Clinical trial NCT03250793: Work of Breathing Description in Neonates With Congenital Diaphragmatic Hernia in NAVA and in Conventional Ventilation.
Official title: Physiologic Pilot Study: Work of Breathing Description in Neonates With Congenital Diaphragmatic Hernia in Post-surgical Period Alternatively in Conventional Ventilation (Pressure Controlled) and in NAVA (Neurally Adjusted Ventilatory Assist) Ventilation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hernia, DIaphragmatic, Congenital
Keywords: Hernia, DIaphragmatic, Congenital
Respiration, Artificial
physiologic pilot study
NAVA
Neurally Adjusted Ventilatory Assist
esophageal transducer
Work of Breathing
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-08-16
Enrollment: 8
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Neonate admitted to neonatal intensive care beyond 34 weeks of amenorrhea
* With a diagnosis of congenital diaphragmatic hernia having undergone a repair surgery.
* Necessary invasive ventilatory support by conventional ventilation
* Informed and signed consent of parents (and / or holders of parental authority)

Exclusion Criteria:

* Refusal of parents (and / or holders of parental authority) to participate in the study
* Contra-indication to the use of an oro or naso-gastric tube (oesophageal surgery)
* Child at risk of poor tolerance to the placement of the oesophageal pressure transducer (history of discomfort when placing a tube, weight \<1500g)
* Central or neuromuscular neurological pathology which may affect respiratory control

Primary outcomes:
measure: Work of breathing averaged over 100 consecutive cycles in NAVA ventilation and conventional ventilation
timeFrame: in post-surgical period during 6 hours
Secondary outcomes:
measure: Patient-ventilator synchronization in NAVA
timeFrame: through study completion, an average of 1 year
measure: Patient-ventilator synchronization in conventional ventilation
timeFrame: through study completion, an average of 1 year
measure: Dynamic hyperinflation (intrinsic PEEP) in NAVA
timeFrame: through study completion, an average of 1 year
measure: Dynamic hyperinflation (intrinsic PEEP) in conventional ventilation.
timeFrame: through study completion, an average of 1 year
measure: Ventilation parameters: peak inspiratory pressure in NAVA
timeFrame: through study completion, an average of 1 year
measure: Ventilation parameters: mean pressure in NAVA
timeFrame: through study completion, an average of 1 year
measure: Ventilation parameters: tidal volume in NAVA
timeFrame: through study completion, an average of 1 year
measure: Ventilation parameters: Ti / Ttot ratio in NAVA
timeFrame: through study completion, an average of 1 year
measure: Ventilation parameters: FiO2 in NAVA
timeFrame: through study completion, an average of 1 year
measure: Ventilation parameters: peak inspiratory pressure in conventional ventilation
timeFrame: through study completion, an average of 1 year
measure: Ventilation parameters: mean pressure in conventional ventilation
timeFrame: through study completion, an average of 1 year
measure: Ventilation parameters: tidal volume in conventional ventilation
timeFrame: through study completion, an average of 1 year
measure: Ventilation parameters: Ti / Ttot ratio in conventional ventilation
timeFrame: through study completion, an average of 1 year
measure: Ventilation parameters: FiO2 in conventional ventilation
timeFrame: through study completion, an average of 1 year
measure: Physiological parameters indirectly evaluating work of breathing: esophageal swing in NAVA
timeFrame: through study completion, an average of 1 year
measure: Physiological parameters indirectly evaluating work of breathing: diaphragmatic swing in NAVA
timeFrame: through study completion, an average of 1 year
measure: Physiological parameters indirectly evaluating work of breathing: esophageal swing in conventional ventilation
timeFrame: through study completion, an average of 1 year
measure: Physiological parameters indirectly evaluating work of breathing: diaphragmatic swing in conventional ventilation
timeFrame: through study completion, an average of 1 year
measure: Clinical parameters of neonates: respiratory rate in NAVA
timeFrame: through study completion, an average of 1 year
measure: Clinical parameters of neonates: heart rate in NAVA
timeFrame: through study completion, an average of 1 year
measure: Clinical parameters of neonates: blood pressure in NAVA
timeFrame: through study completion, an average of 1 year
measure: Clinical parameters of neonates: respiratory rate in conventional ventilation
timeFrame: through study completion, an average of 1 year
measure: Clinical parameters of neonates: heart rate in conventional ventilation
timeFrame: through study completion, an average of 1 year
measure: Clinical parameters of neonates: blood pressure in conventional ventilation
timeFrame: through study completion, an average of 1 year
measure: Gas exchange: measurement of transcutaneous SaO2 in NAVA
timeFrame: through study completion, an average of 1 year
measure: Gas exchange: measurement of transcutaneous pCO2 in NAVA
timeFrame: through study completion, an average of 1 year
measure: Gas exchange: measurement of transcutaneous pCO2 in conventional ventilation
timeFrame: through study completion, an average of 1 year
measure: Gas exchange: measurement of transcutaneous SaO2 in conventional ventilation
timeFrame: through study completion, an average of 1 year
measure: Neonate comfort scores: COMFORT-BEHAVIOR score in NAVA
timeFrame: through study completion, an average of 1 year
measure: Neonate comfort scores: COMFORT-BEHAVIOR score in conventional ventilation
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Bron
country: France
facility: Service de Réanimation Néonatale- Hôpital Femme Mère Enfant- Hospices Civils de Lyon
Study officials:
affiliation: Service de Réanimation Néonatale- Hôpital Femme Mère Enfant- Hospices Civils de Lyon
name: Lélia Dreyfus, MD
role: PRINCIPAL_INVESTIGATOR
References: