Open Lung Maneuvers During High Frequency Oscillatory Ventilation in Preterm Infants
NCT ID: NCT04289324
Last Updated: 2024-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
36 participants
INTERVENTIONAL
2020-02-25
2025-12-31
Brief Summary
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Detailed Description
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Aim of the study: To assess whether stepwise oxygenation-guided lung recruitment at regular intervals reduces the oxygen saturation index (OSI = Mean Airway Pressure × Fraction of inspired Oxygen × 100 / peripheral Oxygen Saturation, OSI = MAPxFiO2x100/SpO2) averaged over HFOV time in extremely preterm infants.
Study design: Single center randomized controlled study.
Methods: Thirty-six extremely preterm infants below 28 weeks of gestational age and on high frequency oscillation ventilation receive either stepwise oxygenation-guided lung recruitment maneuver at regular intervals (intervention) and upon decision of the care giving team (intervention group) or lung recruitment maneuver only upon decision of the care giving team (standard, control group). The primary outcome is the oxygen saturation index averaged over HFO ventilation time. The observation time of the HFOV will be limited to at most seven days.
Sample size: Fifteen infants need to be enrolled in each group to have 80% power (at a two-sided alpha level of 5%) to detect a difference of 25% in the oxygen saturation index between the intervention group and the control group.
Main outcome variables: Oxygen saturation index averaged over HFO ventilation time.
Secondary outcome variables: Bronchopulmonary dysplasia (BPD); days of ventilation; oxygen saturation index averaged over ventilation time (HFO and conventional ventilation); the following variables measured before, during and after a single stepwise oxygenation-guided recruitment maneuver: echocardiographic parameters, reactance, relative impedance changes, lung ultrasound measurements, transcutaneous partial carbon dioxide (CO2), blood pressure, heart rate.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intervention
lung recruitment maneuvers performed every twelve hours during HFOV
regular lung recruitment
stepwise oxygenation-guided lung recruitment at regular (twelve hours) intervals during high frequency oscillation ventilation
Control
no regular lung recruitment maneuvers during HFOV
No interventions assigned to this group
Interventions
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regular lung recruitment
stepwise oxygenation-guided lung recruitment at regular (twelve hours) intervals during high frequency oscillation ventilation
Eligibility Criteria
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Inclusion Criteria
* not older than 29 weeks of postmenstrual age
* receive HFOV
Exclusion Criteria
* known chromosomal abnormalities
* participation in other intervention trials
8 Weeks
ALL
No
Sponsors
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Medical University of Vienna
OTHER
Responsible Party
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Tobias Werther
Principal Investigator
Principal Investigators
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Tobias Werther
Role: PRINCIPAL_INVESTIGATOR
Medical University of Vienna
Locations
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Medical University of Vienna
Vienna, Vienna, Austria
Countries
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Central Contacts
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Facility Contacts
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References
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Rimensberger PC, Pache JC, McKerlie C, Frndova H, Cox PN. Lung recruitment and lung volume maintenance: a strategy for improving oxygenation and preventing lung injury during both conventional mechanical ventilation and high-frequency oscillation. Intensive Care Med. 2000 Jun;26(6):745-55. doi: 10.1007/s001340051242.
Rimensberger PC, Beghetti M, Hanquinet S, Berner M. First intention high-frequency oscillation with early lung volume optimization improves pulmonary outcome in very low birth weight infants with respiratory distress syndrome. Pediatrics. 2000 Jun;105(6):1202-8. doi: 10.1542/peds.105.6.1202.
De Jaegere A, van Veenendaal MB, Michiels A, van Kaam AH. Lung recruitment using oxygenation during open lung high-frequency ventilation in preterm infants. Am J Respir Crit Care Med. 2006 Sep 15;174(6):639-45. doi: 10.1164/rccm.200603-351OC. Epub 2006 Jun 8.
de Waal K, Evans N, van der Lee J, van Kaam A. Effect of lung recruitment on pulmonary, systemic, and ductal blood flow in preterm infants. J Pediatr. 2009 May;154(5):651-5. doi: 10.1016/j.jpeds.2009.01.012.
Zannin E, Doni D, Ventura ML, Fedeli T, Rigotti C, Dellaca RL, Tagliabue PE. Relationship between Mean Airways Pressure, Lung Mechanics, and Right Ventricular Output during High-Frequency Oscillatory Ventilation in Infants. J Pediatr. 2017 Jan;180:110-115. doi: 10.1016/j.jpeds.2016.09.015. Epub 2016 Oct 10.
Werther T, Kueng E, Aichhorn L, Pummer L, Goeral K, Berger A, Hermon M, Klebermass-Schrehof K. Regular lung recruitment maneuvers during high-frequency oscillatory ventilation in extremely preterm infants: a randomized controlled trial. BMC Pediatr. 2022 Dec 12;22(1):710. doi: 10.1186/s12887-022-03780-7.
Other Identifiers
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1161/2019
Identifier Type: -
Identifier Source: org_study_id
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