Cerebral Blood Flow, Infant, Premature, Diseases, Respiratory Tract Diseases
Conditions
Keywords
High Frequency Oscillatory Ventilation, Volume Guarantee-High Frequency Oscillatory Ventilation, Preterm, Cerebral Blood Flow
Brief 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
Interventions
DEVICEHigh 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).
DEVICEHigh 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
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Days to 1 Months
Healthy volunteers
No
Inclusion criteria
1. Preterm neonates with gestational age ≤ 35 weeks. 2. Neonates with various causes of respiratory failure: respiratory distress syndrome (RDS), air leak syndromes, pneumonia, or pulmonary hemorrhage, failing with conventional ventilation (i.e. when conventional ventilation failed to maintain either oxygenation or ventilation) and are switched to HFOV as a rescue therapy.
Exclusion criteria
1. Preterm neonates with major upper or lower airway anomalies. 2. Preterm neonates with significant congenital anomalies including cardiac, abdominal or respiratory
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Doppler cerebral blood flow velocity measurements | 72 hours | Investigate the effect of combining the VG mode with HFOV (HFOV-VG), versus the effect of HFOV alone, on Doppler cerebral blood flow velocity measurements |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of admission | 8 weeks or till patient discharged | To document total number of days of admission |
| Mortality rate | 8 weeks or till patient death which comes first | To document incidence of mortality during hospitalization |
| efficiency of HFOV-VG in comparison with HFOV alone | 8 weeks or till patient discharged | Evaluate the efficiency of HFOV-VG in comparison with HFOV alone as a rescue therapy in providing adequate neonatal ventilation and its possible impact on the short-term clinical outcome in terms of mortality and morbidities of these preterm neonates. |
| Days to reach full intake | 8 weeks or till patient discharge which comes first | Number of days needed by each patient to reach full intake |
| Chest x ray change | Before intubation and and after 2 hours on assigned mode | Chest x ray grading of RDS performed to patient before and after the assigned mode to compare lung aeration degree |
| Incidence of feeding intolerance | 8 weeks or till patient discharged | Percentage of Patients who developed feeding intolerance |
Countries
Egypt
Outcome results
None listed