HFOV With Intermittent Sigh Breaths in Neonate: Carbon Dioxide Level

Prince of Songkla University30 enrolled

Overview

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).

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

High-Frequency Ventilation

Interventions

HFOV-sighDEVICE

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.

Eligibility

Sex: ALLMin age: 1 DayMax age: 28 Days

Medical Language ↔ Plain English

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

Locations (1)

Songklanagarind Hospital, Prince of Songkla University

Hat Yai, Changwat Songkhla, Thailand

Outcomes

Primary Outcomes

Arterial pCO2 Level

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.

Time frame: before sigh (baseline) and after sigh (2 hours)

Secondary Outcomes

Oxygenation

oxygen index (oxygen index = mean airway pressure x FiO2 / PaO2), higher scores mean a worse outcome, no unit of scale.

Time frame: before sigh (baseline) and after sigh (2 hours)

Mean Airway Pressure

Mean Airway Pressure (MAP), cmH2O

Time frame: 2 hours after sigh breaths

Data from ClinicalTrials.gov

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