High Frequency Oscillatory Ventilation Combined With Intermittent Sigh Breaths in Neonate: Effect on Carbon Dioxide Level
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Prince of Songkla University
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Arterial pCO2 Level
Study Overview
Brief Summary
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
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 1 Day to 28 Days (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Arterial pCO2 Level
Time Frame: before sigh (baseline) and after sigh (2 hours)
ABL800 BASIC (Radiometer Medical ApS™, Denmark) analyzed all blood gas samples within 1 min after collection. The blood gas machine was auto-calibrated every 4 h by trained specialists every day.
Secondary Outcomes
- Oxygenation(before sigh (baseline) and after sigh (2 hours))
- Mean Airway Pressure(2 hours after sigh breaths)
Investigators
Anucha Thatrimontrichai
Office of Human Research Ethics Unit
Prince of Songkla University