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Randomized Crossover of NAVA and Synchronized Intermittent Pressure Ventilation in Neonates and Infants

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ClinicalTrials.gov Identifier: NCT02518230
Recruitment Status : Completed
First Posted : August 7, 2015
Last Update Posted : August 7, 2015
Sponsor:
Information provided by (Responsible Party):
Jamie Rosterman, Children's Mercy Hospital Kansas City

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.


Condition or disease Intervention/treatment Phase
Respiratory Insufficiency Infant, Newborn, Disease Device: Neurally Adjusted Ventilatory Assist Device: Synchronized Interm. Mandatory Assist Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Respiratory Severity and Caloric Consumption on NAVA: Randomized Crossover Trial of NAVA and SIMV
Study Start Date : January 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Arm Intervention/treatment
Neurally Adjusted Ventilatory Assist
Subject will be randomized to NAVA ventilation. Intervention is mechanical ventilation with Neurally Adjusted Ventilatory Assist for 12 hours.
Device: Neurally Adjusted Ventilatory Assist
The subject will be crossed over from the baseline ventilator mode to Neurally Adjusted Ventilatory Assist

Device: Synchronized Interm. Mandatory Assist
The subject will be crossed over from the baseline ventilator mode to Synchronized Intermittent Mandatory Assist with Pressure Support

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.
Device: Neurally Adjusted Ventilatory Assist
The subject will be crossed over from the baseline ventilator mode to Neurally Adjusted Ventilatory Assist

Device: Synchronized Interm. Mandatory Assist
The subject will be crossed over from the baseline ventilator mode to Synchronized Intermittent Mandatory Assist with Pressure Support




Primary Outcome Measures :
  1. Respiratory severity score (MAP X FiO2) [ Time Frame: 24 hours ]
    The respiratory severity score will be calculated throughout 4 hour time intervals prior to and after study initiation to determine the subject's respiratory severity prior to the randomization, after randomization and after crossover.


Secondary Outcome Measures :
  1. Energy expenditure [ Time Frame: 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.



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Ages Eligible for Study:   up to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02518230


Locations
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United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
Investigators
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Principal Investigator: Jamie L Rosterman, DO Children's Mercy Hospital Kansas City
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jamie Rosterman, D.O., Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier: NCT02518230    
Other Study ID Numbers: Crossover NAVA
First Posted: August 7, 2015    Key Record Dates
Last Update Posted: August 7, 2015
Last Verified: August 2015
Additional relevant MeSH terms:
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Respiratory Insufficiency
Pulmonary Valve Insufficiency
Infant, Newborn, Diseases
Respiration Disorders
Respiratory Tract Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases