Noninvasive High Frequency Oscillatory Ventilation as a Post-extubation Respiratory Support in Neonates

Ain Shams University60 enrolled

Overview

A randomized controlled trial comparing Noninvasive high frequency oscillatory ventilation (NHFOV) and Noninvasive positive pressure ventilation (NIPPV) as post-extubation respiratory support in preterm neonates with respiratory distress syndrome(RDS)

The use of noninvasive respiratory support (NRS) has increased in recent decades in Neonatal Intensive Care Unit (NICU) as a means to reduce ventilator-induced lung injury. Various modes of NRS are available and in common use. However despite extensive research, the optimal modality of noninvasive modes remain unknown. Noninvasive high-frequency oscillatory ventilation (NHFOV) is a relatively new mode. It consists of the application of a continuous distending positive pressure with superimposed oscillations. It is a method of augmenting Continuous positive airway pressure (CPAP) support potentially combining the advantages of both high-frequency oscillatory ventilation and CPAP. The new NHFOV technique offers improved carbon dioxide (CO2) removal and increased functional residual capacity. The superimposed oscillations of NHFOV are thought to help avoid gas trapping and upregulate mean airway pressure. This technique is also characterized by lower tidal volume resulting in fewer barotraumas /volutraumas and not needing synchronization. NHFOV was considered a strengthened version of CPAP. The hypothesis is that NHFOV might be superior to NIPPV as a post-extubation respiratory support strategy to avoid reintubation and subsequent complications and/or sequelae in preterm infants.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Infant, Premature, Diseases Infant, Newborn, Disease Respiratory Tract Diseases RDS

Interventions

noninvasive high frequency oscillatory ventilationDEVICE

A time-cycled, pressure-limited, and continuous-flow neonatal ventilator (SLE6000; SLE) was used for neonates assigned to the NHFOV group. The settings were as follows: 1. a frequency of 10 Hertz ( range, 8-12 Hz); 2. an inspiratory time of 50% (1:1) 3. an oscillation amplitude of 35 centimeter of water column (cmH2O) (subsequent regulation range, 20-40 cmH2O) Oscillation amplitude would be regulated according to the level of carbon dioxide(CO2). Visible chest oscillation was not necessary because elimination of CO2 during NHFOV could also occur in the upper respiratory airway dead space 4. Mean airway pressure (MAP) of 10 cm H2O ( range, 7-15) MAP was regulated according to an open lung recruitment strategy 5. fraction of inspired oxygen (FIO2) regulated from 0.21 to 0.40 in order to maintain saturation from 90% to 95% as determined with a pulse oximeter.

noninvasive positive pressure ventilationDEVICE

NIPPV will be delivered by ventilator generating the targeted pressures. Infants will be on: 1. Peep ranging from 5 to 10 cmH2O, 2. Peak inspiratory pressure range 15-25 cmH2O 3. Rate range 40-50 breath/minute 4. FIO2 regulated from 0.21 to 0.40 in order to maintain saturation from 90% to 95% as determined with a pulse oximeter.

Eligibility

Sex: ALLMin age: 1 MinuteMax age: 1 Month

Medical Language ↔ Plain English

Inclusion Criteria: 1. Preterm neonates with gestational age ≤ 35 weeks. 2. Neonates that were on invasive mechanical ventilation for at least 48 hours eligible for extubation Exclusion Criteria: 1. Patients with major upper or lower airway anomalies. 2. Patients with significant congenital anomalies including cardiac, abdominal or respiratory.

Locations (1)

Neonatal Intensive Care Units (NICUs), Ain Shams University

Cairo, Abbasia, Egypt

RECRUITING

Outcomes

Primary Outcomes

Re-intubation rate

Percentage of Patients who failed weaning on the assigned noninvasive mode and needed reintubation to the total number of patients assigned to that mode.

Time frame: 72 hours

Secondary Outcomes

Days on the assigned non-invasive respiratory support

To document number of days on the assigned non-invasive respiratory support

Time frame: 8 weeks or till patient discharge which comes first

Days on supplemental oxygen

To document number of days on supplemental oxygen

Time frame: 8 weeks or till patient discharge which comes first

Duration of admission

To document total number of days of admission

Time frame: 8 weeks or till patient discharge which comes first

Mortality rate

To document incidence of mortality during hospitalization

Time frame: 8 weeks or till patient death which comes first

Lung ultrasound score

lung ultrasound was performed to all patients before extubation and 2 hours after extubation to assess lung aeration. Score ranges from 0 to 18 .Higher score indicates worse lung aeration.

Time frame: Before extubation and after 2 hours on assigned mode

Co2 change

Co2 change in patients on assigned mode using venous blood gases performed before extubation and 2 hours after.

Time frame: Before extubation and after 2 hours on assigned mode

Central Contacts

Sondos Ahmed

CONTACT

0109440704 sondosahmedsalah@gmail.com

Data from ClinicalTrials.gov

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