ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 28 for:    Recruiting, Not yet recruiting, Available Studies | "Hernia, Diaphragmatic"
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03250793
Recruitment Status : Not yet recruiting
First Posted : August 16, 2017
Last Update Posted : August 16, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hernia, DIaphragmatic, Congenital 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 Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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.
Estimated Study Start Date : November 1, 2017
Estimated Primary Completion Date : November 1, 2018
Estimated Study Completion Date : November 1, 2018


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.




Primary Outcome Measures :
  1. Work of breathing averaged over 100 consecutive cycles in NAVA ventilation and conventional ventilation [ Time Frame: 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 :
  1. Patient-ventilator synchronization in NAVA [ Time Frame: through study completion, an average of 1 year ]
    Comparison of the asynchrony indexes between the 2 modes (Number of asynchronies / Number of respiratory cycles)

  2. Patient-ventilator synchronization in conventional ventilation [ Time Frame: through study completion, an average of 1 year ]
    Comparison of the asynchrony indexes between the 2 modes (Number of asynchronies / Number of respiratory cycles)

  3. Dynamic hyperinflation (intrinsic PEEP) in NAVA [ Time Frame: through study completion, an average of 1 year ]
    Intrinsic PEEP average over 100 cycles

  4. Dynamic hyperinflation (intrinsic PEEP) in conventional ventilation. [ Time Frame: through study completion, an average of 1 year ]
    Intrinsic PEEP average over 100 cycles

  5. Ventilation parameters: peak inspiratory pressure in NAVA [ Time Frame: through study completion, an average of 1 year ]
    Evolution of the following parameters: peak inspiratory pressure, mean pressure, tidal volume, Ti / Ttot ration, FiO2

  6. Ventilation parameters: mean pressure in NAVA [ Time Frame: through study completion, an average of 1 year ]
    Evolution of the following parameters: peak inspiratory pressure, mean pressure, tidal volume, Ti / Ttot ration, FiO2

  7. Ventilation parameters: tidal volume in NAVA [ Time Frame: through study completion, an average of 1 year ]
    Evolution of the following parameters: peak inspiratory pressure, mean pressure, tidal volume, Ti / Ttot ration, FiO2

  8. Ventilation parameters: Ti / Ttot ratio in NAVA [ Time Frame: through study completion, an average of 1 year ]
    Evolution of the following parameters: peak inspiratory pressure, mean pressure, tidal volume, Ti / Ttot ration, FiO2

  9. Ventilation parameters: FiO2 in NAVA [ Time Frame: through study completion, an average of 1 year ]
    Evolution of the following parameters: peak inspiratory pressure, mean pressure, tidal volume, Ti / Ttot ration, FiO2

  10. Ventilation parameters: peak inspiratory pressure in conventional ventilation [ Time Frame: through study completion, an average of 1 year ]
    Evolution of the following parameters: peak inspiratory pressure, mean pressure, tidal volume, Ti / Ttot ration, FiO2

  11. Ventilation parameters: mean pressure in conventional ventilation [ Time Frame: through study completion, an average of 1 year ]
    Evolution of the following parameters: peak inspiratory pressure, mean pressure, tidal volume, Ti / Ttot ration, FiO2

  12. Ventilation parameters: tidal volume in conventional ventilation [ Time Frame: through study completion, an average of 1 year ]
    Evolution of the following parameters: peak inspiratory pressure, mean pressure, tidal volume, Ti / Ttot ration, FiO2

  13. Ventilation parameters: Ti / Ttot ratio in conventional ventilation [ Time Frame: through study completion, an average of 1 year ]
    Evolution of the following parameters: peak inspiratory pressure, mean pressure, tidal volume, Ti / Ttot ration, FiO2

  14. Ventilation parameters: FiO2 in conventional ventilation [ Time Frame: through study completion, an average of 1 year ]
    Evolution of the following parameters: peak inspiratory pressure, mean pressure, tidal volume, Ti / Ttot ration, FiO2

  15. Physiological parameters indirectly evaluating work of breathing: esophageal swing in NAVA [ Time Frame: 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.

  16. Physiological parameters indirectly evaluating work of breathing: diaphragmatic swing in NAVA [ Time Frame: 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.

  17. Physiological parameters indirectly evaluating work of breathing: esophageal swing in conventional ventilation [ Time Frame: 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.

  18. Physiological parameters indirectly evaluating work of breathing: diaphragmatic swing in conventional ventilation [ Time Frame: 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.

  19. Clinical parameters of neonates: respiratory rate in NAVA [ Time Frame: 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

  20. Clinical parameters of neonates: heart rate in NAVA [ Time Frame: 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

  21. Clinical parameters of neonates: blood pressure in NAVA [ Time Frame: 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

  22. Clinical parameters of neonates: respiratory rate in conventional ventilation [ Time Frame: 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

  23. Clinical parameters of neonates: heart rate in conventional ventilation [ Time Frame: 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

  24. Clinical parameters of neonates: blood pressure in conventional ventilation [ Time Frame: 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

  25. Gas exchange: measurement of transcutaneous SaO2 in NAVA [ Time Frame: 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.

  26. Gas exchange: measurement of transcutaneous pCO2 in NAVA [ Time Frame: 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.

  27. Gas exchange: measurement of transcutaneous pCO2 in conventional ventilation [ Time Frame: 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.

  28. Gas exchange: measurement of transcutaneous SaO2 in conventional ventilation [ Time Frame: 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.

  29. Neonate comfort scores: COMFORT-BEHAVIOR score in NAVA [ Time Frame: through study completion, an average of 1 year ]
    Evaluation of comfort (COMFORT-BEHAVIOR scale) at the beginning and at the end of each period.

  30. Neonate comfort scores: COMFORT-BEHAVIOR score in conventional ventilation [ Time Frame: through study completion, an average of 1 year ]
    Evaluation of comfort (COMFORT-BEHAVIOR scale) at the beginning and at the end of each period.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03250793


Contacts
Contact: Lélia Dreyfus, MD 427855284 ext +33 lelia.dreyfus@gmail.com
Contact: Olivier Claris, MD 427855284 ext +33 olivier.claris@chu-lyon.fr

Locations
France
Service de Réanimation Néonatale- Hôpital Femme Mère Enfant- Hospices Civils de Lyon Not yet recruiting
Bron, France, 69500
Contact: Lélia Dreyfus, MD    427855284 ext +33    lelia.dreyfus@gmail.com   
Contact: Olivier Claris, MD    427855284 ext +33    olivier.claris@chu-lyon.fr   
Principal Investigator: Lélia Dreyfus, MD         
Sub-Investigator: Olivier Claris, MD         
Sub-Investigator: Florent Baudin, MD         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Lélia Dreyfus, MD Service de Réanimation Néonatale- Hôpital Femme Mère Enfant- Hospices Civils de Lyon

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03250793     History of Changes
Other Study ID Numbers: 69HCL17_0429
First Posted: August 16, 2017    Key Record Dates
Last Update Posted: August 16, 2017
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hospices Civils de Lyon:
Hernia, DIaphragmatic, Congenital
Respiration, Artificial
physiologic pilot study
NAVA
Neurally Adjusted Ventilatory Assist
esophageal transducer
Work of Breathing

Additional relevant MeSH terms:
Hernia
Respiratory Aspiration
Hernia, Diaphragmatic
Hernias, Diaphragmatic, Congenital
Pathological Conditions, Anatomical
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Congenital Abnormalities