High-Frequency Ventilation
Conditions
Keywords
Carbon Dioxide, High-Frequency Ventilation, Sigh Breath, Newborn
Brief summary
The goal of this clinical trial is to the short-term effects of sigh breaths during High-frequency oscillatory ventilation (HFOV) in neonate undergoing mechanical ventilation. From meta-analysis, It revealed HFOV in neonates could reduce chronic lung disease or death rather than conventional ventilation. The main question it aims to answer is: Do sigh breaths augment restoring lung volume and ventilation (CO2 level) in intubated neonate with HFOV? Participants will be applied sigh breaths (HFOV-sigh) during on HFOV. Researchers will compare HFOV-sigh mode to see if CO2 level (before-after intervention).
Detailed description
Sample size calculation (before and after intervention: two dependent mean) * alpha = 0.05, beta = 0.2, * Delta = 1.9, SD. = 4.35 * Calculated sample size = 42 * increase sample size if loss follow up 20% * Final sample size (n) = 50 Subgroup analysis for * preterm neonates * very preterm or very low birth weight neonates * extremely preterm or extremely low birth weight neonates
Interventions
DEVICEHFOV-sigh
HFOV-sigh setting both SLE6000 and Drager Babylog VN500: setting (Hz, MAP, delta pressure) same as HFOV, set sigh RR 3 breath/min, Sigh Ti = 1 sec, Sigh PIP = (MAP+5, maximum 30) cm H2O, Slope sigh 0.5.
Sponsors
Prince of Songkla University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Days to 28 Days
Healthy volunteers
No
Inclusion criteria
* Preterm and term neonate (gestational age 24-41 weeks) with postnatal age less than 28 days * Already ventilated with high frequency ventilation at least 1 hours * An umbilical or peripheral arterial catheterization was available
Exclusion criteria
* Previous or current pulmonary air leaks (pulmonary interstitial emphysema, pneumothorax, pneumomediastinum, and pneumopericardium) * Heterogeneous lung disease including MAS, congenital diaphragmatic hernia * Suspected lung hypoplasia * Suspected or confirmed intraventricular hemorrhage grade III-IV * Suspected or confirmed hypoxic ischemic encephalopathy or 5-min Apgar score less than 3 * Hemodynamic instability despite using inotrope(s) * Arterial pCO2 level less than 45 mm Hg or more than 70 mm Hg before intervention * Need a new arterial puncture for samples both before and after interventions * Moribund status * Parents' decision not to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Arterial pCO2 Level | before sigh (baseline) and after sigh (2 hours) | ABL800 BASIC (Radiometer Medical ApS™, Denmark) analyzed all blood gas samples within 1 min after collection. The blood gas machine was auto-calibrated every 4 h by trained specialists every day. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oxygenation | before sigh (baseline) and after sigh (2 hours) | oxygen index (oxygen index = mean airway pressure x FiO2 / PaO2), higher scores mean a worse outcome, no unit of scale. |
| Mean Airway Pressure | 2 hours after sigh breaths | Mean Airway Pressure (MAP), cmH2O |
Countries
Thailand
Participant flow
Pre-assignment details
Ninety-four infants were assessed for eligibility; 64 were excluded because of previous or current pulmonary air leaks (n = 3), heterogeneous lung diseases (n = 7), suspected or confirmed grade III-IV intraventricular hemorrhage (n = 1), hemodynamic instability despite using an inotrope (n = 15), PaCO2 level \< 45 or \> 70 mm Hg before intervention (n = 30), moribund status (n = 7), and parents' decision not to participate (n = 1). Thirty participants were finally enrolled.
Participants by arm
| Arm | Count |
|---|---|
| HFOV-sigh Mode HFOV-sigh setting both SLE6000 and Drager Babylog VN500: setting (Hz, MAP, delta pressure) same as HFOV, set sigh RR 3 breath/min, Sigh Ti = 1 sec, Sigh PIP = (MAP+5, maximum 30) cm H2O, Slope sigh 0.5. | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | HFOV-sigh Mode |
|---|---|
| Age, Continuous | 1.88 day |
| Birth weight | 2305 grams STANDARD_DEVIATION 853 |
| Gestational age | 33.6 weeks STANDARD_DEVIATION 4.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 30 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
Arterial pCO2 Level
ABL800 BASIC (Radiometer Medical ApS™, Denmark) analyzed all blood gas samples within 1 min after collection. The blood gas machine was auto-calibrated every 4 h by trained specialists every day.
Time frame: before sigh (baseline) and after sigh (2 hours)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HFOV-sigh Mode | Arterial pCO2 Level | HFOV before sigh | 48.8 mm Hg | Standard Deviation 3.1 |
| HFOV-sigh Mode | Arterial pCO2 Level | HFOV after sigh | 45.2 mm Hg | Standard Deviation 6.6 |
Secondary
Mean Airway Pressure
Mean Airway Pressure (MAP), cmH2O
Time frame: 2 hours after sigh breaths
Population: the frequency of each MAP level was presented by the count of participants
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HFOV-sigh Mode | Mean Airway Pressure | MAP = 7 cmH2O | 5 Participants |
| HFOV-sigh Mode | Mean Airway Pressure | MAP = 8 cmH2O | 12 Participants |
| HFOV-sigh Mode | Mean Airway Pressure | MAP = 9 cmH2O | 8 Participants |
| HFOV-sigh Mode | Mean Airway Pressure | MAP = 10 cmH2O | 4 Participants |
| HFOV-sigh Mode | Mean Airway Pressure | MAP = 13 cmH2O | 1 Participants |
Secondary
Oxygenation
oxygen index (oxygen index = mean airway pressure x FiO2 / PaO2), higher scores mean a worse outcome, no unit of scale.
Time frame: before sigh (baseline) and after sigh (2 hours)
Population: oxygen index = mean airway pressure x FiO2 / PaO2
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HFOV-sigh Mode | Oxygenation | HFOV before sigh | 3.06 no unit |
| HFOV-sigh Mode | Oxygenation | HFOV after sigh | 2.95 no unit |