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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.
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HFOV-sigh mode | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HFOV-sigh | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | before sigh (baseline) and after sigh (2 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Oxygenation | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anucha Thatrimontrichai, MD | Prince of Songkla University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Songklanagarind Hospital, Prince of Songkla University | Hat Yai | Changwat Songkhla | 90110 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20552718 | Result | 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. | |
| 25785789 |
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Ninety-four infants were assessed for eligibility; 64 were excluded because of previous or current pulmonary air leaks (n = 3), heterogeneous lung diseases (n = 7), suspected or confirmed grade III-IV intraventricular hemorrhage (n = 1), hemodynamic instability despite using an inotrope (n = 15), PaCO2 level < 45 or > 70 mm Hg before intervention (n = 30), moribund status (n = 7), and parents' decision not to participate (n = 1). Thirty participants were finally enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | mm Hg | before sigh (baseline) and after sigh (2 hours) |
|
|
2 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anucha Thatrimontrichai | Prince of Songkla University | 66 74451257 | tanucha@medicine.psu.ac.th |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 28, 2022 | Sep 14, 2024 | Prot_SAP_000.pdf |
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|
Mean Airway Pressure (MAP), cmH2O
| 2 hours after sigh breaths |
| Result |
| 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. |
| 12200551 | Result | 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. |
| 9657665 | Result | 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. |
| 26564066 | Result | 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. |
| 8108173 | Result | 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. |
| 19204409 | Result | 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. |
| 11964584 | Result | 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. |
| 25985386 | Result | 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. |
| 6687518 | Result | 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. |
| 22531559 | Result | 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. |
| 31004420 | Result | 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. |
| 9032208 | Result | 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. |
| 34872750 | Result | 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. |
| day |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Gestational age | Mean | Standard Deviation | weeks |
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| Birth weight | Mean | Standard Deviation | grams |
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| Secondary | Oxygenation | oxygen index (oxygen index = mean airway pressure x FiO2 / PaO2), higher scores mean a worse outcome, no unit of scale. | oxygen index = mean airway pressure x FiO2 / PaO2 | Posted | Median | Inter-Quartile Range | no unit | before sigh (baseline) and after sigh (2 hours) |
|
|
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| Secondary | Mean Airway Pressure | Mean Airway Pressure (MAP), cmH2O | the frequency of each MAP level was presented by the count of participants | Posted | Count of Participants | Participants | 2 hours after sigh breaths |
|
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| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
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| MAP = 10 cmH2O |
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| MAP = 13 cmH2O |
|