Ventilation of the Extremely Premature Infants Optimized by Dead Space Washout (Volem)

Centre Hospitalier Intercommunal Creteil

Status: Not yet enrolling

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

Treatments: Device: Ventilation with Dead Space Washout via Continuous Tracheal Gas Insufflation (CTGI)

Study type: Interventional

Funder types: Other

Identifiers

NCT06334523

Volem

Details and patient eligibility

About

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.

Enrollment: 144 estimated patients

Sex: All

Ages: 23 weeks to 7 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Gestational Age at birth between 23 weeks gestation + 0 days and 26 weeks gestation + 6days
• Age between 0 and 7 days of life
• Need for intubation and mechanical ventilation before day 8 of life
• Availability of the Research-associated medical devices
• Beneficiary of a social security system (in France: CMU or securité sociale)
• Parental consent for their infant to participate in this trial

Exclusion criteria

• Known Severe Congenital Malformation (potential life-threatening malformation)
• Known Preexisting Severe Intraventricular Haemorrhage (grade 3 or 4) and/or other brain abnormality that can alter life prognosis
• Known Genetic Disorder (potential life-threatening malformation)
• Preexistent mechanical ventilation for a duration of more than 12 hours
• Participation in another interventional research trial before inclusion

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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144 participants in 2 patient groups

Continuous Tracheal Gas Insufflation

Experimental group

Description:

the preterm infant intubated and ventilated with Continuous Tracheal Gas Insufflation

Treatment:

Device: Ventilation with Dead Space Washout via Continuous Tracheal Gas Insufflation (CTGI)

Standard ventilation without CTGI

No Intervention group

Description:

In the No Intervention arm, the preterm infants are mechanically ventilated using standard ventilation, without the CTGI-device. There is no dead space washout.