OPEN4HFOV: Open Lung Maneuvers During High Frequency Oscillatory Ventilation in Preterm Infants
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intervention lung recruitment maneuvers performed every twelve hours during HFOV |
Procedure: regular lung recruitment
stepwise oxygenation-guided lung recruitment at regular (twelve hours) intervals during high frequency oscillation ventilation
|
| No Intervention: Control no regular lung recruitment maneuvers during HFOV |
Outcome Measures
Primary Outcome Measures
- HFOV oxygen saturation index [through study completion, an average 10 weeks]
oxygen saturation index averaged over high frequency oscillation ventilation for not more than seven consecutive days
Secondary Outcome Measures
- bronchopulmonary dysplasia [through study completion, an average 10 weeks]
respiratory support at 36 weeks postmenstrual age
- days of ventilation [through study completion, an average 10 weeks]
days on conventional and high frequency oscillation ventilation
- overall oxygen saturation index [through study completion, an average 10 weeks]
oxygen saturation index averaged over ventilation time
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Medical University of Vienna | Vienna | Austria | 1090 |
Sponsors and Collaborators
- Medical University of Vienna
Investigators
- Principal Investigator: Tobias Werther, Medical University of Vienna
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1161/2019