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High-Frequency VentilationSighCO2NCT05682937

HFOV With Intermittent Sigh Breaths in Neonate: Carbon Dioxide Level

A study testing HFOV-sigh in people with High-Frequency Ventilation, run by Prince of Songkla University at 1 site in Thailand.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 1 day to 28 days
Conditions the study is for
High-Frequency Ventilation
What is being tested?
HFOV-sigh
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteThailand
Study dates
12 Jan 2023to 31 Mar 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 day to 28 days
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 10Show fewer
  • 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 locations and contacts

1 site in 1 country.

Thailand1 site

  • Songklanagarind Hospital, Prince of Songkla University

    Hat Yai, Changwat Songkhla, 90110

Other trials in Thailand

About this study

Official title: 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).

Read the 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
Being tested
HFOV-sigh
Keywords
Carbon Dioxide, High-Frequency Ventilation, Sigh Breath, Newborn

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HFOV-sighDevice

    Also called HFOV-sigh application from both brands of ventilator (SLE6000 and Drager Babylog VN500)

    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.

Study groups in NCT05682937
Study groupRoleWhat they receive
HFOV-sigh modeExperimentalHFOV-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.
Receives: Device: HFOV-sigh

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: before sigh (baseline) and after sigh (2 hours)

Secondary outcomes (2)

  1. Oxygenation

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

    Measured: before sigh (baseline) and after sigh (2 hours)

  2. Mean Airway Pressure

    Mean Airway Pressure (MAP), cmH2O

    Measured: 2 hours after sigh breaths

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2023
  2. Study start12 Jan 2023
  3. Primary completion31 Dec 2023
  4. Study completion31 Mar 2024

Why it stopped: The duration of study was planned only 1 year owing to time constraints. Although the targeted sample size was not achieved, but the results showed significant difference between two interventions.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05682937
Sponsor's protocol ID
SighPSU
Acronym
SighCO2
Status last verified
Feb 2025
First submitted
26 Dec 2022
Last updated
21 Feb 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cools F, Askie LM, Offringa M, Asselin JM, Calvert SA, Courtney SE, Dani C, Durand DJ, Gerstmann DR, Henderson-Smart DJ, Marlow N, Peacock JL, Pillow JJ, Soll RF, Thome UH, Truffert P, Schreiber MD, Van Reempts P, Vendettuoli V, Vento G; PreVILIG collaboration. Elective high-frequency oscillatory versus conventional ventilation in preterm infants: a systematic review and meta-analysis of individual patients' data. Lancet. 2010 Jun 12;375(9731):2082-91. doi: 10.1016/S0140-6736(10)60278-4.

    PubMed 20552718

  • Cools F, Offringa M, Askie LM. Elective high frequency oscillatory ventilation versus conventional ventilation for acute pulmonary dysfunction in preterm infants. Cochrane Database Syst Rev. 2015 Mar 19;2015(3):CD000104. doi: 10.1002/14651858.CD000104.pub4.

    PubMed 25785789

  • Courtney SE, Durand DJ, Asselin JM, Hudak ML, Aschner JL, Shoemaker CT; Neonatal Ventilation Study Group. High-frequency oscillatory ventilation versus conventional mechanical ventilation for very-low-birth-weight infants. N Engl J Med. 2002 Aug 29;347(9):643-52. doi: 10.1056/NEJMoa012750.

    PubMed 12200551

  • Hoch B, Bernhard M, Hinsch A. Different patterns of sighs in neonates and young infants. Biol Neonate. 1998;74(1):16-21. doi: 10.1159/000014006.

    PubMed 9657665

  • Jost K, Latzin P, Fouzas S, Proietti E, Delgado-Eckert EW, Frey U, Schulzke SM. Sigh-induced changes of breathing pattern in preterm infants. Physiol Rep. 2015 Nov;3(11):e12613. doi: 10.14814/phy2.12613.

    PubMed 26564066

  • Davis GM, Moscato J. Changes in lung mechanics following sighs in premature newborns without lung disease. Pediatr Pulmonol. 1994 Jan;17(1):26-30. doi: 10.1002/ppul.1950170106.

    PubMed 8108173

  • Qureshi M, Khalil M, Kwiatkowski K, Alvaro RE. Morphology of sighs and their role in the control of breathing in preterm infants, term infants and adults. Neonatology. 2009;96(1):43-9. doi: 10.1159/000201738. Epub 2009 Feb 10.

    PubMed 19204409

  • Patroniti N, Foti G, Cortinovis B, Maggioni E, Bigatello LM, Cereda M, Pesenti A. Sigh improves gas exchange and lung volume in patients with acute respiratory distress syndrome undergoing pressure support ventilation. Anesthesiology. 2002 Apr;96(4):788-94. doi: 10.1097/00000542-200204000-00004.

    PubMed 11964584

  • Mauri T, Eronia N, Abbruzzese C, Marcolin R, Coppadoro A, Spadaro S, Patroniti N, Bellani G, Pesenti A. Effects of Sigh on Regional Lung Strain and Ventilation Heterogeneity in Acute Respiratory Failure Patients Undergoing Assisted Mechanical Ventilation. Crit Care Med. 2015 Sep;43(9):1823-31. doi: 10.1097/CCM.0000000000001083.

    PubMed 25985386

  • Massaro GD, Massaro D. Morphologic evidence that large inflations of the lung stimulate secretion of surfactant. Am Rev Respir Dis. 1983 Feb;127(2):235-6. doi: 10.1164/arrd.1983.127.2.235.

    PubMed 6687518

  • Nacoti M, Spagnolli E, Bonanomi E, Barbanti C, Cereda M, Fumagalli R. Sigh improves gas exchange and respiratory mechanics in children undergoing pressure support after major surgery. Minerva Anestesiol. 2012 Aug;78(8):920-9. Epub 2012 Apr 27.

    PubMed 22531559

  • Bonacina D, Bronco A, Nacoti M, Ferrari F, Fazzi F, Bonanomi E, Bellani G. Pressure support ventilation, sigh adjunct to pressure support ventilation, and neurally adjusted ventilatory assist in infants after cardiac surgery: A physiologic crossover randomized study. Pediatr Pulmonol. 2019 Jul;54(7):1078-1086. doi: 10.1002/ppul.24335. Epub 2019 Apr 19.

    PubMed 31004420

  • Poets CF, Rau GA, Neuber K, Gappa M, Seidenberg J. Determinants of lung volume in spontaneously breathing preterm infants. Am J Respir Crit Care Med. 1997 Feb;155(2):649-53. doi: 10.1164/ajrccm.155.2.9032208.

    PubMed 9032208

  • Sindelar R, Nakanishi H, Stanford AH, Colaizy TT, Klein JM. Respiratory management for extremely premature infants born at 22 to 23 weeks of gestation in proactive centers in Sweden, Japan, and USA. Semin Perinatol. 2022 Feb;46(1):151540. doi: 10.1016/j.semperi.2021.151540. Epub 2021 Nov 10.

    PubMed 34872750

Questions about this trial

What is this clinical trial studying?

A study testing HFOV-sigh in people with High-Frequency Ventilation, run by Prince of Songkla University at 1 site in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Arterial pCO2 Level (time frame: before sigh (baseline) and after sigh (2 hours)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05682937, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2025.

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