Premature Infants, Respiratory Distress Syndrome
Conditions
Keywords
heliox, respiratory distress syndrome (RDS), non-invasive ventilation, NIRS, EaDI, Edi, NIV, NAVA, helium-oxygen
Brief summary
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.
Detailed description
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.
Interventions
DRUGheliox
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.
Sponsors
European Society for Paediatric Research
Poznan University of Medical Sciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Hours to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NIV leakage after 180 minutes of standard mixture | 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. |
| mean electric activity of the diaphragm (EaDI mean) after 60 minutes of standard mixture | 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). |
| maximal electric activity of the diaphragm (EaDI max) after 60 minutes of standard mixture | 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). |
| minimal electric activity of the diaphragm (EaDI min) after 180 minutes of standard mixture | 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). |
| mean electric activity of the diaphragm (EaDI mean) after 180 minutes of standard mixture | 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). |
| maximal electric activity of the diaphragm (EaDI max) after 180 minutes of standard mixture | 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). |
| baseline PIP (peak inspiratory pressure) | 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. |
| baseline PEEP (positive end-expiratory pressure) | 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. |
| baseline MAP (mean airway pressure) | 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. |
| PIP (peak inspiratory pressure) after 15 minutes of heliox | 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. |
| PIP (peak inspiratory pressure) after 60 minutes of heliox | 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. |
| PIP (peak inspiratory pressure) after 180 minutes of heliox | 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. |
| PIP (peak inspiratory pressure) after 15 minutes of standard mixture | 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. |
| PIP (peak inspiratory pressure) after 60 minutes of standard mixture | 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. |
| PIP (peak inspiratory pressure) after 180 minutes of standard mixture | 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. |
| PEEP (positive end-expiratory pressure) after 15 minutes of heliox | 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. |
| PEEP (positive end-expiratory pressure) after 60 minutes of heliox | 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. |
| PEEP (positive end-expiratory pressure) after 180 minutes of heliox | 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. |
| PEEP (positive end-expiratory pressure) after 15 minutes of standard mixture | 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. |
| PEEP (positive end-expiratory pressure) after 60 minutes of standard mixture | 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. |
| MAP (mean airway pressure) after 15 minutes of heliox | 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. |
| MAP (mean airway pressure) after 60 minutes of heliox | 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. |
| MAP (mean airway pressure) after 180 minutes of heliox | 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. |
| MAP (mean airway pressure) after 15 minutes of standard ventilation | 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. |
| MAP (mean airway pressure) after 60 minutes of standard ventilation | 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. |
| MAP (mean airway pressure) after 180 minutes of standard ventilation | 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. |
| baseline NIV leakage | 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. |
| NIV leakage after 15 minutes of heliox | 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. |
| NIV leakage after 60 minutes of heliox | 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. |
| NIV leakage after 180 minutes of heliox | 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. |
| NIV leakage after 15 minutes of standard mixture | 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. |
| NIV leakage after 60 minutes of standard mixture | 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. |
| PEEP (positive end-expiratory pressure) after 180 minutes of standard mixture | 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. |
| baseline minimal electric activity of the diaphragm (EaDI min) | 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). |
| baseline mean electric activity of the diaphragm (EaDI mean) | 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). |
| baseline maximal electric activity of the diaphragm (EaDI max) | 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). |
| minimal electric activity of the diaphragm (EaDI min) after 15 minutes of heliox | 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). |
| mean electric activity of the diaphragm (EaDI mean) after 15 minutes of heliox | 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). |
| maximal electric activity of the diaphragm (EaDI max) after 15 minutes of heliox | 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). |
| minimal electric activity of the diaphragm (EaDI min) after 60 minutes of heliox | 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). |
| mean electric activity of the diaphragm (EaDI mean) after 60 minutes of heliox | 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). |
| maximal electric activity of the diaphragm (EaDI max) after 60 minutes of heliox | 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). |
| minimal electric activity of the diaphragm (EaDI min) after 180 minutes of heliox | 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). |
| mean electric activity of the diaphragm (EaDI mean) after 180 minutes of heliox | 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). |
| maximal electric activity of the diaphragm (EaDI max) after 180 minutes of heliox | 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). |
| minimal electric activity of the diaphragm (EaDI min) after 15 minutes of standard mixture | 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). |
| mean electric activity of the diaphragm (EaDI mean) after 15 minutes of standard mixture | 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). |
| maximal electric activity of the diaphragm (EaDI max) after 15 minutes of standard mixture | 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). |
| minimal electric activity of the diaphragm (EaDI min) after 60 minutes of standard mixture | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cerebral oxygenation after 15 minutes of heliox | 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. |
| Cerebral oxygenation after 60 minutes of heliox | 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. |
| Cerebral oxygenation after 180 minutes of heliox | 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. |
| Cerebral oxygenation after 15 minutes of standard mixture | 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. |
| Cerebral oxygenation after 60 minutes of standard mixture | 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. |
| Cerebral oxygenation after 180 minutes of standard mixture | 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. |
| baseline oxygen requirements | 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 |
| oxygen requirements after 15 minutes of heliox | 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 |
| oxygen requirements after 60 minutes of heliox | 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 |
| oxygen requirements after 180 minutes of heliox | 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 |
| oxygen requirements after 15 minutes of standard ventilation | 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 |
| oxygen requirements after 60 minutes of standard ventilation | 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 |
| oxygen requirements after 180 minutes of standard ventilation | 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 |
| oxygen saturation after 60 minutes of standard mixture | 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. |
| baseline capillary blood gas analysis | blood samples drawn at baseline | Cobas B 221; Roche, Germany; the values will be compared between the heliox and air-oxygen NIV. |
| capillary blood gas analysis after 3 hours of heliox | 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. |
| capillary blood gas analysis after 3 hours of standard mixture | 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. |
| baseline heart rate | 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. |
| heart rate after 15 minutes of heliox | 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. |
| heart rate after 60 minutes of heliox | 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. |
| heart rate after 180 minutes of heliox | 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. |
| heart rate after 15 minutes of standard mixture | 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. |
| heart rate after 60 minutes of standard mixture | 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. |
| heart rate after 180 minutes of standard mixture | 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. |
| baseline oxygen saturation | 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. |
| oxygen saturation after 15 minutes of heliox | 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. |
| oxygen saturation after 60 minutes of heliox | 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. |
| oxygen saturation after 180 minutes of heliox | 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. |
| oxygen saturation after 15 minutes of standard mixture | 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. |
| oxygen saturation after 180 minutes of standard mixture | 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. |
| baseline cerebral oxygenation | 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. |
Countries
Poland
Outcome results
None listed