Bronchopulmonary Dysplasia, Neurally Adjusted Ventilatory Assist, Mechanical Ventilation
Conditions
Keywords
BPD, Bronchopulmonary Dysplasia
Brief summary
This prospective, unblinded, pilot randomized cross-over trial of 2 modes of mechanical ventilation will compare measures of pulmonary mechanics, respiratory gas exchange, and patient comfort between conventional flow triggered mechanical ventilation and neurally adjusted ventilatory assist (NAVA) among 20 prematurely born infants and young children receiving invasive respiratory support for severe bronchopulmonary dysplasia (BPD).
Detailed description
Most research to date in neonatal lung disease has focused on bronchopulmonary dysplasia (BPD) prevention. As a result, insufficient investigation has been performed to define optimal respiratory management strategies for infants and young children with established BPD. Thus, there is no robust evidence base to guide ventilator management to promote lung disease recovery and support neurodevelopment in this population. Neurally adjusted ventilatory assist (NAVA) is an alternative to conventional flow triggered ventilation that has shown promise for improving respiratory gas exchange, patient-ventilator interaction, and work of breathing in preterm neonates. The safety and efficacy of NAVA in infants and young children with established, severe BPD is uncertain. This prospective, unblinded, pilot randomized cross-over trial of 2 modes of mechanical ventilation will compare measures of pulmonary mechanics, respiratory gas exchange, and patient comfort between conventional flow triggered mechanical ventilation and NAVA among 20 prematurely born infants and young children receiving invasive respiratory support for severe BPD.
Interventions
DEVICENAVA
NAVA mode of mechanical ventilation provide the trigger for a spontaneous breath from the diaphragmatic movement instead of diaphragm and allows the patient to control the dynamics of the breath generally set in CMV mode.
DEVICECMV
CMV mode of mechanical ventilation that provides a trigger for a spontaneous breath from the airway flow sensor with dynamics of the breath set as required by the mode
Sponsors
Children's Hospital of Philadelphia
Rhode Island Hospital
Children's Miracle Network
American Respiratory Care Foundation
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, unblinded, pilot randomized cross-over trial of 2 modes of mechanical ventilation
Eligibility
Sex/Gender
ALL
Age
No minimum to 24 Months
Healthy volunteers
No
Inclusion criteria
1. Gestational ages (GA) ≤ 32 weeks 2. Current age between 36 weeks postmenstrual age (PMA) and 2 years corrected age 3. Severe BPD \[as per National Institutes of Health (NIH) consensus definition\] diagnosed at 36 weeks postmenstrual age 4. Receiving invasive mechanical ventilation for ongoing lung disease 5. Not expected to be ready for extubation within 11 days following enrollment 6. Parental consent
Exclusion criteria
1. Severe congenital anomalies 2. Known diaphragmatic defect 3. Current treatment with high frequency mechanical ventilation 4. Do not resuscitate (DNR) Status or Futility of Care 5. \>10% leak around the artificial airway, 6. Treatment with neuromuscular blockade within 72 hours prior to enrollment 7. Acute respiratory instability defined as a ventilator rate increase \> 15 beats per minute (bpm), Positive end-expiratory pressure (PEEP) increase \> 2 cm/water (H2O), sustained FiO2 increase \> 20%, and/or prescribed increase in tidal volume \> 2 mL/kg within 24 hours prior to enrollment will be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oxygen Saturation (SpO2) Index | up to 5 days per study arm | The Oxygenation Saturation Index (OSI) is a composite measure of the severity of hypoxic respiratory failure. It quantifies how much ventilatory support is required to achieve a given level of oxygen saturation. Lower OSI values indicate better oxygenation and better clinical status. Higher OSI values indicate worse oxygenation and more severe respiratory failure. Oxygen saturation index will be measured by assessing if invasive mechanical ventilation with NAVA compared to CMV improves respiratory gas exchange in patients receiving invasive respiratory support for BPD. This will be calculated as the mean, time-weighted daily oxygen saturation (SpO2) index (\[mean airway pressure x Fraction of inspired oxygen (FiO2)\]/SpO2). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sedation Medications | up to 5 days per study arm | The need for sedation medication will be assessed by comparing the needs for sedation by the total daily dose milligram/kilogram (mg/kg) of sedation medications on invasive mechanical ventilation with NAVA compared to CMV. |
| Stress | up to 5 days per study arm | Patient stress will be assessed by collecting salivary swabs three times per day to measure cortisol levels. The daily average will be assessed and compared as a marker for patient stress on invasive mechanical ventilation with NAVA compared to CMV. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORErik Jensen, MD, MSCE
Children's Hospital of Philadelphia
Participant flow
Pre-assignment details
12 subjects were enrolled in the study and 9 completed the study.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized Under 13 months of age | 12 Participants |
| Birth Weight >1000 g | 1 Count of Participants |
| Birth Weight 300-1000 g | 11 Count of Participants |
| Gestational Age at Birth 23-25 weeks | 6 Count of Participants |
| Gestational Age at Birth 26-29 weeks | 6 Count of Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 2 / 12 | 4 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 |
Outcome results
None listed