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

NCT ID: NCT02518230

Last Updated: 2021-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2015-06-30

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.

Conditions

Respiratory Insufficiency; Infant, Newborn, Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Neurally Adjusted Ventilatory Assist

Subject will be randomized to NAVA ventilation. Intervention is mechanical ventilation with Neurally Adjusted Ventilatory Assist for 12 hours.

Group Type: OTHER

Neurally Adjusted Ventilatory Assist

Intervention Type: DEVICE

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

Synchronized Interm. Mandatory Assist

Intervention Type: DEVICE

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.

Group Type: OTHER

Neurally Adjusted Ventilatory Assist

Intervention Type: DEVICE

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

Synchronized Interm. Mandatory Assist

Intervention Type: DEVICE

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

Interventions

Neurally Adjusted Ventilatory Assist

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

Intervention Type: DEVICE

Synchronized Interm. Mandatory Assist

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

Intervention Type: DEVICE

Eligibility 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

• Maximum Eligible Age: 24 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Mercy Hospital Kansas City

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jamie L Rosterman, DO

Role: PRINCIPAL_INVESTIGATOR

Children's Mercy Hospital Kansas City

Locations

Children's Mercy Hospital

Kansas City, Missouri, United States

Countries

United States

References

Rosterman JL, Pallotto EK, Truog WE, Escobar H, Meinert KA, Holmes A, Dai H, Manimtim WM. The impact of neurally adjusted ventilatory assist mode on respiratory severity score and energy expenditure in infants: a randomized crossover trial. J Perinatol. 2018 Jan;38(1):59-63. doi: 10.1038/jp.2017.154. Epub 2017 Oct 26.

Reference Type: DERIVED

PMID: 29072677 (View on PubMed)

Other Identifiers

Crossover NAVA

Identifier Type: -

Identifier Source: org_study_id