Ventilation of the Extremely Premature Infants Optimized by Dead Space Washout

NCT ID: NCT06334523

Last Updated: 2025-02-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-13
• Study Completion Date: 2029-04-03

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Continuous Tracheal Gas Insufflation

the preterm infant intubated and ventilated with Continuous Tracheal Gas Insufflation

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Standard ventilation without CTGI

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Continuous Tracheal Gas Insufflation; CTGI

Eligibility Criteria

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

• Maximum Eligible Age: 7 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Intercommunal Creteil

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Juliana PATKAI, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Cochin-Port Royal

Valérie BIRAN, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU Robert Debré

Cyril FLAMANT, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Fabrice DECOBERT, MD

Role: PRINCIPAL_INVESTIGATOR

CHI de Créteil

Locations

Centre Hospitalier Intercommunal de Creteil

Créteil, , France

Centre Hospitalier Universitaire de Nantes

Nantes, , France

Centre Hopistalier Universitaire Cochin Port Royal aphp

Paris, , France

Centre hospitalier Robert Debré aphp

Paris, , France

Countries

France

Central Contacts

Claude Danan, M.D.

Role: CONTACT

claude.danan@chicreteil.fr

+33609187562

Camille Jung, MD, PhD

Role: CONTACT

camille.jung@chicreteil.fr

+33157022268

Facility Contacts

Fabrice Decobert, MD

Role: primary

fabrice.decobert@chicreteil.fr

+33

laurence caeymaex, MD PhD

Role: backup

laurence.caeymaex@gmail.com

+33664095607

Fabrice Decobert, MD

Role: backup

Cyril Flamant, MD PhD

Role: primary

cyril.flamant@chu-nantes.fr

+33240083483

Geraldine Apprioual, MD

Role: backup

geraldine.apprioual@chu-nantes.fr

+33240083483

cyril flamant, MD PhD

Role: backup

Juliana Patkai, MD

Role: primary

juliana.patkai@aphp.fr

+33158413645

Juliana Patkai, MD

Role: backup

Valerie Biran, MD PhD

Role: primary

valerie.biran@aphp.fr

+33140034191

Nizar Khattat, MD

Role: backup

nizar.khattat@aphp.fr

+33140031331

valerie biran, MD PhD

Role: backup

Other Identifiers

Volem

Identifier Type: -

Identifier Source: org_study_id