Nasal HFOV Versus Nasal SIPPV in Neonate Following Extubation: RCT Crossover Study (nHFOnSIPPV)

Prince of Songkla University

Status: Completed

Conditions: Noninvasive Ventilation; Newborn Morbidity; Intermittent Positive-Pressure Ventilation; High-Frequency Ventilation

Treatments: Device: Non-invasive ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT04323397

6238211

Details and patient eligibility

About

Mechanical ventilation was introduced to treat respiratory failure in preterm infants or sick neonates then improvements in survival (1,2). However, the complications from short or long term use of ventilation can result in unintended harm or burden (e.g., air leak syndrome, pneumonia, bronchopulmonary dysplasia, neurological injury, retinopathy of prematurity) (3,4). To reduce these risks, clinicians should aggressive extubated neonates as early as possible. Respiratory (focus on blood gas as well as partial pressure CO2 [pCO2]) or extubation (focus on clinical condition as well as reintubation) failure was worrisome in pediatrician and parents if the neonate was reintubated owing to complete recovery of lung disease or inadequate respiratory drive.

Non-invasive ventilation (NIV) was supported for primary respiratory support (initial mode before endotracheal intubation) or post-extubation. Nasal continuous positive airway pressure (nCPAP) was familiar to NIV mode in neonatal respiratory support. Nowadays, the new NIV modalities are nasal intermittent synchronized positive pressure ventilation (nSIPPV) and nasal high frequency oscillation (nHFO). To increase the likelihood of nCPAP success, other new modalities of NIV may be interesting. From theory, nSIPPV and nHFO combines peak inspiratory pressure (PIP) with synchrony and high-frequency oscillations without synchrony above CPAP, respectively. From meta-analysis, nSIPPV and nHFO were statistically significant superior than nCPAP both respiratory and extubation failure in neonate (5,6).

The aim of our study was to investigate the efficacy of nHFOV and nSIPPV for CO2 clearance and reintubation rate after extubated neonates. The investigators hypothesized that nHFOV mode would improve CO2 clearance better than nSIPPV mode.

Full description

The primary outcome (pCO2) was measured by crossover RCT. The secondary outcome (reintubation within 7 days) was measured by paralleled RCT.

Enrollment: 133 patients

Sex: All

Ages: 1 day to 1 month old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Born in hospital and admit in NICU
• The first endotracheal intubation and need NIV if extubation
• Umbilical arterial catheterization to draw the blood gas
• Neonate has not been intervened from another RCT study

Exclusion criteria

• Major congenital anomalies or chromosomal abnormalities
• Neuromuscular diseases
• Upper respiratory tract abnormalities
• Suspected congenital lung diseases or pulmonary hypoplasia
• Need for surgery known before the first extubation
• Grade IV intraventricular hemorrhage occurring before the first extubation
• Palliative care
• Parents' decision not to participate

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

133 participants in 2 patient groups

nasal high frequency oscillatory ventilation

Experimental group

Description:

nHFO: flow 8-10 L/minute, frequency 10 Hz, MAP = "MAP (before extubation) + 2" or "8 (preterm), 10 (term)" cmH2O, dP = "2-3 times of MAP with visible chest oscillations" or 25-35 cmH2O, I:E = 1:1, FiO2 = "FiO2 (before extubation) + 0.1-0.2" keep targeted SpO2 90-94%

Treatment:

Device: Non-invasive ventilation

nasal synchronized intermittent positive pressure ventilation

Experimental group

Description:

nSIPPV: flow 8-10 L/minute, rate 60/minute, PIP = "PIP (before extubation) + 2-5" or "20 (preterm), 25 (term)" cmH2O, PEEP = 5 cmH2O, IT = 0.5 s, FiO2 = "FiO2 (before extubation) + 0.1-0.2" keep targeted SpO2 90-94%. The highest trigger sensitivity avoiding auto triggering was selected.

Treatment:

Device: Non-invasive ventilation