HFOV With Intermittent Sigh Breaths in Neonate: CO2 Level — SighCO2  

High-Frequency Ventilation Clinical Trial

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

Status Enrolling by invitation

Clinical Trial 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).

Clinical Trial 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 ;

Related Conditions & MeSH terms

• High-Frequency Ventilation

• NCT number: NCT05682937
• Study type: Interventional
• Source: Prince of Songkla University
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 12, 2023
• Completion date: June 30, 2024