Skip to main content
OpenTrials
Completed

NCT Number: NCT04404816

Effects of Non-invasive Ventilation With Helium-oxygen Mixture in Premature Infants With Respiratory Distress Syndrome

The use of a mixture of helium with oxygen (heliox) as a breathing gas may be beneficial due to its unique physical properties, such as low density and high carbon dioxide (CO2) diffusion coefficient. In previous studies in neonates with respiratory failure, conventional ventilation with heliox was associated with improved oxygenation and selected respiratory parameters. The use of heliox may increase the effectiveness of intermittent nasal positive pressure ventilation (NIPPV), but knowledge about the effects of such therapy on newborns is limited.The use of non- invasive neurally adjusted ventilatory assist (NIV-NAVA) allows synchronization and assessment of electrical activity of the diaphragm (EaDI) during heliox administration in premature babies with respiratory failure.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Respiratory Distress Syndrome Female Urogenital Diseases and Pregnancy Complications Lung Diseases Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Premature Infants Respiration Disorders Respiratory Tract Diseases Urogenital Diseases

Age range

1 hour and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Gynecological and obstetric teaching hospital, Departament of Neonatology, Polna street 33

Poznan, Great Poland, 60-535, Poland

About this study

Aim of the study was to assess of the impact of non-invasive ventilation with heliox on respiratory function, diaphragm bioelectrical activity, cerebral oxygenation and selected vital signs in premature neonates with respiratory failure. 23 neonates ≤32 weeks gestational age (GA) were enrolled in the study. Patients were eligible for inclusion when ventilated due to respiratory failure, and in group 1 (n=12) on NIV as primary modality with oxygen requirement of 0.25-0.4 in the first 72 hours of life, or in group 2 (n=11) ready to extubate according to the given criteria. Newborns were ventilated with NIV NAVA and standard breathing gas (air-oxygen) at baseline. Heliox was introduced for 3 hours, followed by 3 hours of air-oxygen. NAVA level was kept constant and pulse oximeter oxygen saturation (SpO2) kept in range of 90-95%. Recorded parameters included heart rate (HR), SpO2 and cerebral tissue oxygenation (StO2). Selected ventilation parameters: peak inspiratory pressure (PIP), positive end-expiratory pressure (PEEP), mean airway pressure (MAP), air leakage during NIV, fraction of inspired oxygen (FiO2) as well as electrical activity of the diaphragm (EaDI mean, minimum and maximum) were also acquired. Blood gas analysis was performed in each period of the study. Statistical analysis was completed with ANOVA Friedman's test and single-factor repeated-measures analysis of variance.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(Group 1):

  • GA under 33 weeks GA
  • Need for NIV due to clinical symptoms of respiratory distress in course of RDS
  • FiO2=0.25-0.4
  • Enrollment within first 72 hours of life
  • Parental consent

Inclusion criteria

(Group 2):

  • GA under 33 weeks GA
  • Need for MV due to clinical symptoms of respiratory distress
  • at least one failed attempted extubation
  • Parental consent

Exclusion criteria

  • Major congenital anomalies
  • Deteriorating pulmonary function despite NIV and the need for intubation and conventional mechanical ventilation (CMV) (Preliminary criteria: pH< 7.22, carbon dioxide partial pressure (pCO2) >65)

Treatment and study plan

Heliox

Drug

NIV-NAVA with a conventional gas mixture (air-oxygen) at baseline, 3 hours of NIV-NAVA with heliox and return to NIV-NAVA with air-oxygen.

Other names: helium-oxygen gas mixture

Primary outcomes

  1. baseline minimal electric activity of the diaphragm (EaDI min)

    Time frame: measured at baseline

    Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI min [mcV, microvolts] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).

  2. baseline mean electric activity of the diaphragm (EaDI mean)

    Time frame: measured at baseline

    Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI mean [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).

  3. baseline maximal electric activity of the diaphragm (EaDI max)

    Time frame: measured at baseline

    Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI max [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).

  4. minimal electric activity of the diaphragm (EaDI min) after 15 minutes of heliox

    Time frame: measured after 15 minutes of heliox ventilation

    Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI min [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).

  5. mean electric activity of the diaphragm (EaDI mean) after 15 minutes of heliox

    Time frame: measured after 15 minutes of heliox ventilation

    Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI mean [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).

  6. maximal electric activity of the diaphragm (EaDI max) after 15 minutes of heliox

    Time frame: measured after 15 minutes of heliox ventilation

    Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI max [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).

  7. minimal electric activity of the diaphragm (EaDI min) after 60 minutes of heliox

    Time frame: measured after 60 minutes of heliox ventilation

    Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI min [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).

  8. mean electric activity of the diaphragm (EaDI mean) after 60 minutes of heliox

    Time frame: measured after 60 minutes of heliox ventilation

    Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI mean [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).

  9. maximal electric activity of the diaphragm (EaDI max) after 60 minutes of heliox

    Time frame: measured after 60 minutes of heliox ventilation

    Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI max [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).

  10. minimal electric activity of the diaphragm (EaDI min) after 180 minutes of heliox

    Time frame: measured after 180 minutes of heliox ventilation

    Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI min [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).

  11. mean electric activity of the diaphragm (EaDI mean) after 180 minutes of heliox

    Time frame: measured after 180 minutes of heliox ventilation

    Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI mean [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).

  12. maximal electric activity of the diaphragm (EaDI max) after 180 minutes of heliox

    Time frame: measured after 180 minutes of heliox ventilation

    Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI max [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).

  13. minimal electric activity of the diaphragm (EaDI min) after 15 minutes of standard mixture

    Time frame: measured after 15 minutes since the return to ventilation with standard mixture

    Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI min [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).

  14. mean electric activity of the diaphragm (EaDI mean) after 15 minutes of standard mixture

    Time frame: measured after 15 minutes since the return to ventilation with standard mixture

    Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI mean [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).

  15. maximal electric activity of the diaphragm (EaDI max) after 15 minutes of standard mixture

    Time frame: measured after 15 minutes since the return to ventilation with standard mixture

    Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI max [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).

  16. minimal electric activity of the diaphragm (EaDI min) after 60 minutes of standard mixture

    Time frame: measured after 60 minutes since the return to ventilation with standard mixture

    Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI min [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).

  17. mean electric activity of the diaphragm (EaDI mean) after 60 minutes of standard mixture

    Time frame: measured after 60 minutes since the return to ventilation with standard mixture

    Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI mean [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).

  18. maximal electric activity of the diaphragm (EaDI max) after 60 minutes of standard mixture

    Time frame: measured after 60 minutes since the return to ventilation with standard mixture

    Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI max [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).

  19. minimal electric activity of the diaphragm (EaDI min) after 180 minutes of standard mixture

    Time frame: measured after 180 minutes since the return to ventilation with standard mixture

    Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI min [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).

  20. mean electric activity of the diaphragm (EaDI mean) after 180 minutes of standard mixture

    Time frame: measured after 180 minutes since the return to ventilation with standard mixture

    Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI mean [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).

  21. maximal electric activity of the diaphragm (EaDI max) after 180 minutes of standard mixture

    Time frame: measured after 180 minutes since the return to ventilation with standard mixture

    Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI max [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).

  22. baseline PIP (peak inspiratory pressure)

    Time frame: measured at baseline

    PIP [cm H2O, centimeters of water] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.

  23. baseline PEEP (positive end-expiratory pressure)

    Time frame: measured at baseline

    PEEP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.

  24. baseline MAP (mean airway pressure)

    Time frame: measured at baseline

    MAP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.

  25. PIP (peak inspiratory pressure) after 15 minutes of heliox

    Time frame: measured after 15 minutes of heliox ventilation

    PIP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.

  26. PIP (peak inspiratory pressure) after 60 minutes of heliox

    Time frame: measured after 60 minutes of heliox ventilation

    PIP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.

  27. PIP (peak inspiratory pressure) after 180 minutes of heliox

    Time frame: measured after 180 minutes of heliox ventilation

    PIP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.

  28. PIP (peak inspiratory pressure) after 15 minutes of standard mixture

    Time frame: measured after 15 minutes since the return to ventilation with standard mixture

    PIP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.

  29. PIP (peak inspiratory pressure) after 60 minutes of standard mixture

    Time frame: measured after 60 minutes since the return to ventilation with standard mixture

    PIP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.

  30. PIP (peak inspiratory pressure) after 180 minutes of standard mixture

    Time frame: measured after 180 minutes since the return to ventilation with standard mixture

    PIP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.

  31. PEEP (positive end-expiratory pressure) after 15 minutes of heliox

    Time frame: measured after 15 minutes of heliox ventilation

    PEEP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.

  32. PEEP (positive end-expiratory pressure) after 60 minutes of heliox

    Time frame: measured after 60 minutes of heliox ventilation

    PEEP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.

  33. PEEP (positive end-expiratory pressure) after 180 minutes of heliox

    Time frame: measured after 180 minutes of heliox ventilation

    PEEP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.

  34. PEEP (positive end-expiratory pressure) after 15 minutes of standard mixture

    Time frame: measured after 15 minutes since the return to ventilation with standard mixture

    PEEP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.

  35. PEEP (positive end-expiratory pressure) after 60 minutes of standard mixture

    Time frame: measured after 60 minutes since the return to ventilation with standard mixture

    PEEP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.

  36. PEEP (positive end-expiratory pressure) after 180 minutes of standard mixture

    Time frame: measured after 180 minutes since the return to ventilation with standard mixture

    PEEP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.

  37. MAP (mean airway pressure) after 15 minutes of heliox

    Time frame: measured after 15 minutes of heliox ventilation

    MAP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.

  38. MAP (mean airway pressure) after 60 minutes of heliox

    Time frame: measured after 60 minutes of heliox ventilation

    MAP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.

  39. MAP (mean airway pressure) after 180 minutes of heliox

    Time frame: measured after 180 minutes of heliox ventilation

    MAP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.

  40. MAP (mean airway pressure) after 15 minutes of standard ventilation

    Time frame: measured after 180 minutes since the return to ventilation with standard mixture

    MAP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.

  41. MAP (mean airway pressure) after 60 minutes of standard ventilation

    Time frame: measured after 60 minutes since the return to ventilation with standard mixture

    MAP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.

  42. MAP (mean airway pressure) after 180 minutes of standard ventilation

    Time frame: measured after 180 minutes since the return to ventilation with standard mixture

    MAP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.

  43. baseline NIV leakage

    Time frame: measured at baseline

    gas leakage fraction [%] during NIV (non-invasive ventilation) recorded by Servo-tracker software their values will be compared between the heliox and air-oxygen NIV.

  44. NIV leakage after 15 minutes of heliox

    Time frame: measured after 15 minutes of heliox ventilation

    gas leakage fraction [%] during NIV (non-invasive ventilation) recorded by Servo-tracker software their values will be compared between the heliox and air-oxygen NIV.

  45. NIV leakage after 60 minutes of heliox

    Time frame: measured after 60 minutes of heliox ventilation

    gas leakage fraction [%] during NIV (non-invasive ventilation) recorded by Servo-tracker software their values will be compared between the heliox and air-oxygen NIV.

  46. NIV leakage after 180 minutes of heliox

    Time frame: measured after 180 minutes of heliox ventilation

    gas leakage fraction [%] during NIV (non-invasive ventilation) recorded by Servo-tracker software their values will be compared between the heliox and air-oxygen NIV.

  47. NIV leakage after 15 minutes of standard mixture

    Time frame: measured after 15 minutes since the return to ventilation with standard mixture

    gas leakage fraction [%] during NIV (non-invasive ventilation) recorded by Servo-tracker software their values will be compared between the heliox and air-oxygen NIV.

  48. NIV leakage after 60 minutes of standard mixture

    Time frame: measured after 60 minutes since the return to ventilation with standard mixture

    gas leakage fraction [%] during NIV (non-invasive ventilation) recorded by Servo-tracker software their values will be compared between the heliox and air-oxygen NIV.

  49. NIV leakage after 180 minutes of standard mixture

    Time frame: measured after 180 minutes since the return to ventilation with standard mixture

    gas leakage fraction [%] during NIV (non-invasive ventilation) recorded by Servo-tracker software their values will be compared between the heliox and air-oxygen NIV.

Secondary outcomes

  1. baseline cerebral oxygenation

    Time frame: measured at baseline

    Cerebral tissue oxygen saturation (StO2; [%]) measured with near infrared spectroscopy (NIRS) - NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA - their values will be compared between the heliox and air-oxygen NIV.

  2. Cerebral oxygenation after 15 minutes of heliox

    Time frame: measured after 15 minutes of heliox ventilation

    Cerebral tissue oxygen saturation (StO2; [%]) measured with near infrared spectroscopy (NIRS) - NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA - their values will be compared between the heliox and air-oxygen NIV.

  3. Cerebral oxygenation after 60 minutes of heliox

    Time frame: measured after 60 minutes of heliox ventilation

    Cerebral tissue oxygen saturation (StO2; [%]) measured with near infrared spectroscopy (NIRS) - NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA - their values will be compared between the heliox and air-oxygen NIV.

  4. Cerebral oxygenation after 180 minutes of heliox

    Time frame: measured after 180 minutes of heliox ventilation

    Cerebral tissue oxygen saturation (StO2; [%]) measured with near infrared spectroscopy (NIRS) - NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA - their values will be compared between the heliox and air-oxygen NIV.

  5. Cerebral oxygenation after 15 minutes of standard mixture

    Time frame: measured after 15 minutes since the return to standard mixture ventilation

    Cerebral tissue oxygen saturation (StO2; [%]) measured with near infrared spectroscopy (NIRS) - NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA - their values will be compared between the heliox and air-oxygen NIV.

  6. Cerebral oxygenation after 60 minutes of standard mixture

    Time frame: measured after 60 minutes since the return to standard mixture ventilation

    Cerebral tissue oxygen saturation (StO2; [%]) measured with near infrared spectroscopy (NIRS) - NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA - their values will be compared between the heliox and air-oxygen NIV.

  7. Cerebral oxygenation after 180 minutes of standard mixture

    Time frame: measured after 180 minutes since the return to standard mixture ventilation

    Cerebral tissue oxygen saturation (StO2; [%]) measured with near infrared spectroscopy (NIRS) - NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA - their values will be compared between the heliox and air-oxygen NIV.

  8. baseline oxygen requirements

    Time frame: recorded at baseline

    Fraction of inspired oxygen (FiO2) will be recorded during heliox and air-oxygen NIV to maintain the saturation assessed by pulse oximetry (SpO2) in 90-95% range; their values will be compared between the phases of the study

  9. oxygen requirements after 15 minutes of heliox

    Time frame: recorded after 15 minutes of heliox ventilation

    Fraction of inspired oxygen (FiO2) will be recorded during heliox and air-oxygen NIV to maintain the saturation assessed by pulse oximetry (SpO2) in 90-95% range; their values will be compared between the phases of the study

  10. oxygen requirements after 60 minutes of heliox

    Time frame: recorded after 60 minutes of heliox ventilation

    Fraction of inspired oxygen (FiO2) will be recorded during heliox and air-oxygen NIV to maintain the saturation assessed by pulse oximetry (SpO2) in 90-95% range; their values will be compared between the phases of the study

  11. oxygen requirements after 180 minutes of heliox

    Time frame: recorded after 180 minutes of heliox ventilation

    Fraction of inspired oxygen (FiO2) will be recorded during heliox and air-oxygen NIV to maintain the saturation assessed by pulse oximetry (SpO2) in 90-95% range; their values will be compared between the phases of the study

  12. oxygen requirements after 15 minutes of standard ventilation

    Time frame: recorded after 15 minutes since the return to standard mixture ventilation

    Fraction of inspired oxygen (FiO2) will be recorded during heliox and air-oxygen NIV to maintain the saturation assessed by pulse oximetry (SpO2) in 90-95% range; their values will be compared between the phases of the study

  13. oxygen requirements after 60 minutes of standard ventilation

    Time frame: recorded after 60 minutes since the return to standard mixture ventilation

    Fraction of inspired oxygen (FiO2) will be recorded during heliox and air-oxygen NIV to maintain the saturation assessed by pulse oximetry (SpO2) in 90-95% range; their values will be compared between the phases of the study

  14. oxygen requirements after 180 minutes of standard ventilation

    Time frame: recorded after 180 minutes since the return to standard mixture ventilation

    Fraction of inspired oxygen (FiO2) will be recorded during heliox and air-oxygen NIV to maintain the saturation assessed by pulse oximetry (SpO2) in 90-95% range; their values will be compared between the phases of the study

  15. baseline capillary blood gas analysis

    Time frame: blood samples drawn at baseline

    Cobas B 221; Roche, Germany; the values will be compared between the heliox and air-oxygen NIV.

  16. capillary blood gas analysis after 3 hours of heliox

    Time frame: blood samples drawn after 3 hours of heliox ventilation

    Cobas B 221; Roche, Germany; the values will be compared between the heliox and air-oxygen NIV.

  17. capillary blood gas analysis after 3 hours of standard mixture

    Time frame: blood samples drawn after 3 hours of standard mixture ventilation

    Cobas B 221; Roche, Germany; the values will be compared between the heliox and air-oxygen NIV.

  18. baseline heart rate

    Time frame: measured at baseline

    heart rate (HR, [bpm / beats per minute]) measured by NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA), values will be compared between the heliox and air-oxygen NIV.

  19. heart rate after 15 minutes of heliox

    Time frame: measured after 15 minutes of heliox ventilation

    heart rate (HR, [bpm / beats per minute]) measured by NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA), values will be compared between the heliox and air-oxygen NIV.

  20. heart rate after 60 minutes of heliox

    Time frame: measured after 60 minutes of heliox ventilation

    heart rate (HR, [bpm / beats per minute]) measured by NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA), values will be compared between the heliox and air-oxygen NIV.

  21. heart rate after 180 minutes of heliox

    Time frame: measured after 180 minutes of heliox ventilation

    heart rate (HR, [bpm / beats per minute]) measured by NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA), values will be compared between the heliox and air-oxygen NIV.

  22. heart rate after 15 minutes of standard mixture

    Time frame: measured after 15 minutes since the return to standard mixture ventilation

    heart rate (HR, [bpm / beats per minute]) measured by NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA), values will be compared between the heliox and air-oxygen NIV.

  23. heart rate after 60 minutes of standard mixture

    Time frame: measured after 60 minutes since the return to standard mixture ventilation

    heart rate (HR, [bpm / beats per minute]) measured by NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA), values will be compared between the heliox and air-oxygen NIV.

  24. heart rate after 180 minutes of standard mixture

    Time frame: measured after 180 minutes since the return to standard mixture ventilation

    heart rate (HR, [bpm / beats per minute]) measured by NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA), values will be compared between the heliox and air-oxygen NIV.

  25. baseline oxygen saturation

    Time frame: measured at baseline

    SpO2 (peripheral capillary oxygen saturation, [%]) measured by NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA) and the values will be compared between the heliox and air-oxygen NIV.

  26. oxygen saturation after 15 minutes of heliox

    Time frame: measured 15 minutes after heliox ventilation

    SpO2 (peripheral capillary oxygen saturation, [%]) measured by NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA) and the values will be compared between the heliox and air-oxygen NIV.

  27. oxygen saturation after 60 minutes of heliox

    Time frame: measured 60 minutes after heliox ventilation

    SpO2 (peripheral capillary oxygen saturation, [%]) measured by NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA) and the values will be compared between the heliox and air-oxygen NIV.

  28. oxygen saturation after 180 minutes of heliox

    Time frame: measured 180 minutes after heliox ventilation

    SpO2 (peripheral capillary oxygen saturation, [%]) measured by NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA) and the values will be compared between the heliox and air-oxygen NIV.

  29. oxygen saturation after 15 minutes of standard mixture

    Time frame: measured 15 minutes since the return to standard mixture ventilation

    SpO2 (peripheral capillary oxygen saturation, [%]) measured by NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA) and the values will be compared between the heliox and air-oxygen NIV.

  30. oxygen saturation after 60 minutes of standard mixture

    Time frame: measured 60 minutes since the return to standard mixture ventilation

    SpO2 (peripheral capillary oxygen saturation, [%]) measured by NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA) and the values will be compared between the heliox and air-oxygen NIV.

  31. oxygen saturation after 180 minutes of standard mixture

    Time frame: measured 180 minutes since the return to standard mixture ventilation

    SpO2 (peripheral capillary oxygen saturation, [%]) measured by NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA) and the values will be compared between the heliox and air-oxygen NIV.

Sponsors and collaborators

Lead sponsor

Poznan University of Medical Sciences

Other

Collaborators

  • European Society for Paediatric Research

Registry information

Official study title

Effects of Non-invasive Ventilation With Helium-oxygen Mixture in Premature Infants With Respiratory Distress Syndrome on Pulmonary Function and Electric Activity of the Diaphragm

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 28, 2020
Registry last updated
Jun 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.