Clinical trial NCT05682937: HFOV With Intermittent Sigh Breaths in Neonate: Carbon Dioxide Level
Official title: High Frequency Oscillatory Ventilation Combined With Intermittent Sigh Breaths in Neonate: Effect on Carbon Dioxide Level
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: High-Frequency Ventilation
Keywords: Carbon Dioxide
High-Frequency Ventilation
Sigh Breath
Newborn
Lead sponsor: Prince of Songkla University
Sponsor class: OTHER
First posted: 2023-01-12
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Arterial pCO2 Level
timeFrame: before sigh (baseline) and after sigh (2 hours)
Secondary outcomes:
measure: Oxygenation
timeFrame: before sigh (baseline) and after sigh (2 hours)
measure: Mean Airway Pressure
timeFrame: 2 hours after sigh breaths
Other outcomes:
Locations:
city: Hat-Yai
country: Thailand
facility: Songklanagarind Hospital, Prince of Songkla University
state: Songkhla
Study officials:
affiliation: Prince of Songkla University
name: Anucha Thatrimontrichai, MD
role: PRINCIPAL_INVESTIGATOR
References:
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