Work of Breathing Description in Neonates With Congenital Diaphragmatic Hernia in NAVA and in Conventional Ventilation. (NAVA-DIAPH)

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.

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.

Study Overview

• Status: Completed
• Conditions: Hernia, DIaphragmatic, Congenital
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bron, France, 69500
    • Service de Réanimation Néonatale- Hôpital Femme Mère Enfant- Hospices Civils de Lyon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Neonate with congenital diaphragmatic hernia; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	in post-surgical period during 6 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-ventilator synchronization in NAVA	Comparison of the asynchrony indexes between the 2 modes (Number of asynchronies / Number of respiratory cycles)	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)	through study completion, an average of 1 year
Dynamic hyperinflation (intrinsic PEEP) in NAVA	Intrinsic PEEP average over 100 cycles	through study completion, an average of 1 year
Dynamic hyperinflation (intrinsic PEEP) in conventional ventilation.	Intrinsic PEEP average over 100 cycles	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	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	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	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	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	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	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	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	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	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	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.	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.	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.	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.	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	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	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	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	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	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	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.	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.	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.	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.	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.	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.	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Lélia Dreyfus, MD, Service de Réanimation Néonatale- Hôpital Femme Mère Enfant- Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2018
• Primary Completion (Actual): January 20, 2021
• Study Completion (Actual): January 20, 2021

Study Registration Dates

• First Submitted: August 3, 2017
• First Submitted That Met QC Criteria: August 11, 2017
• First Posted (Actual): August 16, 2017

Study Record Updates

• Last Update Posted (Actual): January 22, 2021
• Last Update Submitted That Met QC Criteria: January 20, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: NAVA; Neurally Adjusted Ventilatory Assist; Respiration, Artificial; Hernia, DIaphragmatic, Congenital; physiologic pilot study; esophageal transducer; Work of Breathing
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Congenital Abnormalities; Pathological Conditions, Anatomical; Internal Hernia; Respiratory Aspiration; Hernia; Hernias, Diaphragmatic, Congenital; Hernia, Diaphragmatic
• Other Study ID Numbers: 69HCL17_0429; 2017-A02270-53 (Other Identifier: ID-RCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No