NCT05592431

Effect of Volume Guarantee-High Frequency Oscillatory Ventilation on Cerebral Blood Flow in Neonates

Effect of Volume Guarantee-High Frequency Oscillatory Ventilation on Cerebral Blood Flow in Preterm Neonates

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 1 Day – 1 Month
• Healthy volunteers: Not accepted

Summary

A randomized controlled clinical trial evaluates cerebral blood flow changes associated with HFOV-VG in comparison to HFOV alone in preterm neonates with respiratory insufficiency during the period of invasive respiratory support

Detailed description

Neonatal respiratory distress (NRD) is one of the most common problems in the first few days of neonatal life. NRD has been reported to be prevalent in 5 - 29% of the NICU hospitalized neonates. High-frequency oscillatory ventilation (HFOV) has been used for more than three decades, it is a rescue maneuver for failed conventional mechanical ventilation. It delivers small tidal volumes to improve gas exchange. As it uses a low tidal volume, under the anatomical dead space at supra-physiological respiratory frequencies HFOV can reduce the risk of lung injury related to the ventilator and consequently reduce the risk of bronchopulmonary dysplasia HFOV is indicated for patients with neonatal air leak syndrome, persistent pulmonary hypertension, and meconium aspiration Several factors are known to influence cerebral perfusion during HFOV. Hypercapnia increases cerebral blood flow (CBF) while a reduction in PaCO2 leads to cerebral vasoconstriction and decreases CBF, Hypoxia is also known to increase CBF via cerebral vasodilation HFOV with volume guarantee (HFOV-VG) is a promising new ventilator mode for the treatment of respiratory failure in newborns. HFOV-VG is expected to result in less lung injury since it reduces fluctuations of high frequency tidal volume (VThf), reduces the number of out-of-target pCO2 values and provides fewer hypoxia attacks compared with HFOV alone

Conditions

• Infant, Premature, Diseases
• Respiratory Tract Diseases
• Cerebral Blood Flow

Interventions

Type	Name	Description
DEVICE	High Frequency Oscillatory Ventilation with Volume Guarantee (SLE6000;SLE)	ventilator settings will be recorded such as: inspiratory: expiratory ratio (I:E), fractionated inspired oxygen (FiO2), mean airway pressure (MAP), frequency (HZ), delta P and high-frequency tidal volume (VThf).
DEVICE	High Frequency Oscillatory Ventilation (SLE6000;SLE)	ventilator settings will be recorded such as: inspiratory: expiratory ratio (I:E), fractionated inspired oxygen (FiO2), mean airway pressure (MAP), frequency (HZ), delta P

Timeline

• Start date: 2022-10-27
• Primary completion: 2024-05-30
• Completion: 2024-08-30
• First posted: 2022-10-24
• Last updated: 2024-09-25

Locations

1 site across 1 country: Egypt