Open Lung Maneuvers During High Frequency Oscillatory Ventilation in Preterm Infants

Extreme Prematurity Clinical Trial

— OPEN4HFOV  

Official title:

Open Lung Maneuvers During High Frequency Oscillatory Ventilation in Extremely Preterm Infants - A Single Center Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04289324
• Other study ID #: 1161/2019
• Status: Recruiting
• Phase: N/A
• Start date: February 25, 2020
• Est. completion date: June 30, 2024

Study information

• Verified date: October 2023
• Source: Medical University of Vienna
• Contact: Tobias Werther
• Phone: +4314040032320
• Email: tobias.werther[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: June 30, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 8 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Extreme Prematurity
• High Frequency Oscillation Ventilation
• Lung Injury
• Lung Injury, Acute

Intervention

Procedure:
• regular lung recruitment
stepwise oxygenation-guided lung recruitment at regular (twelve hours) intervals during high frequency oscillation ventilation

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

References & Publications (5)

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 Ju — View 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. — View 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): — View 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. Intensi — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HFOV oxygen saturation index	oxygen saturation index averaged over high frequency oscillation ventilation for not more than seven consecutive days	through study completion, an average 10 weeks
Secondary	bronchopulmonary dysplasia	respiratory support at 36 weeks postmenstrual age	through study completion, an average 10 weeks
Secondary	days of ventilation	days on conventional and high frequency oscillation ventilation	through study completion, an average 10 weeks
Secondary	overall oxygen saturation index	oxygen saturation index averaged over ventilation time	through study completion, an average 10 weeks