Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06334523
Other study ID # Volem
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date November 1, 2024
Est. completion date December 31, 2027

Study information

Verified date May 2024
Source Centre Hospitalier Intercommunal Creteil
Contact Claude Danan
Phone 0157022268
Email claude.Danan@chicreteil.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The Continuous Tracheal Gas Insufflation (CTGI) is a ventilation option of conventional ventilation to reduce or even cancel dead space due to respiratory prostheses. This objective is particularly interesting in the smallest preterm infants in which 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/min at tip of endotracheal tube to purge expired CO2 trapped in the prostheses to have a CO2-free volume of gas available for subsequent insufflation.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 144
Est. completion date December 31, 2027
Est. primary completion date December 30, 2026
Accepts healthy volunteers No
Gender All
Age group 23 Weeks to 26 Weeks
Eligibility Inclusion Criteria: - Term between 23sa + 0j to 26sa + 6j - Age 7 days - Research associated DMs available - beneficiary of a social security scheme Exclusion Criteria: - Carrier of a malformation that can alter the prognosis - Carrier of a grade >2 intraventricular hemorrhage or other abnormality - brain that can alter prognosis. - Carrier of a genetic abnormality that can alter the prognosis.

Study Design


Intervention

Device:
ventilation
the premature infant will be ventillad by respirator and medical device "S-lem" for reduce the Continuous Tracheal Gas Insufflation (CTGI). The CTGI is a ventilation option conventional to reduce or even cancel space anatomical death due to respiratory prostheseses.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Intercommunal Creteil

Outcome

Type Measure Description Time frame Safety issue
Primary cumulative duration of non-invasive ventilation periods in living patients It is measured in number of days until the end of 45 gestation week or until the definitive withdrawal of any ventilatory support in positive pressure if it intervenes before 45 gestation week 45 weeks of corrected gestational age.
Secondary The pressure gradient of the ventilation Pressure gradient level in invasive ventilation up to 24 weeks
Secondary The age at the definitive withdrawal of any ventilatory support (PPS) Age at definitive withdrawal from invasive ventilation "up to 36 weeks of corrected gestational age
Secondary Definitive weaning age of invasive ventilation age at total weaning from any ventilatory support "up to 36 weeks of corrected gestational age
Secondary Definitive O2 weaning age age at total weaning from oxygen at the end of the intervention/procedure/surgery"
Secondary the death rate the death rate "through study completion
Secondary The rate of recourse to the HFO Frequency of HFO (High Frequency Oscillation) "up to 36 weeks of corrected gestational age
Secondary The level of pneumothorax Pneumothorax frequency through study completion
Secondary The rate of bronchopulmonary dysplasia (BPD) diagnosed The rate of bronchopulmonary dysplasia (BPD) diagnosed 36 week of gestational age via the Walsh test
Secondary Rate of postnatal systemic corticosteroid therapy Rate of postnatal systemic corticosteroid therap through study completion
Secondary Duration of exposure to systemic sedatives cumulative day with systemic sedative prescription through study completion
Secondary The cumulative day invasive ventilation The cumulative day invasive ventilation "up to 36 weeks of corrected gestational age
Secondary Non-programmed extubation rate Frequency of unscheduled extubations "up to 36 weeks of corrected gestational age
Secondary Rate of secondary blooddstream infection Rate of secondary blooddstream infection through study completion
Secondary neuroimaging complication description of neuroimaging complication through study completion
Secondary Neurodevelopmental monitoring Ages and stages questionnaires, ASQ test at 2 years of age
Secondary Pulmonary inflammation by cytokine dosage for intubated patients cytokines dosage between 24 hours to 48 hours of inclusion
Secondary Pulmonary inflammation by cytokine dosage for intubated patients cytokines dosage between day 4 to day 5 of inclusion
Secondary Pulmonary inflammation by cytokine dosage for intubated patients cytokines dosage between day 10 to day 12 of inclusion
Secondary rate of Retinopathy rank >1 rate of Retinopathy rank >1 through study completion
Secondary severe hypoxemia number of patient with oxygenation index = 10 "up to 36 weeks of corrected gestational age
Secondary Additional dose of surfactant number of patient with an additional dose of surfactant "up to 36 weeks of corrected gestational age
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06296173 - Open Lung Protective Extubation Following General Anesthesia N/A
Not yet recruiting NCT03245684 - Assisted or Controlled Ventilation in Ards (Ascovent) N/A
Completed NCT03401463 - Assesment of the Endotracheal Tube Cuff Pressure Values in ICU Pateints Before and After Training Seminar N/A
Completed NCT02386683 - Intraoperative Lung-Protective Ventilation in Neurosurgery N/A
Completed NCT03651817 - Lung Protection Strategy in Open Heart Surgery: Which Tidal Volume is Better 8ml/kg or 6ml/kg N/A
Recruiting NCT03709199 - Long Term Follow up of Children Enrolled in the REDvent Study
Recruiting NCT03367221 - Physiological Response in Lung Transplant Recipients Undergoing Neurally Adjusted Ventilatory Assist N/A
Completed NCT03056885 - Inflammatory Local Response During OLV: Protective vs Conventional Ventilation Strategy N/A
Recruiting NCT03746236 - Transpulmonary Pressure Under Stressing Conditions
Recruiting NCT03719365 - Driving Pressure Variation: NAVA vs PSV N/A
Completed NCT03659552 - Percutaneous Temporary Placement of a Transvenous Phrenic Nerve Stimulator for Diaphragm Pacing Using Jugular Access N/A
Completed NCT02732041 - Asynchrony During Mechanical Ventilation in Patients With Acute Respiratory Distress Syndrome
Terminated NCT03525691 - Enhanced Lung Protective Ventilation With ECCO2R During ARDS N/A
Not yet recruiting NCT05859906 - The Effect of Two Different Intra-abdominal Pressure Applications on "Mechanical Power" in Laparoscopic Cholecystectomy
Recruiting NCT05977153 - CT for Personalized Mechanical Ventilation N/A
Active, not recruiting NCT06430606 - Novel Oxygenation Indices in Robot-Assisted Laparoscopic Surgeries
Recruiting NCT04484727 - "Lung Barometric Measurements in Normal And in Respiratory Distressed Lungs"
Recruiting NCT05991258 - Effect of End-inspiratory Airway Pressure Measurements on the Risk of VILI in Ventilated Patients
Terminated NCT03951064 - Providing Optimal PEEP During Mechanical Ventilation for Obese Patients Using Esophageal Balloon N/A
Recruiting NCT03945409 - New Automated System for Continuous Real-time Monitoring of Transpulmonary Pressure