An interventional study of Physiologic study measuring work of breathing which can be estimated by the esophageal and trans-diaphragmatic pressure-time product obtained by an esophageal transducer in Hernia, DIaphragmatic, Congenital, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to participants aged 1 Year and older. Per ClinicalTrials.gov, last updated 2025-09-04.
Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Other
Congenital diaphragmatic hernia (CDH) is a congenital malformation associated with significant mortality and respiratory morbidity, particularly related to prolonged mechanical ventilation. NAVA (Neurally Adjusted Ventilatory Assist) is a recent technique that uses the recognition of the electrical activity of the patient's diaphragm (Edi) and delivers a synchronized proportional assisted ventilation. This technique has already been used in the newborn, especially premature and has shown many benefits. Only one study in the literature shows its feasibility in newborns with CDH. This technique seems interesting in the context of CDH because it would limit baro-trauma and improve synchronization. Before demonstrating the clinical benefits, it seems important to describe the effects on the respiratory physiology, in particular on work of breathing which can be estimated by the esophageal and trans-diaphragmatic pressure-time product obtained by an esophageal transducer. Our study is an innovative physiologic pilot study with the objective to describe work of breathing in neonates with CDH in post-surgical period in NAVA ventilation and in conventional ventilation using an esophageal transducer. It will provide the clinician with a physiological justification for the use of NAVA to rapidly improve the respiratory muscular dynamics of these patients. This study is a prerequisite for the realization of studies demonstrating the clinical benefit of NAVA ventilation on reduction of duration of ventilation and more generally on morbidity and mortality in the population of neonate with CDH.
23 studies on the registry are indexed under Hernia, Diaphragmatic; 4 are open to participants now.
This study's enrollment of 8 is below the median of 33 across 17 interventional studies indexed under Hernia, Diaphragmatic.
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Neonates with congenital diaphragmatic hernia in post-surgical period under mechanical ventilation during weaning of mechanical ventilation
Device: Physiologic study measuring work of breathing which can be estimated by the esophageal and trans-diaphragmatic pressure-time product obtained by an esophageal transducer
While the patient is under respiratory assistance on the SERVO-I respirator, he will be included in the study and one esophageal transducer of 2,3 mm of diameter will be inserted through the mouth / nose in addition to NAVA's naso / Oro-Gastric tube( Edi Catheter, 6Fr, 49 cm, PHT free 5 pcs / pkg or Catheter Edi, 6Fr, 50 cm, PHT free 5 pcs / pkg). Measurements will be performed using the esophageal transducer under two conditions: 2 hours in conventional ventilation (pressure controlled), 2 hours in NAVA ventilation and then again 2 hours in conventional ventilation (PC) for a total duration of 6 hours.The parameters of conventional ventilation will be left free at the choice of the neonatologist and will be identical between the two periods of conventional ventilation. The initial NAVA level will be defined by the neonatologist using pre-visualization curves. All signals will be recorded via an amplification and acquisition system. Values will be averaged over 100 cycles.
Work of breathing averaged over 100 consecutive cycles in NAVA ventilation and conventional ventilation
Work of breathing is estimated by the esophageal and trans-diaphragmatic pressure-time product obtained by an esophageal transducer
Time frame: in post-surgical period during 6 hours
Patient-ventilator synchronization in NAVA
Comparison of the asynchrony indexes between the 2 modes (Number of asynchronies / Number of respiratory cycles)
Time frame: through study completion, an average of 1 year
Patient-ventilator synchronization in conventional ventilation
Comparison of the asynchrony indexes between the 2 modes (Number of asynchronies / Number of respiratory cycles)
Time frame: through study completion, an average of 1 year
Dynamic hyperinflation (intrinsic PEEP) in NAVA
Intrinsic PEEP average over 100 cycles
Time frame: through study completion, an average of 1 year
Dynamic hyperinflation (intrinsic PEEP) in conventional ventilation.
Intrinsic PEEP average over 100 cycles
Time frame: through study completion, an average of 1 year
Ventilation parameters: peak inspiratory pressure in NAVA
Evolution of the following parameters: peak inspiratory pressure, mean pressure, tidal volume, Ti / Ttot ration, FiO2
Time frame: through study completion, an average of 1 year
Ventilation parameters: mean pressure in NAVA
Evolution of the following parameters: peak inspiratory pressure, mean pressure, tidal volume, Ti / Ttot ration, FiO2
Time frame: through study completion, an average of 1 year
Ventilation parameters: tidal volume in NAVA
Evolution of the following parameters: peak inspiratory pressure, mean pressure, tidal volume, Ti / Ttot ration, FiO2
Time frame: through study completion, an average of 1 year
Ventilation parameters: Ti / Ttot ratio in NAVA
Evolution of the following parameters: peak inspiratory pressure, mean pressure, tidal volume, Ti / Ttot ration, FiO2
Time frame: through study completion, an average of 1 year
Ventilation parameters: FiO2 in NAVA
Evolution of the following parameters: peak inspiratory pressure, mean pressure, tidal volume, Ti / Ttot ration, FiO2
Time frame: through study completion, an average of 1 year
Ventilation parameters: peak inspiratory pressure in conventional ventilation
Evolution of the following parameters: peak inspiratory pressure, mean pressure, tidal volume, Ti / Ttot ration, FiO2
Time frame: through study completion, an average of 1 year
Ventilation parameters: mean pressure in conventional ventilation
Evolution of the following parameters: peak inspiratory pressure, mean pressure, tidal volume, Ti / Ttot ration, FiO2
Time frame: through study completion, an average of 1 year
Ventilation parameters: tidal volume in conventional ventilation
Evolution of the following parameters: peak inspiratory pressure, mean pressure, tidal volume, Ti / Ttot ration, FiO2
Time frame: through study completion, an average of 1 year
Ventilation parameters: Ti / Ttot ratio in conventional ventilation
Evolution of the following parameters: peak inspiratory pressure, mean pressure, tidal volume, Ti / Ttot ration, FiO2
Time frame: through study completion, an average of 1 year
Ventilation parameters: FiO2 in conventional ventilation
Evolution of the following parameters: peak inspiratory pressure, mean pressure, tidal volume, Ti / Ttot ration, FiO2
Time frame: through study completion, an average of 1 year
Physiological parameters indirectly evaluating work of breathing: esophageal swing in NAVA
Averages of the esophageal and diaphragmatic swings over 100 cycles in each period. Esophageal and diaphragmatic swings are physiological parameters obtained by the esophageal transducer which expressed muscle strength.
Time frame: through study completion, an average of 1 year
Physiological parameters indirectly evaluating work of breathing: diaphragmatic swing in NAVA
Averages of the esophageal and diaphragmatic swings over 100 cycles in each period. Esophageal and diaphragmatic swings are physiological parameters obtained by the esophageal transducer which expressed muscle strength.
Time frame: through study completion, an average of 1 year
Physiological parameters indirectly evaluating work of breathing: esophageal swing in conventional ventilation
Averages of the esophageal and diaphragmatic swings over 100 cycles in each period. Esophageal and diaphragmatic swings are physiological parameters obtained by the esophageal transducer which expressed muscle strength.
Time frame: through study completion, an average of 1 year
Physiological parameters indirectly evaluating work of breathing: diaphragmatic swing in conventional ventilation
Averages of the esophageal and diaphragmatic swings over 100 cycles in each period. Esophageal and diaphragmatic swings are physiological parameters obtained by the esophageal transducer which expressed muscle strength.
Time frame: through study completion, an average of 1 year
Clinical parameters of neonates: respiratory rate in NAVA
Evolution of clinical parameters (respiratory rate, heart rate, blood pressure) at the beginning and end of each period
Time frame: through study completion, an average of 1 year
Clinical parameters of neonates: heart rate in NAVA
Evolution of clinical parameters (respiratory rate, heart rate, blood pressure) at the beginning and end of each period
Time frame: through study completion, an average of 1 year
Clinical parameters of neonates: blood pressure in NAVA
Evolution of clinical parameters (respiratory rate, heart rate, blood pressure) at the beginning and end of each period
Time frame: through study completion, an average of 1 year
Clinical parameters of neonates: respiratory rate in conventional ventilation
Evolution of clinical parameters (respiratory rate, heart rate, blood pressure) at the beginning and end of each period
Time frame: through study completion, an average of 1 year
Clinical parameters of neonates: heart rate in conventional ventilation
Evolution of clinical parameters (respiratory rate, heart rate, blood pressure) at the beginning and end of each period
Time frame: through study completion, an average of 1 year
Clinical parameters of neonates: blood pressure in conventional ventilation
Evolution of clinical parameters (respiratory rate, heart rate, blood pressure) at the beginning and end of each period
Time frame: through study completion, an average of 1 year
Gas exchange: measurement of transcutaneous SaO2 in NAVA
Evolution of oxygenation parameters (SpO2) and transcutaneous CO2 (pCO2) during each period. SpO2 and pCO2 are measured continuously; average and median will be valued in each period of the study. No blood test will be required.
Time frame: through study completion, an average of 1 year
Gas exchange: measurement of transcutaneous pCO2 in NAVA
Evolution of oxygenation parameters (SpO2) and transcutaneous CO2 (pCO2) during each period. SpO2 and pCO2 are measured continuously; average and median will be valued in each period of the study. No blood test will be required.
Time frame: through study completion, an average of 1 year
Gas exchange: measurement of transcutaneous pCO2 in conventional ventilation
Evolution of oxygenation parameters (SpO2) and transcutaneous CO2 (pCO2) during each period. SpO2 and pCO2 are measured continuously; average and median will be valued in each period of the study. No blood test will be required.
Time frame: through study completion, an average of 1 year
Gas exchange: measurement of transcutaneous SaO2 in conventional ventilation
Evolution of oxygenation parameters (SpO2) and transcutaneous CO2 (pCO2) during each period. SpO2 and pCO2 are measured continuously; average and median will be valued in each period of the study. No blood test will be required.
Time frame: through study completion, an average of 1 year
Neonate comfort scores: COMFORT-BEHAVIOR score in NAVA
Evaluation of comfort (COMFORT-BEHAVIOR scale) at the beginning and at the end of each period.
Time frame: through study completion, an average of 1 year
Neonate comfort scores: COMFORT-BEHAVIOR score in conventional ventilation
Evaluation of comfort (COMFORT-BEHAVIOR scale) at the beginning and at the end of each period.
Time frame: through study completion, an average of 1 year
Ran from Aug 2018 to primary completion in Jan 2021, 29 months.
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