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SighCO2: HFOV With Intermittent Sigh Breaths in Neonate: CO2 Level

Sponsor
Prince of Songkla University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05682937
Collaborator
(none)
50
Enrollment
1
Location
1
Arm
17.6
Anticipated Duration (Months)
2.8
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Device: HFOV-sigh
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
High Frequency Oscillatory Ventilation Combined With Intermittent Sigh Breaths in Neonate: Effect on Carbon Dioxide Level
Anticipated Study Start Date :
Jan 12, 2023
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Jun 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: HFOV-sigh mode

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.

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. No change in Hz, MAP, delta pressure, and increased FiO2 less than 0.1 occurred between intervention

Outcome Measures

Primary Outcome Measures

  1. Arterial pCO2 level [2 hours]

Secondary Outcome Measures

  1. oxygenation [2 hours]

    oxygen index

Eligibility Criteria

Criteria

Ages Eligible for Study:
0 Days to 28 Days
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Songklanagarind Hospital, Prince of Songkla University Hat-Yai Songkhla Thailand 90110

Sponsors and Collaborators

  • Prince of Songkla University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Anucha Thatrimontrichai, Office of Human Research Ethics Unit, Prince of Songkla University
ClinicalTrials.gov Identifier:
NCT05682937
Other Study ID Numbers:
  • SighPSU
First Posted:
Jan 12, 2023
Last Update Posted:
Jan 13, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Anucha Thatrimontrichai, Office of Human Research Ethics Unit, Prince of Songkla University
Carbon Dioxide
High-Frequency Ventilation
Sigh Breath
Newborn

Study Results

No Results Posted as of Jan 13, 2023