High-Frequency Ventilation, Intermittent Positive-Pressure Ventilation, Newborn Morbidity, Noninvasive Ventilation
Conditions
Keywords
Nasal High-Frequency Oscillation, Nasal Synchronized Intermittent Positive Pressure, Respiratory Failure, Extubation Failure
Brief summary
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.
Detailed description
The primary outcome (pCO2) was measured by crossover RCT. The secondary outcome (reintubation within 7 days) was measured by paralleled RCT.
Interventions
DEVICENon-invasive ventilation
Intervention nasal high frequency oscillatory ventilation (nHFOV) and nasal synchronized intermittent positive pressure ventilation (nSIPPV) were generated by neonatal ventilators (SLE6000 infant ventilators, United Kingdom) using bi-nasal prongs (RAM cannula, NEOTECH®, USA) or the nasal mask of the same type for both ventilation modes. The size of the prongs was determined by the infant's weight. The largest possible prongs were used, with a snug fit to avoid leakage. Pacifier for preterm and term neonate (Jollypop™, USA) was taken to avoid leakage from the mouth. The disposable ventilator circuit (Fisher & Paykel RT268™, Evaqua Dual Limb Infant Breathing Circuit Kit with Evaqua 2 Technology and Pressure Line, Flow \> 4L/min, New Zealand) was used. The initial NIV setting was (7) described in arm description. (above)
Sponsors
Prince of Songkla University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized Controlled Crossover Study
Eligibility
Sex/Gender
ALL
Age
1 Days to 1 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Partial Pressure CO2 (pCO2) : Data From the Crossover Phase of the Study | 2 hours after each intervention | Data from the Crossover Phase of the study: After randomization only in neonate with arterial line, the initial non-invasive ventilation (NIV) was started then blood gas was obtained after 2 hours. The participant was switched to another NIV and blood gas was obtained after 2 hours. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Extubation Failure: Data From the Parallel Phase of the Study. | up to 7 days after each intervention | Data from the Parallel Phase of the study: The participant with and without arterial line was randomized. If The participant with arterial line was randomized to cross-over trial (randomized to NIV, then switched to another NIV for 2 hours, then switched to the first NIV \[parallel trial\]). If The participant without arterial line was randomized to parallel trial. Extubation failure will be defined by reintubation after NIV mode. |
Countries
Thailand
Participant flow
Recruitment details
Overall, 203 neonates were assessed for eligibility
Pre-assignment details
The 133 participants were included in the study.
Participants by arm
| Arm | Count |
|---|---|
| nHFOV, Then nSIPPV, Then nHFOV 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%
Non-invasive ventilation: Intervention nasal high frequency oscillatory ventilation (nHFOV) and nasal synchronized intermittent positive pressure ventilation (nSIPPV) were generated by neonatal ventilators (SLE6000 infant ventilators, United Kingdom) using bi-nasal prongs (RAM cannula, NEOTECH®, USA) or the nasal mask of the same type for both ventilation modes. The size of the prongs was determined by the infant's weight. The largest possible prongs were used, with a snug fit to avoid leakage. Pacifier for preterm and term neonate (Jollypop™, USA) was taken to avoid leakage from the mouth. The disposable ventilator circuit (Fisher & Paykel RT268™, Evaqua Dual Limb Infant Breathing Circuit Kit with Evaqua 2 Technology and Pressure Line, Flow \> 4L/min, New Zealand) was used. The initial NIV setting was (7) described in arm description. (above) | 67 |
| nSIPPV, Then nHFOV, Then nSIPPV 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.
Non-invasive ventilation: Intervention nasal high frequency oscillatory ventilation (nHFOV) and nasal synchronized intermittent positive pressure ventilation (nSIPPV) were generated by neonatal ventilators (SLE6000 infant ventilators, United Kingdom) using bi-nasal prongs (RAM cannula, NEOTECH®, USA) or the nasal mask of the same type for both ventilation modes. The size of the prongs was determined by the infant's weight. The largest possible prongs were used, with a snug fit to avoid leakage. Pacifier for preterm and term neonate (Jollypop™, USA) was taken to avoid leakage from the mouth. The disposable ventilator circuit (Fisher & Paykel RT268™, Evaqua Dual Limb Infant Breathing Circuit Kit with Evaqua 2 Technology and Pressure Line, Flow \> 4L/min, New Zealand) was used. The initial NIV setting was (7) described in arm description. (above) | 66 |
| Total | 133 |
Baseline characteristics
| Characteristic | nHFOV, Then nSIPPV, Then nHFOV | nSIPPV, Then nHFOV, Then nSIPPV | Total |
|---|---|---|---|
| Age, Continuous | 33 weeks | 33 weeks | 33 weeks |
| Duration of invasive ventilation | 63.4 hours | 42.9 hours | 48.4 hours |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 20 Participants | 32 Participants | 52 Participants |
| Sex: Female, Male Male | 47 Participants | 34 Participants | 81 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 67 | 0 / 66 | 0 / 102 | 0 / 102 |
| other Total, other adverse events | 0 / 67 | 0 / 66 | 0 / 102 | 0 / 102 |
| serious Total, serious adverse events | 5 / 67 | 4 / 66 | 0 / 102 | 1 / 102 |
Outcome results
Primary
Partial Pressure CO2 (pCO2) : Data From the Crossover Phase of the Study
Data from the Crossover Phase of the study: After randomization only in neonate with arterial line, the initial non-invasive ventilation (NIV) was started then blood gas was obtained after 2 hours. The participant was switched to another NIV and blood gas was obtained after 2 hours.
Time frame: 2 hours after each intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| nHFO | Partial Pressure CO2 (pCO2) : Data From the Crossover Phase of the Study | 38.7 mm Hg | Standard Deviation 8.8 |
| nSIPPV | Partial Pressure CO2 (pCO2) : Data From the Crossover Phase of the Study | 36.8 mm Hg | Standard Deviation 10.2 |
Secondary
Number of Participants With Extubation Failure: Data From the Parallel Phase of the Study.
Data from the Parallel Phase of the study: The participant with and without arterial line was randomized. If The participant with arterial line was randomized to cross-over trial (randomized to NIV, then switched to another NIV for 2 hours, then switched to the first NIV \[parallel trial\]). If The participant without arterial line was randomized to parallel trial. Extubation failure will be defined by reintubation after NIV mode.
Time frame: up to 7 days after each intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| nHFO | Number of Participants With Extubation Failure: Data From the Parallel Phase of the Study. | 5 Participants |
| nSIPPV | Number of Participants With Extubation Failure: Data From the Parallel Phase of the Study. | 4 Participants |