An interventional study of HFOV-sigh in High-Frequency Ventilation, sponsored by Prince of Songkla University. Terminated at 1 site in Thailand. Open to participants aged 1 Day to 28 Days. Per ClinicalTrials.gov, last updated 2025-01-29.
Sponsored by Prince of Songkla University · Not applicable, Interventional, and Treatment
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)
Subgroup analysis for
Prince of Songkla University is the lead sponsor of 112 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Also known as: HFOV-sigh application from both brands of ventilator (SLE6000 and Drager Babylog VN500)
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)
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)
| Milestone | HFOV-sigh Mode |
|---|---|
| Started | 30 |
| Completed | 30 |
| Not completed | 0 |
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.
| mm Hg | HFOV-sigh Mode |
|---|---|
| HFOV before sigh | 48.8 ± 3.1 |
| HFOV after sigh | 45.2 ± 6.6 |
oxygen index (oxygen index = mean airway pressure x FiO2 / PaO2), higher scores mean a worse outcome, no unit of scale.
| no unit | HFOV-sigh Mode |
|---|---|
| HFOV before sigh | 3.06 (2.48 to 4.26) |
| HFOV after sigh | 2.95 (2.37 to 3.83) |
Collected over 2 hours. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| HFOV-sigh Mode | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) |
| Age, Continuous(day) | HFOV-sigh Mode |
|---|---|
| Median | 1.88 (0.87 to 3.79) |
| Sex: Female, Male(Participants) | HFOV-sigh Mode |
|---|---|
| Female | 13 |
| Male | 17 |
| Race (NIH/OMB)(Participants) | HFOV-sigh Mode |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 30 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 0 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Gestational age(weeks) | HFOV-sigh Mode |
|---|---|
| Mean | 33.6 ± 4.1 |
| Birth weight(grams) | HFOV-sigh Mode |
|---|---|
| Mean | 2305 ± 853 |
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Plan to share: No
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Prince of Songkla University