Clinical trial NCT04289324: Open Lung Maneuvers During High Frequency Oscillatory Ventilation in Preterm Infants
Official title: Open Lung Maneuvers During High Frequency Oscillatory Ventilation in Extremely Preterm Infants - a Single Center Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: High Frequency Oscillation Ventilation
Extreme Prematurity
Lung Injury, Acute
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2020-02-28
Enrollment: 36
Sex: ALL
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single center randomized controlled study
Primary purpose: TREATMENT

Brief summary: 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 high frequency oscillation ventilation (HFOV) time in extremely preterm infants.

Detailed description: Background: Open lung maneuvers aim to recruit and stabilize the majority of collapsed alveoli, using oxygenation as an indirect variable for lung volume. The stepwise oxygenation-guided lung recruitment procedure during frequency oscillatory ventilation (HFOV) in preterm infants has a low risk of lung hyperinflation and air leak syndrome. Nevertheless, open lung maneuvers at regular intervals during HFOV to maintain or restore oxygenation is not implemented as a routine procedure in the neonatal intensive care.

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.

Eligibility criteria: Inclusion Criteria: Preterm infants

* born below 28 weeks of gestational age
* not older than 29 weeks of postmenstrual age
* receive HFOV

Exclusion Criteria:

* known congenital anomalies of the heart, of the lung, and/or of the central nervous system
* known chromosomal abnormalities
* participation in other intervention trials

Primary outcomes:
measure: HFOV oxygen saturation index
timeFrame: through study completion, an average 10 weeks
Secondary outcomes:
measure: bronchopulmonary dysplasia
timeFrame: through study completion, an average 10 weeks
measure: days of ventilation
timeFrame: through study completion, an average 10 weeks
measure: overall oxygen saturation index
timeFrame: through study completion, an average 10 weeks
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Tobias Werther
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.