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

Primary Purpose

Hernia, DIaphragmatic, Congenital

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Physiologic study measuring work of breathing which can be estimated by the esophageal and trans-diaphragmatic pressure-time product obtained by an esophageal transducer
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hernia, DIaphragmatic, Congenital focused on measuring Hernia, DIaphragmatic, Congenital, Respiration, Artificial, physiologic pilot study, NAVA, Neurally Adjusted Ventilatory Assist, esophageal transducer, Work of Breathing

Eligibility Criteria

1 Year - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Service de Réanimation Néonatale- Hôpital Femme Mère Enfant- Hospices Civils de Lyon

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Neonate with congenital diaphragmatic hernia

Arm Description

Neonates with congenital diaphragmatic hernia in post-surgical period under mechanical ventilation during weaning of mechanical ventilation

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Patient-ventilator synchronization in NAVA
Comparison of the asynchrony indexes between the 2 modes (Number of asynchronies / Number of respiratory cycles)
Patient-ventilator synchronization in conventional ventilation
Comparison of the asynchrony indexes between the 2 modes (Number of asynchronies / Number of respiratory cycles)
Dynamic hyperinflation (intrinsic PEEP) in NAVA
Intrinsic PEEP average over 100 cycles
Dynamic hyperinflation (intrinsic PEEP) in conventional ventilation.
Intrinsic PEEP average over 100 cycles
Ventilation parameters: peak inspiratory pressure in NAVA
Evolution of the following parameters: peak inspiratory pressure, mean pressure, tidal volume, Ti / Ttot ration, FiO2
Ventilation parameters: mean pressure in NAVA
Evolution of the following parameters: peak inspiratory pressure, mean pressure, tidal volume, Ti / Ttot ration, FiO2
Ventilation parameters: tidal volume in NAVA
Evolution of the following parameters: peak inspiratory pressure, mean pressure, tidal volume, Ti / Ttot ration, FiO2
Ventilation parameters: Ti / Ttot ratio in NAVA
Evolution of the following parameters: peak inspiratory pressure, mean pressure, tidal volume, Ti / Ttot ration, FiO2
Ventilation parameters: FiO2 in NAVA
Evolution of the following parameters: peak inspiratory pressure, mean pressure, tidal volume, Ti / Ttot ration, FiO2
Ventilation parameters: peak inspiratory pressure in conventional ventilation
Evolution of the following parameters: peak inspiratory pressure, mean pressure, tidal volume, Ti / Ttot ration, FiO2
Ventilation parameters: mean pressure in conventional ventilation
Evolution of the following parameters: peak inspiratory pressure, mean pressure, tidal volume, Ti / Ttot ration, FiO2
Ventilation parameters: tidal volume in conventional ventilation
Evolution of the following parameters: peak inspiratory pressure, mean pressure, tidal volume, Ti / Ttot ration, FiO2
Ventilation parameters: Ti / Ttot ratio in conventional ventilation
Evolution of the following parameters: peak inspiratory pressure, mean pressure, tidal volume, Ti / Ttot ration, FiO2
Ventilation parameters: FiO2 in conventional ventilation
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
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
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: 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.
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.
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
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
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
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
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
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
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.
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.
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.
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.
Neonate comfort scores: COMFORT-BEHAVIOR score in NAVA
Evaluation of comfort (COMFORT-BEHAVIOR scale) at the beginning and at the end of each period.
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.

Full Information

First Posted
August 3, 2017
Last Updated
January 20, 2021
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT03250793
Brief Title
Work of Breathing Description in Neonates With Congenital Diaphragmatic Hernia in NAVA and in Conventional Ventilation.
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
August 20, 2018 (Actual)
Primary Completion Date
January 20, 2021 (Actual)
Study Completion Date
January 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia, DIaphragmatic, Congenital
Keywords
Hernia, DIaphragmatic, Congenital, Respiration, Artificial, physiologic pilot study, NAVA, Neurally Adjusted Ventilatory Assist, esophageal transducer, Work of Breathing

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neonate with congenital diaphragmatic hernia
Arm Type
Experimental
Arm Description
Neonates with congenital diaphragmatic hernia in post-surgical period under mechanical ventilation during weaning of mechanical ventilation
Intervention Type
Device
Intervention Name(s)
Physiologic study measuring work of breathing which can be estimated by the esophageal and trans-diaphragmatic pressure-time product obtained by an esophageal transducer
Intervention Description
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.
Primary Outcome Measure Information:
Title
Work of breathing averaged over 100 consecutive cycles in NAVA ventilation and conventional ventilation
Description
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
Secondary Outcome Measure Information:
Title
Patient-ventilator synchronization in NAVA
Description
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
Title
Patient-ventilator synchronization in conventional ventilation
Description
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
Title
Dynamic hyperinflation (intrinsic PEEP) in NAVA
Description
Intrinsic PEEP average over 100 cycles
Time Frame
through study completion, an average of 1 year
Title
Dynamic hyperinflation (intrinsic PEEP) in conventional ventilation.
Description
Intrinsic PEEP average over 100 cycles
Time Frame
through study completion, an average of 1 year
Title
Ventilation parameters: peak inspiratory pressure in NAVA
Description
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
Title
Ventilation parameters: mean pressure in NAVA
Description
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
Title
Ventilation parameters: tidal volume in NAVA
Description
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
Title
Ventilation parameters: Ti / Ttot ratio in NAVA
Description
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
Title
Ventilation parameters: FiO2 in NAVA
Description
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
Title
Ventilation parameters: peak inspiratory pressure in conventional ventilation
Description
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
Title
Ventilation parameters: mean pressure in conventional ventilation
Description
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
Title
Ventilation parameters: tidal volume in conventional ventilation
Description
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
Title
Ventilation parameters: Ti / Ttot ratio in conventional ventilation
Description
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
Title
Ventilation parameters: FiO2 in conventional ventilation
Description
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
Title
Physiological parameters indirectly evaluating work of breathing: esophageal swing in NAVA
Description
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
Title
Physiological parameters indirectly evaluating work of breathing: diaphragmatic swing in NAVA
Description
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
Title
Physiological parameters indirectly evaluating work of breathing: esophageal swing in conventional ventilation
Description
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
Title
Physiological parameters indirectly evaluating work of breathing: diaphragmatic swing in conventional ventilation
Description
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
Title
Clinical parameters of neonates: respiratory rate in NAVA
Description
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
Title
Clinical parameters of neonates: heart rate in NAVA
Description
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
Title
Clinical parameters of neonates: blood pressure in NAVA
Description
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
Title
Clinical parameters of neonates: respiratory rate in conventional ventilation
Description
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
Title
Clinical parameters of neonates: heart rate in conventional ventilation
Description
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
Title
Clinical parameters of neonates: blood pressure in conventional ventilation
Description
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
Title
Gas exchange: measurement of transcutaneous SaO2 in NAVA
Description
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
Title
Gas exchange: measurement of transcutaneous pCO2 in NAVA
Description
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
Title
Gas exchange: measurement of transcutaneous pCO2 in conventional ventilation
Description
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
Title
Gas exchange: measurement of transcutaneous SaO2 in conventional ventilation
Description
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
Title
Neonate comfort scores: COMFORT-BEHAVIOR score in NAVA
Description
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
Title
Neonate comfort scores: COMFORT-BEHAVIOR score in conventional ventilation
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lélia Dreyfus, MD
Organizational Affiliation
Service de Réanimation Néonatale- Hôpital Femme Mère Enfant- Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de Réanimation Néonatale- Hôpital Femme Mère Enfant- Hospices Civils de Lyon
City
Bron
ZIP/Postal Code
69500
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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