HFOV With Intermittent Sigh Breaths in Neonate: Carbon Dioxide Level (SighCO2)

Prince of Songkla University

Status: Terminated

Conditions: High-Frequency Ventilation

Treatments: Device: HFOV-sigh

Study type: Interventional

Funder types: Other

Identifiers

NCT05682937

SighPSU

Details and patient eligibility

About

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).

Full 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

Enrollment: 30 patients

Sex: All

Ages: 1 to 28 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

HFOV-sigh mode

Experimental group

Description:

HFOV-sigh setting both brands of ventilator (SLE6000 and Drager Babylog VN500): setting (frequency \[Hz\], mean airway pressure \[MAP\], delta pressure \[dP\]) same as HFOV, set sigh RR 3 breath/min, Sigh inspiratory time \[Ti\] = 1 sec, Sigh peak inspiratory pressure \[PIP\] = (MAP+5, maximum 30) cm H2O, Slope sigh 0.5.

Treatment:

Device: HFOV-sigh