Respiratory Insufficiency Clinical Trial
Official title:
Respiratory Severity and Caloric Consumption on NAVA: Randomized Crossover Trial of NAVA and SIMV
NCT number | NCT02518230 |
Other study ID # | Crossover NAVA |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 2014 |
Est. completion date | June 2015 |
Verified date | June 2021 |
Source | Children's Mercy Hospital Kansas City |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 22 |
Est. completion date | June 2015 |
Est. primary completion date | June 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 24 Months |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Children's Mercy Hospital | Kansas City | Missouri |
Lead Sponsor | Collaborator |
---|---|
Children's Mercy Hospital Kansas City |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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. | 12 hours and 24 hours | |
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. |
12 hours and 24 hours |
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