HFOV With Intermittent Sigh Breaths in Neonate: Carbon Dioxide Level

Not Applicable

Terminated

• Conditions: High-Frequency Ventilation
• Interventions: Device: HFOV-sigh

• Registration Number: NCT05682937
• Lead Sponsor: Prince of Songkla University

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 Timeline

• Study First Submitted: 2022-12-26
• Study First Submitted QC: 2023-01-11
• Study Start: 2023-01-12
• Study First Posted: 2023-01-12
• Primary Completion: 2023-12-31
• Study Completion: 2024-03-31
• Results First Submitted: 2024-09-14
• Results First Submitted QC: 2025-01-03
• Results First Posted: 2025-01-29
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-02
• Last Update Posted: 2025-02-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HFOV-sigh mode	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. No change in Hz, MAP, delta pressure, and increased FiO2 less than 0.1 occurred between intervention.

Primary Outcome Measures

Name	Time	Method
Arterial pCO2 Level	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 Outcome Measures

Name	Time	Method
Oxygenation	before sigh (baseline) and after sigh (2 hours)	oxygen index (oxygen index = mean airway pressure x FiO2 / PaO2), higher scores mean a worse outcome, no unit of scale.
Mean Airway Pressure	2 hours after sigh breaths	Mean Airway Pressure (MAP), cmH2O

Trial Locations

Locations (1)

Songklanagarind Hospital, Prince of Songkla University; 🇹🇭 Hat-Yai, Songkhla, Thailand