Infant, Newborn, Disease, Respiratory Insufficiency
Conditions
Brief summary
This study is a single center, prospective cohort crossover study comparing mechanically ventilated neonates and infants on Neurally Adjusted Ventilatory Assist (NAVA) and synchronized intermittent mandatory ventilation with pressure control plus pressure support (SIMV(PC) + PS) modes. This design will allow for direct comparison of two commonly used ventilator modalities in the neonatal intensive care unit (NICU) to determine if one mode is superior to the other with regards to respiratory mechanics and estimated energy expenditure. It is hypothesized that neonates and infants will have improved respiratory severity score (MAP X FiO2) utilizing NAVA compared to the SIMV (PC) + PS mode but will have increased estimated energy expenditure.
Detailed description
This single center, prospective cohort crossover study will involve mechanically ventilated neonates and infants who are determined to be on stable ventilator settings in either the NAVA or SIMV(PC) + PS modes. This design will allow for direct comparison of two commonly used ventilator modalities in the neonatal intensive care unit (NICU) to determine if one mode is superior to the other with regards to respiratory mechanics and energy expenditure. Infants will be screened for stability criteria including: being stable on the ventilator in either SIMV (PC) + PS or NAVA mode, on weaning or unchanged ventilatory support in previous 12 hours, and no need of escalation of ventilatory pressure or rate in prior 12 hours. After screening criteria is met and consent has been obtained, data will be retrospectively collected for 12 hours prior to randomization. After the subject is randomized, the infant will be stabilized and data will be collected for 12 hours in the randomized mode. Data will then be collected for 12 hours afterwards in the crossover mode. Data will be collected in areas of patient demographics, diagnoses, indications for mechanical ventilation, hemodynamic variables and respiratory parameters. While in each mode, the patient will also have indirect calorimetry obtained to determine estimated energy expenditure of each mode.
Interventions
The subject will be crossed over from the baseline ventilator mode to Neurally Adjusted Ventilatory Assist
DEVICESynchronized Interm. Mandatory Assist
The subject will be crossed over from the baseline ventilator mode to Synchronized Intermittent Mandatory Assist with Pressure Support
Sponsors
Children's Mercy Hospital Kansas City
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 24 Months
Healthy volunteers
No
Inclusion criteria
* Neonates and infants, 22 weeks gestation age or older at birth * Require mechanical ventilation for respiratory support in either SIMV (PC) + PS or NAVA modes * Stable on the ventilator with a fractional inspired oxygen requirement (FiO2) of 0.60 or less. * Stable on the ventilator with weaning or unchanged ventilatory support without need of escalation of ventilatory pressure or rate in prior 12 hours.
Exclusion criteria
* Major congenital anomalies * Neurologic compromise of respiratory drive * Phrenic nerve palsy * Sedated enough to suppress respiratory drive * Respiratory support with volume mechanical ventilation * Respiratory support with high frequency oscillatory ventilation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory Severity Score (MAP X FiO2) | 12 hours and 24 hours | The respiratory severity score will be calculated throughout 24 hour time frame prior to and after study initiation to determine the subject's respiratory severity prior to the randomization, after randomization and after crossover. The respiratory severity score (RSS) is a simplified severity score consisting of the mean airway pressure (MAP) multiplied by the fraction of inspired oxygen (FiO2). This score ranges from 0 to 12, with a higher score indicating more severe disease. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Energy Expenditure | 12 hours and 24 hours | The subject will have indirect calorimetry performed twice during the study on each mode, 12 hours after randomization and 12 hours after crossover to determine the approximate amount of energy expenditure needed for each mode of mechanical ventilation. Energy expenditure is calculated by using the Harris-Benedict equation, resulted in kcal/kg per day. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| NAVA Ventilation First, Then SIMV(PC)PS Ventilation Subject will be randomized to NAVA ventilation first. Intervention is mechanical ventilation with Neurally Adjusted Ventilatory Assist for 12 hours. Subjects will cross over.
Neurally Adjusted Ventilatory Assist: The subject will be crossed over from the baseline ventilator mode to Neurally Adjusted Ventilatory Assist
Synchronized Interm. Mandatory Assist: The subject will be crossed over from the baseline ventilator mode to Synchronized Intermittent Mandatory Assist with Pressure Support | 11 |
| SIMV(PC)PS Ventilation First, Then NAVA Ventilation Subject will be randomized to SIMV(PC)PS ventilation first. Intervention is mechanical ventilation with Synchronized Intermittent Mandatory Assist with Pressure Support for 12 hours. subjects will cross over.
Neurally Adjusted Ventilatory Assist: The subject will be crossed over from the baseline ventilator mode to Neurally Adjusted Ventilatory Assist
Synchronized Interm. Mandatory Assist: The subject will be crossed over from the baseline ventilator mode to Synchronized Intermittent Mandatory Assist with Pressure Support | 11 |
| Total | 22 |
Baseline characteristics
| Characteristic | SIMV(PC)PS Ventilation First, Then NAVA Ventilation | NAVA Ventilation First, Then SIMV(PC)PS Ventilation | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 11 Participants | 11 Participants | 22 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 32 Post Menstral Age in weeks | 32 Post Menstral Age in weeks | 32 Post Menstral Age in weeks |
| Region of Enrollment United States | 11 participants | 11 participants | 22 participants |
| Sex: Female, Male Female | 4 Participants | 5 Participants | 9 Participants |
| Sex: Female, Male Male | 7 Participants | 6 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 11 |
| other Total, other adverse events | 0 / 11 | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 | 0 / 11 |
Outcome results
Primary
Respiratory Severity Score (MAP X FiO2)
The respiratory severity score will be calculated throughout 24 hour time frame prior to and after study initiation to determine the subject's respiratory severity prior to the randomization, after randomization and after crossover. The respiratory severity score (RSS) is a simplified severity score consisting of the mean airway pressure (MAP) multiplied by the fraction of inspired oxygen (FiO2). This score ranges from 0 to 12, with a higher score indicating more severe disease.
Time frame: 12 hours and 24 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NAVA Ventilation First, Then SIMV(PC)PS Ventilation | Respiratory Severity Score (MAP X FiO2) | Respiratory severity score 12 h average | 3.83 score on a scale | Standard Deviation 2 |
| NAVA Ventilation First, Then SIMV(PC)PS Ventilation | Respiratory Severity Score (MAP X FiO2) | Respiratory severity score 24 h average | 3.46 score on a scale | Standard Deviation 2.24 |
| SIMV(PC)PS Ventilation First, Then NAVA Ventilation | Respiratory Severity Score (MAP X FiO2) | Respiratory severity score 24 h average | 3.86 score on a scale | Standard Deviation 1.93 |
| SIMV(PC)PS Ventilation First, Then NAVA Ventilation | Respiratory Severity Score (MAP X FiO2) | Respiratory severity score 12 h average | 3.82 score on a scale | Standard Deviation 1.79 |
Secondary
Energy Expenditure
The subject will have indirect calorimetry performed twice during the study on each mode, 12 hours after randomization and 12 hours after crossover to determine the approximate amount of energy expenditure needed for each mode of mechanical ventilation. Energy expenditure is calculated by using the Harris-Benedict equation, resulted in kcal/kg per day.
Time frame: 12 hours and 24 hours
Population: This outcome measure was not broken down by intervention as it is a median of energy expenditure for all participants enrolled. The data herein are cumulative for all study participants.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| NAVA Ventilation First, Then SIMV(PC)PS Ventilation | Energy Expenditure | 25.6 kcal/kg per day |