to maximum 5 months of life
The age in days when the infant is definitively weaned from invasive and non-invasive positive pressure ventilation, excluding High Flow Nasal Canula (HFNC) and Low Flow Nasal Canula ventilation (LFNC).
Time frame: From birth to the date of the end of the hospital stay, up to maximum 5 months of life
The age in days when the infant is definitively weaned from invasive and non-invasive ventilation, including High-Flow Nasal Cannula (HFNC). This excludes Low-Flow Nasal Cannula (LFNC), with or without supplemental oxygen delivery.
Time frame: From birth to the date of the end of the hospital stay, up to maximum 5 months of life
The age in days when the patient is definitively weaned from oxygen supplementation. This includes being weaned from any respiratory support system, as well as from Low-Flow Nasal Cannula, with or without supplemental oxygen delivery.
Time frame: From birth to the date of the end of the hospital stay, up to maximum 5 months of life
Rates of Late-onset primary bloodstream infections using CDC surveillance definitions, calculated for 1000 central-line days.
Time frame: From birth to the date of the end of the hospital stay, up to maximum 5 months of life
Rates of acquired neuroimaging complications: Periventicular Leucomalacia, Cerebellar haemorrhage, Intra-Ventricular Haemorrhage Grade 3 and 4.
Time frame: From birth to the date of the end of the hospital stay, up to maximum 5 months of life
Rates of Retinopathy (ROP) receiving either retinal laser or intravitreal anti-VEGF therapy.
Time frame: From birth to the date of the end of the hospital stay, up to maximum 5 months of life
Number of days with systemic analgesic or sedative treatments.
Time frame: Between 24 hours to 48 hours of life.
Mean Cytokines dosage from tracheal aspirates in intubated patients (one unique aspiration). This outcome will be assessed only for patients enrolled in the study and on mechanical ventilation between 24 and 48 hours of life.
Time frame: Between day 4 to day 5 of life.
Mean Cytokines dosage from tracheal aspirates in intubated patients (one unique aspiration). This outcomes will be assessed only for patients enrolled in the study and on mechanical ventilation between day 4 and 5 of life.
Time frame: Between day 10 to day 12 of life.
Mean Cytokines dosage from tracheal aspirates in intubated patients. This outcomes will be assessed only for patients enrolled in the study and on mechanical ventilation between day 10 and day 12 of life.
Time frame: From enrollment in the study to the date of the end of the hospital stay, up to maximum 5 months of life
Rates of patients receiving hemodynamic support during their hospital stay (systemic catecholamines, volume expansion).
Time frame: From birth to the date of 36 weeks of corrected gestational age.
Weight gain in grams between birth weight and weight at 36 weeks of corrected gestational age.
Time frame: From birth to the date of the end of the hospital stay, up to maximum 5 months of life
Addition of all the periods the patients has a central line, in days.
Time frame: At 2 years of corrected age (± 2 months)
Results of the validated French version of the "Ages & stages questionnaires" (ASQ3), a developmental screening tool based on parental reporting for their child. This tool will be sent to the parents, and collected.
Time frame: At 2 years of corrected age (± 2 months)
Rates of patients with cerebral palsy.
Time frame: At 2 years of corrected age (± 2 months)
Rates of patients with severe visual disorders defined as a need for glasses at 2 years of corrected age (± 2 months)
Time frame: From the date of discharge from the hospital to 2 years of age
Rates of patients with respiratory symptoms in the first two years, defined as the need for respiratory medications (inhaled or systemic) at any time in this period.
Contact information is provided by the study sponsor or research team.
Camille Jung, MD, PhD
CONTACT
Claude Danan, M.D.
CONTACT
Centre Hospitalier Intercommunal Creteil
Other
Open Randomised Study of Conventional Ventilation Optimised by Dead Space Washout in Extremely Premature Infants
Acronym: Volem
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.
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