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

February 2, 2025 updated by: Anucha Thatrimontrichai, Prince of Songkla University

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

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Songkhla
      • Hat-Yai, Songkhla, Thailand, 90110
        • Songklanagarind Hospital, Prince of Songkla University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 4 weeks (Child)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HFOV-sigh mode
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.
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.
Other Names:
  • HFOV-sigh application from both brands of ventilator (SLE6000 and Drager Babylog VN500)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Arterial pCO2 Level
Time Frame: 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.
before sigh (baseline) and after sigh (2 hours)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxygenation
Time Frame: 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.
before sigh (baseline) and after sigh (2 hours)
Mean Airway Pressure
Time Frame: 2 hours after sigh breaths
Mean Airway Pressure (MAP), cmH2O
2 hours after sigh breaths

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prince of Songkla University

Investigators

  • Principal Investigator: Anucha Thatrimontrichai, MD, Prince of Songkla University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2023

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

March 31, 2024

Study Registration Dates

First Submitted

December 26, 2022

First Submitted That Met QC Criteria

January 11, 2023

First Posted (Actual)

January 12, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 2, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SighPSU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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