Randomized Crossover Study of Neurally Adjusted Ventilatory Assist (NAVA) in Preterm Infants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Han-Suk Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01389882
First received: July 1, 2011
Last updated: January 5, 2012
Last verified: January 2012
  Purpose

The purpose of this study is to test the hypothesis that neurally adjusted ventilatory assist (NAVA) will allow to lower the ventilator pressure at equivalent fractions of inspiratory oxygen (FiO2) and partial pressure of CO2 of capillary blood in preterm infants in comparison with currently used standard ventilation (synchronized intermittent mandatory ventilation with pressure-support ventilation, SIMV+PSV).


Condition Intervention Phase
Infant, Preterm
Procedure: neurally adjusted ventilatory assist (NAVA) ventilator mode
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Application of Neurally Adjusted Ventilatory Assist (NAVA) in Preterm Infants and Assessment of Its Benefits Compared to Synchronized Intermittent Mandatory Ventilation (SIMV) With Pressure Support (PS)

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Peak Inspiratory Pressure [ Time Frame: four hours ] [ Designated as safety issue: No ]
    peak inspiratory pressure measured by a ventilator for 4 hours with each ventilator mode


Secondary Outcome Measures:
  • Mean Airway Pressure [ Time Frame: four hours ] [ Designated as safety issue: No ]
    mean airway pressure measured by a ventilator for 4 hours with each ventilator mode

  • Minute Ventilation [ Time Frame: four hours ] [ Designated as safety issue: No ]
    Minute ventilation measured by a ventilator for 4 hours with each ventilator mode

  • Expiratory Tidal Volume [ Time Frame: four hours ] [ Designated as safety issue: No ]
    Expiratory tidal volume measured by a ventilator for 4 hours with each ventilator mode

  • Dynamic Compliance [ Time Frame: four hours ] [ Designated as safety issue: No ]
    Dynamic Compliance measured by a ventilator for 4 hours with each ventilator mode

  • Work of Breathing [ Time Frame: four hours ] [ Designated as safety issue: No ]
    Work of breathing of patients measured by a ventilator for 4 hours with each ventilator mode

  • Peak EAdi [ Time Frame: four hours ] [ Designated as safety issue: No ]
    Peak electrical activity of the diaphragm

  • Fraction of Oxygen [ Time Frame: four hours ] [ Designated as safety issue: No ]
    Fraction of oxygen measured by a ventilator for 4 hours with each ventilator mode

  • Capillary Blood pH [ Time Frame: four hours ] [ Designated as safety issue: Yes ]
    Capillary blood pH checked immediately after the 4-hour respiratory support with each ventilator mode

  • Capillary Blood pCO2 [ Time Frame: four hours ] [ Designated as safety issue: Yes ]
    Capillary blood pCO2 checked immediately after the 4-hour respiratory support with each ventilator mode

  • Capillary Blood pO2 [ Time Frame: four hours ] [ Designated as safety issue: Yes ]
    Capillary blood pO2 checked immediately after the 4-hour respiratory support with each ventilator mode

  • Capillary Blood HCO3 [ Time Frame: four hours ] [ Designated as safety issue: Yes ]
    Capillary blood HCO3 checked immediately after the 4-hour respiratory support with each ventilator mode


Enrollment: 26
Study Start Date: March 2011
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ventilator assist Procedure: neurally adjusted ventilatory assist (NAVA) ventilator mode
Neurally adjusted ventilatory assist (NAVA) utilizes the electrical activity of the diaphragm (EAdi) to trigger and cycle-off breaths, and therefore presents a means of bypassing the ventilator circuit, and the inherent delays with pneumatic triggering. This is a processed signal, which is not artificially influenced by changes in muscle length, chest wall configuration, and/or lung volume. It represents the summation of muscle motor unit recruitment and/or firing rate, and correlates with phrenic nerve activity. In this mode, the amount of support pressure is coupled with the magnitude of the EAdi. The proportion of support pressure to EAdi (NAVA level) is adjustable.
Other Name: Servo-i (Maquet Critical Care AB, Solna, Sweden)

Detailed Description:

The investigators will apply crossover comparison in preterm infants who received a ventilatory support. In patient whose frequency of mandatory support is under 25, the two ventilatory modes (SIMV+PSV and NAVA) are delivered by the same ventilator (Servo-I; Maquet Critical Care AB, Solna, Sweden) and will set to maintain similar blood gas analysis results.

Determination of the type of ventilatory mode used is performed using a cluster randomization. The randomized order of ventilatory mode will be used during total 9 hours; one mode for 4 hours and another mode for 5 hours. To rule out carry-over effects, a 1-hour interval for washout was guaranteed between modes. Recordings will be obtained over a total 8 hours.

  Eligibility

Ages Eligible for Study:   up to 12 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • preterm infants mechanically ventilated
  • ventilatory set frequency is under 25
  • with informed consent of their parents

Exclusion Criteria:

  • major congenital anomalies
  • patients without self respiratory effort
  • use of sedative or anesthetic drugs
  • grade III or IV intraventricular hemorrhage
  • phrenic nerve palsy or insufficiency
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01389882

Locations
Korea, Republic of
Seoul National University Children's Hospital
Seoul, Korea, Republic of, 110-733
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Han Suk Kim, Ph.D Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Han-Suk Kim, Assist Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01389882     History of Changes
Other Study ID Numbers: VENT-01-NAVA
Study First Received: July 1, 2011
Results First Received: September 18, 2011
Last Updated: January 5, 2012
Health Authority: Korea: Food and Drug Administration
Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:
mechanical ventilation
diaphragm electrical activity
pressure support

ClinicalTrials.gov processed this record on September 30, 2014