Work of Breathing Description in Neonates With Congenital Diaphragmatic Hernia in NAVA and in Conventional Ventilation.

Not Applicable

Completed

• Conditions: Hernia, DIaphragmatic, Congenital
• Interventions: 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

• Registration Number: NCT03250793
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-03
• Study First Submitted QC: 2017-08-11
• Study First Posted: 2017-08-16
• Study Start: 2018-08-20
• Status Verified: 2021-01
• Primary Completion: 2021-01-20
• Study Completion: 2021-01-20
• Last Update Submitted: 2021-01-20
• Last Update Posted: 2021-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Neonate with congenital diaphragmatic hernia	Physiologic study measuring work of breathing which can be estimated by the esophageal and trans-diaphragmatic pressure-time product obtained by an esophageal transducer	Neonates with congenital diaphragmatic hernia in post-surgical period under mechanical ventilation during weaning of mechanical ventilation

Primary Outcome Measures

Name	Time	Method
Work of breathing averaged over 100 consecutive cycles in NAVA ventilation and conventional ventilation	in post-surgical period during 6 hours	Work of breathing is estimated by the esophageal and trans-diaphragmatic pressure-time product obtained by an esophageal transducer

Secondary Outcome Measures

Name	Time	Method
Ventilation parameters: Ti / Ttot ratio in NAVA	through study completion, an average of 1 year	Evolution of the following parameters: peak inspiratory pressure, mean pressure, tidal volume, Ti / Ttot ration, FiO2
Ventilation parameters: Ti / Ttot ratio in conventional ventilation	through study completion, an average of 1 year	Evolution of the following parameters: peak inspiratory pressure, mean pressure, tidal volume, Ti / Ttot ration, FiO2
Ventilation parameters: mean pressure in NAVA	through study completion, an average of 1 year	Evolution of the following parameters: peak inspiratory pressure, mean pressure, tidal volume, Ti / Ttot ration, FiO2
Ventilation parameters: FiO2 in NAVA	through study completion, an average of 1 year	Evolution of the following parameters: peak inspiratory pressure, mean pressure, tidal volume, Ti / Ttot ration, FiO2
Patient-ventilator synchronization in NAVA	through study completion, an average of 1 year	Comparison of the asynchrony indexes between the 2 modes (Number of asynchronies / Number of respiratory cycles)
Patient-ventilator synchronization in conventional ventilation	through study completion, an average of 1 year	Comparison of the asynchrony indexes between the 2 modes (Number of asynchronies / Number of respiratory cycles)
Ventilation parameters: mean pressure in conventional ventilation	through study completion, an average of 1 year	Evolution of the following parameters: peak inspiratory pressure, mean pressure, tidal volume, Ti / Ttot ration, FiO2
Clinical parameters of neonates: heart rate in NAVA	through study completion, an average of 1 year	Evolution of clinical parameters (respiratory rate, heart rate, blood pressure) at the beginning and end of each period
Ventilation parameters: tidal volume in NAVA	through study completion, an average of 1 year	Evolution of the following parameters: peak inspiratory pressure, mean pressure, tidal volume, Ti / Ttot ration, FiO2
Ventilation parameters: peak inspiratory pressure in conventional ventilation	through study completion, an average of 1 year	Evolution of the following parameters: peak inspiratory pressure, mean pressure, tidal volume, Ti / Ttot ration, FiO2
Physiological parameters indirectly evaluating work of breathing: diaphragmatic swing in conventional ventilation	through study completion, an average of 1 year	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.
Gas exchange: measurement of transcutaneous SaO2 in NAVA	through study completion, an average of 1 year	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.
Neonate comfort scores: COMFORT-BEHAVIOR score in NAVA	through study completion, an average of 1 year	Evaluation of comfort (COMFORT-BEHAVIOR scale) at the beginning and at the end of each period.
Dynamic hyperinflation (intrinsic PEEP) in NAVA	through study completion, an average of 1 year	Intrinsic PEEP average over 100 cycles
Dynamic hyperinflation (intrinsic PEEP) in conventional ventilation.	through study completion, an average of 1 year	Intrinsic PEEP average over 100 cycles
Ventilation parameters: peak inspiratory pressure in NAVA	through study completion, an average of 1 year	Evolution of the following parameters: peak inspiratory pressure, mean pressure, tidal volume, Ti / Ttot ration, FiO2
Ventilation parameters: tidal volume in conventional ventilation	through study completion, an average of 1 year	Evolution of the following parameters: peak inspiratory pressure, mean pressure, tidal volume, Ti / Ttot ration, FiO2
Ventilation parameters: FiO2 in conventional ventilation	through study completion, an average of 1 year	Evolution of the following parameters: peak inspiratory pressure, mean pressure, tidal volume, Ti / Ttot ration, FiO2
Physiological parameters indirectly evaluating work of breathing: esophageal swing in NAVA	through study completion, an average of 1 year	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.
Physiological parameters indirectly evaluating work of breathing: diaphragmatic swing in NAVA	through study completion, an average of 1 year	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.
Clinical parameters of neonates: respiratory rate in NAVA	through study completion, an average of 1 year	Evolution of clinical parameters (respiratory rate, heart rate, blood pressure) at the beginning and end of each period
Clinical parameters of neonates: blood pressure in NAVA	through study completion, an average of 1 year	Evolution of clinical parameters (respiratory rate, heart rate, blood pressure) at the beginning and end of each period
Physiological parameters indirectly evaluating work of breathing: esophageal swing in conventional ventilation	through study completion, an average of 1 year	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.
Clinical parameters of neonates: blood pressure in conventional ventilation	through study completion, an average of 1 year	Evolution of clinical parameters (respiratory rate, heart rate, blood pressure) at the beginning and end of each period
Gas exchange: measurement of transcutaneous pCO2 in NAVA	through study completion, an average of 1 year	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.
Gas exchange: measurement of transcutaneous SaO2 in conventional ventilation	through study completion, an average of 1 year	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.
Neonate comfort scores: COMFORT-BEHAVIOR score in conventional ventilation	through study completion, an average of 1 year	Evaluation of comfort (COMFORT-BEHAVIOR scale) at the beginning and at the end of each period.
Clinical parameters of neonates: respiratory rate in conventional ventilation	through study completion, an average of 1 year	Evolution of clinical parameters (respiratory rate, heart rate, blood pressure) at the beginning and end of each period
Clinical parameters of neonates: heart rate in conventional ventilation	through study completion, an average of 1 year	Evolution of clinical parameters (respiratory rate, heart rate, blood pressure) at the beginning and end of each period
Gas exchange: measurement of transcutaneous pCO2 in conventional ventilation	through study completion, an average of 1 year	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.

Trial Locations

Locations (1)

Service de Réanimation Néonatale- Hôpital Femme Mère Enfant- Hospices Civils de Lyon; 🇫🇷 Bron, France