Persistent Pulmonary Hypertension, Mechanical Ventilation Strategies, Neonatal Intensive Care Unit (NICU), Ventilation
Conditions
Keywords
Neonatal Intensive Care Unit, Pressure-Regulated Volume Control, ventilation, Mechanical ventilation strategies
Brief summary
This study aims to assess the clinical and respiratory outcomes of Pressure-Regulated Volume Control ventilation as compared with patient on pressure-controlled ventilation in neonates with persistent pulmonary hypertension.
Detailed description
Persistent pulmonary hypertension of the newborn is a serious and life-threatening condition characterized by sustained elevation of pulmonary vascular resistance leading to right-to-left shunting and severe hypoxemia in neonates Effective management often requires advanced ventilatory support to optimize oxygenation and reduce pulmonary vascular pressures. Mechanical ventilation strategies in neonates with PPHN aim to achieve adequate gas exchange while minimizing ventilator-induced lung injury . Conventional modes such as pressure-controlled ventilation and volume-controlled ventilation have limitations: Pressure-controlled ventilation provides consistent airway pressures but variable tidal volumes, while volume-controlled ventilation delivers stable tidal volumes but may generate injurious peak inspiratory pressures particularly in non-homogeneous lungs. Pressure-Regulated Volume Control is a dual-control ventilation mode that combines the advantages of Pressure-controlled ventilation and Volume Control ventilation by adjusting inspiratory pressures to achieve a set target tidal volume while maintaining the lowest possible airway pressures . This adaptive mode potentially enhances patient-ventilator synchrony, reduces barotrauma and volutrauma and optimizes oxygen delivery in fragile neonatal lungs This study aims to assess the clinical and respiratory outcomes of Pressure-Regulated Volume Control ventilation as compared with patient on pressure-controlled ventilation in neonates with persistent pulmonary hypertension.
Interventions
Group I (Pressure-Controlled Ventilation) will be ventilated using Pressure-Controlled Ventilation mode, in which the inspiratory pressure is manually adjusted to achieve adequate tidal volume and optimal gas exchange while maintaining target oxygenation and ventilation parameters.
DEVICEGroup II (Pressure-Regulated Volume Control)
Group II (PRVC) will be ventilated using Pressure-Regulated Volume Control (PRVC) mode as the primary ventilation strategy. The target tidal volume will be set at 6-8 ml/kg, and the ventilator will automatically regulate inspiratory pressure to achieve this preset tidal volume while minimizing peak airway pressures.
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Days to 2 Months
Healthy volunteers
No
Inclusion criteria
Neonates with confirmed diagnosis of persistent pulmonary hypertension of the newborn (echocardiographic evidence of elevated pulmonary artery pressures) who needed Mechanical ventilation . * Gestational age ≥ 34 weeks. * Requiring mechanical ventilation within the first week of life.
Exclusion criteria
* Neonates with major congenital heart disease (except patent ductus arteriosus or patent foramen ovale). * Severe congenital anomalies (e.g., diaphragmatic hernia, chromosomal abnormalities). * Prior use of high-frequency oscillatory ventilation before enrollment. * Parental refusal to participate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of oxygenation index. | at day 5 of ventilation | The oxygenation index was calculated on each intubated patient for days 1, 3 and 7 using the following formula: mean airway pressure × FIO2/PaO2. |
Secondary
| Measure | Time frame |
|---|---|
| Change in Mean Airway Pressure | At 6, 12, 24, and 48 hours after initiation of ventilation |
Countries
Egypt
Outcome results
None listed