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

NCT ID: NCT05493527

Last Updated: 2022-08-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2022-08-30

Brief Summary

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)

Detailed Description

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.

Conditions

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

Study Design

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

Study Groups

noninvasive high frequency oscillatory ventilation (NHFOV)

After documenting parental consent, the ventilated infants eligible for extubation were randomly assigned to NHFOV as post extubation noninvasive respiratory support

Group Type: EXPERIMENTAL

noninvasive high frequency oscillatory ventilation

Intervention Type: DEVICE

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 ventilation (NIPPV)

After documenting parental consent, the ventilated infants eligible for extubation were randomly assigned to NIPPV as post extubation noninvasive respiratory support

Group Type: ACTIVE_COMPARATOR

noninvasive positive pressure ventilation

Intervention Type: DEVICE

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.

Interventions

noninvasive high frequency oscillatory ventilation

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.

Intervention Type: DEVICE

noninvasive positive pressure ventilation

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

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

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Sondos Ahmed Salaheldin Ahmed

Assistant lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Neonatal Intensive Care Units (NICUs), Ain Shams University

Cairo, Abbasia, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Sondos Ahmed

Role: CONTACT

sondosahmedsalah@gmail.com

0109440704 ext. 202

Facility Contacts

Sondos Ahmed

Role: primary

sondosahmed@med.asu.edu.eg

01094407204 ext. 202

Role: backup

sondosahmedsalah@gmail.com

Other Identifiers

MD 90/2020

Identifier Type: -

Identifier Source: org_study_id