NCT05682937

HFOV With Intermittent Sigh Breaths in Neonate: Carbon Dioxide Level

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Prince of Songkla University · Academic / Other
• Sex: All
• Age: 1 Day – 28 Days
• Healthy volunteers: Not accepted

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

Conditions

• High-Frequency Ventilation

Interventions

Type	Name	Description
DEVICE	HFOV-sigh	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.

Timeline

• Start date: 2023-01-12
• Primary completion: 2023-12-31
• Completion: 2024-03-31
• First posted: 2023-01-12
• Last updated: 2025-02-21
• Results posted: 2025-01-29

Locations

1 site across 1 country: Thailand