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

Hernia, DIaphragmatic, Congenital Clinical Trial

— NAVA-DIAPH  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03250793
• Other study ID #: 69HCL17_0429
• Secondary ID: 2017-A02270-53
• Status: Completed
• Phase: N/A
• Start date: August 20, 2018
• Est. completion date: January 20, 2021

Study information

• Verified date: January 2021
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: January 20, 2021
• Est. primary completion date: January 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year and older

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Diaphragmatic
• Hernia, DIaphragmatic, Congenital
• Hernias, Diaphragmatic, Congenital
• Respiratory Aspiration

Intervention

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.

Locations

Country	Name	City	State
France	Service de Réanimation Néonatale- Hôpital Femme Mère Enfant- Hospices Civils de Lyon	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Dynamic hyperinflation (intrinsic PEEP) in NAVA	Intrinsic PEEP average over 100 cycles	through study completion, an average of 1 year
Secondary	Dynamic hyperinflation (intrinsic PEEP) in conventional ventilation.	Intrinsic PEEP average over 100 cycles	through study completion, an average of 1 year
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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