Open Lung Maneuvers During High Frequency Oscillatory Ventilation in Preterm Infants

NCT04289324 | Recruiting

• 1 other identifier: 1161/2019
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• bronchopulmonary dysplasia

  through study completion, an average 10 weeks

• days of ventilation

  through study completion, an average 10 weeks

• overall oxygen saturation index

  through study completion, an average 10 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

lung recruitment maneuvers performed every twelve hours during HFOV

Procedure: regular lung recruitment

Control

NO INTERVENTION

no regular lung recruitment maneuvers during HFOV

Interventions

regular lung recruitment PROCEDURE

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

Intervention

Eligibility Criteria

• Age: Up to 8 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, Vienna, 1090, Austria

RECRUITING

Related Publications (6)

• 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.

  PMID: 10945393 BACKGROUND

• 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.

  PMID: 10835058 BACKGROUND

• 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.

  PMID: 16763218 BACKGROUND

• 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.

  PMID: 19364558 BACKGROUND

• 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.

  PMID: 27745747 BACKGROUND

• 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.

  PMID: 36503480 DERIVED

MeSH Terms

Conditions

Acute Lung Injury

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Tobias Werther

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tobias Werther

CONTACT

+4314040032320; tobias.werther@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Single center randomized controlled study

Study Record Dates

• First Submitted: February 25, 2020
• First Posted: February 28, 2020
• Study Start: February 25, 2020
• Primary Completion: August 31, 2025
• Study Completion: December 31, 2025
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)