HFOV With Intermittent Sigh Breaths in Neonate: Carbon Dioxide Level

NCT05682937 | Terminated Results DMC

• 1 other identifier: SighPSU
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

High-Frequency Ventilation

Keywords

Carbon Dioxide; High-Frequency Ventilation; Sigh Breath; Newborn

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (2)

• Oxygenation

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

• Mean Airway Pressure

  2 hours after sigh breaths

Study Arms (1)

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.

Device: HFOV-sigh

Interventions

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.

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

HFOV-sigh mode

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prince of Songkla University: lead

Study Sites (1)

Songklanagarind Hospital, Prince of Songkla University

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

Related Publications (14)

• 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.

  PMID: 20552718 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.

  PMID: 25785789 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.

  PMID: 12200551 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.

  PMID: 9657665 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.

  PMID: 26564066 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.

  PMID: 8108173 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.

  PMID: 19204409 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.

  PMID: 11964584 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.

  PMID: 25985386 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.

  PMID: 6687518 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.

  PMID: 22531559 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.

  PMID: 31004420 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.

  PMID: 9032208 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.

  PMID: 34872750 RESULT

Results Point of Contact

• Title: Anucha Thatrimontrichai
• Organization: Prince of Songkla University

tanucha@medicine.psu.ac.th

66 74451257

Study Officials

• Anucha Thatrimontrichai, MD

  Prince of Songkla University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Office of Human Research Ethics Unit

Study Record Dates

• First Submitted: December 26, 2022
• First Posted: January 12, 2023
• Study Start: January 12, 2023
• Primary Completion: December 31, 2023
• Study Completion: March 31, 2024
• Last Updated: February 21, 2025
• Results First Posted: January 29, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)