HFOV With Intermittent Sigh Breaths in Neonate: CO2 Level

Study Overview
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Brief Summary
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The goal of this clinical trial is to the short-term effects of sigh breaths during High-frequency oscillatory ventilation (HFOV) in neonate undergoing mechanical ventilation. From meta-analysis, It revealed HFOV in neonates could reduce chronic lung disease or death rather than conventional ventilation. The main question it aims to answer is: Do sigh breaths augment restoring lung volume and ventilation (CO2 level) in intubated neonate with HFOV? Participants will be applied sigh breaths (HFOV-sigh) during on HFOV. Researchers will compare HFOV-sigh mode to see if CO2 level (before-after intervention).

Detailed Description
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Sample size calculation (before and after intervention: two dependent mean) alpha = 0.05, beta = 0.2, Delta = 1.9, SD. = 4.35 Calculated sample size = 42 increase sample size if loss follow up 20% Final sample size (n) = 50 Subgroup analysis for preterm neonates very preterm or very low birth weight neonates extremely preterm or extremely low birth weight neonates

Official Title
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High Frequency Oscillatory Ventilation Combined With Intermittent Sigh Breaths in Neonate: Effect on Carbon Dioxide Level

Conditions
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High-Frequency Ventilation

Intervention / Treatment
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* Device: HFOV-sigh


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Preterm and term neonate (gestational age 24-41 weeks) with postnatal age less than 28 days Already ventilated with high frequency ventilation at least 1 hours An umbilical or peripheral arterial catheterization was available Exclusion Criteria: Previous or current pulmonary air leaks (pulmonary interstitial emphysema, pneumothorax, pneumomediastinum, and pneumopericardium) Heterogeneous lung disease including MAS, congenital diaphragmatic hernia Suspected lung hypoplasia Suspected or confirmed intraventricular hemorrhage grade III-IV Suspected or confirmed hypoxic ischemic encephalopathy or 5-min Apgar score less than 3 Hemodynamic instability despite using inotrope(s) Arterial pCO2 level less than 45 mm Hg or more than 70 mm Hg before intervention Need a new arterial puncture for samples both before and after interventions Moribund status Parents' decision not to participate

Ages Eligible for Study
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Minimum Age: 0 Days
Maximum Age: 28 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HFOV-sigh mode<br>HFOV-sigh setting both SLE6000 and Drager Babylog VN500: setting (Hz, MAP, delta pressure) same as HFOV, set sigh RR 3 breath/min, Sigh Ti = 1 sec, Sigh PIP = (MAP+5, maximum 30) cm H2O, Slope sigh 0.5. No change in Hz, MAP, delta pressure, and increased FiO2 less than 0.1 occurred between intervention. | Device: HFOV-sigh<br>* HFOV-sigh setting both SLE6000 and Drager Babylog VN500: setting (Hz, MAP, delta pressure) same as HFOV, set sigh RR 3 breath/min, Sigh Ti = 1 sec, Sigh PIP = (MAP+5, maximum 30) cm H2O, Slope sigh 0.5. No change in Hz, MAP, delta pressure, and increased FiO2 less than 0.1 occurred between intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arterial pCO2 level |  | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oxygenation | oxygen index | 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Carbon Dioxide, High-Frequency Ventilation, Sigh Breath, Newborn