Randomized Crossover of NAVA and Synchronized Intermittent Pressure Ventilation in Neonates and Infants
Respiratory Severity and Caloric Consumption on NAVA: Randomized Crossover Trial of NAVA and SIMV
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.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Missouri
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Kansas City, Missouri, Verenigde Staten, 64108
- Children's Mercy Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Ander: Neurally Adjusted Ventilatory Assist
Subject will be randomized to NAVA ventilation.
Intervention is mechanical ventilation with Neurally Adjusted Ventilatory Assist for 12 hours.
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The subject will be crossed over from the baseline ventilator mode to Neurally Adjusted Ventilatory Assist
The subject will be crossed over from the baseline ventilator mode to Synchronized Intermittent Mandatory Assist with Pressure Support
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Ander: Synchronized Interm. Mandatory Assist
Subject will be randomized to SIMV(PC)PS ventilation.
Intervention is mechanical ventilation with Synchronized Intermittent Mandatory Assist with Pressure Support for 12 hours.
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The subject will be crossed over from the baseline ventilator mode to Neurally Adjusted Ventilatory Assist
The subject will be crossed over from the baseline ventilator mode to Synchronized Intermittent Mandatory Assist with Pressure Support
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Respiratory Severity Score (MAP X FiO2)
Tijdsspanne: 12 hours and 24 hours
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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.
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12 hours and 24 hours
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Energy Expenditure
Tijdsspanne: 12 hours and 24 hours
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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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Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Jamie L Rosterman, DO, Children's Mercy Hospital Kansas City
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- Crossover NAVA
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