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

NCT ID: NCT05592431

Last Updated: 2024-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-27
• Study Completion Date: 2024-08-30

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

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

High Frequency Oscillatory Ventilation with Volume Guarantee (HFOV-VG )

After documenting parental consent, preterm neonates with respiratory insufficiency randomly ventilated on (HFOV-VG ) will be assessed by doppler cerebral blood flow velocity measurements

Group Type: EXPERIMENTAL

High Frequency Oscillatory Ventilation with Volume Guarantee (SLE6000;SLE)

Intervention Type: DEVICE

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).

High Frequency Oscillatory Ventilation (HFOV)

After documenting parental consent, preterm neonates with respiratory insufficiency randomly ventilated on (HFOV) will be assessed by doppler cerebral blood flow velocity measurements

Group Type: ACTIVE_COMPARATOR

High Frequency Oscillatory Ventilation (SLE6000;SLE)

Intervention Type: DEVICE

ventilator settings will be recorded such as: inspiratory: expiratory ratio (I:E), fractionated inspired oxygen (FiO2), mean airway pressure (MAP), frequency (HZ), delta P

Interventions

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).

Intervention Type: 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

Intervention Type: DEVICE

Other Intervention Names

transcranial Doppler ultrasonographic examination; transcranial Doppler ultrasonographic examination

Eligibility Criteria

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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 1 Month
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Abdullah Moussa Akid

Assistant lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Neonatal Intensive Care Units (NICUs), Ain Shams University

Cairo, Abbasia, Egypt

Countries

Egypt

Other Identifiers

MD 191/2022

Identifier Type: -

Identifier Source: org_study_id