HFOV With Intermittent Sigh Breaths in Neonate: Carbon Dioxide Level
NCT ID: NCT05682937
Last Updated: 2025-02-21
Study Results
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View full resultsBasic Information
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TERMINATED
NA
30 participants
INTERVENTIONAL
2023-01-12
2024-03-31
Brief Summary
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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).
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Detailed Description
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* 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
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Already ventilated with high frequency ventilation at least 1 hours
* An umbilical or peripheral arterial catheterization was available
Exclusion Criteria
* 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
1 Day
28 Days
ALL
No
Sponsors
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Prince of Songkla University
OTHER
Responsible Party
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Anucha Thatrimontrichai
Office of Human Research Ethics Unit
Principal Investigators
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Anucha Thatrimontrichai, MD
Role: PRINCIPAL_INVESTIGATOR
Prince of Songkla University
Locations
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Songklanagarind Hospital, Prince of Songkla University
Hat Yai, Changwat Songkhla, Thailand
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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SighPSU
Identifier Type: -
Identifier Source: org_study_id
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