Ventilation of the Extremely Premature Infants Optimized by Dead Space Washout

NCT06334523 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: Volem
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

lung protection; extremely low birthweight infant; Ventilator-Induced Lung Injury; mechanical ventilation

Outcome Measures

Primary Outcomes (1)

• Cumulative duration of all periods of non-invasive ventilation

  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).

  From birth to the end of hospital stay, up to maximum 45 weeks of corrected gestational age.

Secondary Outcomes (32)

• Number of participants deceased

  From enrollment to the date of the end of the hospital stay, up to maximum 5 months of life

• Measure of the Driving Pressure during mechanical ventilation

  From enrollment to the date of the end of the hospital stay, up to maximum 5 months of life

• Measure of expiratory tidal volume during mechanical ventilation.

  From enrollment to the date of the end of the hospital stay, up to maximum 5 months of life

• Measure of carbon dioxide partial pressure (PCO2) on blood gas

  From enrollment up to maximum 15 days of life

• Measure of Transcutaneous Carbon dioxide partial pressure (TcPCO2)

  From enrollment to the date of the end of the hospital stay, up to maximum 5 months of life

Study Arms (2)

Continuous Tracheal Gas Insufflation

EXPERIMENTAL

the preterm infant intubated and ventilated with Continuous Tracheal Gas Insufflation

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

Standard ventilation without CTGI

NO INTERVENTION

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

Interventions

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

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.

Also known as: Continuous Tracheal Gas Insufflation, CTGI

Continuous Tracheal Gas Insufflation

Eligibility Criteria

• Age: Up to 7 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Intercommunal Creteil: lead

Study Sites (4)

Centre Hospitalier Intercommunal de Creteil

Créteil, 94010, France

Location

Centre Hospitalier Universitaire de Nantes

Nantes, 44000, France

Location

Centre Hopistalier Universitaire Cochin Port Royal aphp

Paris, 75014, France

Location

Centre hospitalier Robert Debré aphp

Paris, 75019, France

Location

MeSH Terms

Conditions

Ventilator-Induced Lung Injury

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Juliana PATKAI, MD

  CHU Cochin-Port Royal

  PRINCIPAL INVESTIGATOR

• Valérie BIRAN, MD, PhD

  CHU Robert Debré

  PRINCIPAL INVESTIGATOR

• Cyril FLAMANT, MD, PhD

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

• Fabrice DECOBERT, MD

  CHI de Créteil

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Claude Danan, M.D.

CONTACT

+33609187562; claude.danan@chicreteil.fr

Camille Jung, MD, PhD

CONTACT

+33157022268; camille.jung@chicreteil.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: March 28, 2024
• Study Start: February 13, 2025
• Primary Completion (Estimated): April 2, 2027
• Study Completion (Estimated): April 3, 2029
• Last Updated: February 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)