MedPath

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

Phase 1
Completed
Conditions
Respiratory Distress Syndrome
Premature Infants
Interventions
Registration Number
NCT04404816
Lead Sponsor
Poznan University of Medical Sciences
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
23
Inclusion Criteria

Not provided

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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)
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Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Group 2helioxpremature infants born \< 33 G.A. with respiratory insufficiency requiring mechanical ventilation, after more than 1 failed extubation attempt
Group 1helioxpremature infants born \< 33 G.A. enrolled in the first 72 hours after birth, with respiratory distress syndrome, requiring non-invasive ventilation with FiO2 \<0.4
Primary Outcome Measures
NameTimeMethod
maximal electric activity of the diaphragm (EaDI max) after 180 minutes of helioxmeasured 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 mixturemeasured 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 mixturemeasured 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).

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 helioxmeasured 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 helioxmeasured 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 helioxmeasured 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 helioxmeasured 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 helioxmeasured 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 helioxmeasured 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 helioxmeasured 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 helioxmeasured 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).

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

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

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

PIP (peak inspiratory pressure) after 15 minutes of helioxmeasured 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 helioxmeasured 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 helioxmeasured 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 mixturemeasured 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.

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 60 minutes of standard mixturemeasured 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 mixturemeasured 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 helioxmeasured 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 helioxmeasured 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 helioxmeasured 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 mixturemeasured 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 mixturemeasured 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.

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

MAP (mean airway pressure) after 15 minutes of helioxmeasured 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 helioxmeasured 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 helioxmeasured 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 60 minutes of standard ventilationmeasured 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 ventilationmeasured 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.

NIV leakage after 15 minutes of helioxmeasured 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.

baseline NIV leakagemeasured 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.

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

NIV leakage after 60 minutes of helioxmeasured 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 helioxmeasured 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 mixturemeasured 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 mixturemeasured 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.

NIV leakage after 180 minutes of standard mixturemeasured 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 Outcome Measures
NameTimeMethod
Cerebral oxygenation after 180 minutes of standard mixturemeasured 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 cerebral oxygenationmeasured 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.

Cerebral oxygenation after 15 minutes of helioxmeasured 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 helioxmeasured 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 helioxmeasured 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 mixturemeasured 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 mixturemeasured 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.

heart rate after 15 minutes of helioxmeasured 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 helioxmeasured 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 helioxmeasured 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 mixturemeasured 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 mixturemeasured 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.

baseline oxygen requirementsrecorded 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 helioxrecorded 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 helioxrecorded 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 helioxrecorded 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 ventilationrecorded 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 ventilationrecorded 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 ventilationrecorded 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

baseline capillary blood gas analysisblood 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 helioxblood 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 mixtureblood 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 ratemeasured 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 180 minutes of standard mixturemeasured 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 saturationmeasured 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 helioxmeasured 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 helioxmeasured 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 helioxmeasured 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 mixturemeasured 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 60 minutes of standard mixturemeasured 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.

oxygen saturation after 180 minutes of standard mixturemeasured 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.

Trial Locations

Locations (1)

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

🇵🇱

Poznań, Great Poland, Poland

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