Ignite Creation Date:
2024-05-06 @ 7:21 AM
Last Modification Date:
2024-10-26 @ 11:47 AM
Study NCT ID:
NCT02518230
Status:
COMPLETED
Last Update Posted:
2021-07-23
First Post:
2015-08-03
Brief Title:
Randomized Crossover of NAVA and Synchronized Intermittent Pressure Ventilation in Neonates and Infants
Sponsor:
Childrens Mercy Hospital Kansas City
Organization:
Childrens Mercy Hospital Kansas City
Study Overview
Official Title:
Respiratory Severity and Caloric Consumption on NAVA Randomized Crossover Trial of NAVA and SIMV
Status:
COMPLETED
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 SIMVPC 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
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 SIMVPC 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None