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

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ClinicalTrials.gov Identifier: NCT01389882
Recruitment Status : Completed
First Posted : July 8, 2011
Results First Posted : October 28, 2011
Last Update Posted : January 9, 2012
Sponsor:
Information provided by (Responsible Party):
Han-Suk Kim, Seoul National University Hospital

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Infant, Preterm Procedure: neurally adjusted ventilatory assist (NAVA) ventilator mode Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
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)
Study Start Date : March 2011
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011
Arms and Interventions
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Arm Intervention/treatment
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)


Outcome Measures
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Primary Outcome Measures :
  1. Peak Inspiratory Pressure [ Time Frame: four hours ]
    peak inspiratory pressure measured by a ventilator for 4 hours with each ventilator mode


Secondary Outcome Measures :
  1. Mean Airway Pressure [ Time Frame: four hours ]
    mean airway pressure measured by a ventilator for 4 hours with each ventilator mode

  2. Minute Ventilation [ Time Frame: four hours ]
    Minute ventilation measured by a ventilator for 4 hours with each ventilator mode

  3. Expiratory Tidal Volume [ Time Frame: four hours ]
    Expiratory tidal volume measured by a ventilator for 4 hours with each ventilator mode

  4. Dynamic Compliance [ Time Frame: four hours ]
    Dynamic Compliance measured by a ventilator for 4 hours with each ventilator mode

  5. Work of Breathing [ Time Frame: four hours ]
    Work of breathing of patients measured by a ventilator for 4 hours with each ventilator mode

  6. Peak EAdi [ Time Frame: four hours ]
    Peak electrical activity of the diaphragm

  7. Fraction of Oxygen [ Time Frame: four hours ]
    Fraction of oxygen measured by a ventilator for 4 hours with each ventilator mode

  8. Capillary Blood pH [ Time Frame: four hours ]
    Capillary blood pH checked immediately after the 4-hour respiratory support with each ventilator mode

  9. Capillary Blood pCO2 [ Time Frame: four hours ]
    Capillary blood pCO2 checked immediately after the 4-hour respiratory support with each ventilator mode

  10. Capillary Blood pO2 [ Time Frame: four hours ]
    Capillary blood pO2 checked immediately after the 4-hour respiratory support with each ventilator mode

  11. Capillary Blood HCO3 [ Time Frame: four hours ]
    Capillary blood HCO3 checked immediately after the 4-hour respiratory support with each ventilator mode


Eligibility Criteria
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Ages Eligible for Study:   up to 12 Weeks   (Child)
Sexes Eligible for Study:   All
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
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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): NCT01389882


Locations
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Korea, Republic of
Seoul National University Children's Hospital
Seoul, Korea, Republic of, 110-733
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Han Suk Kim, Ph.D Seoul National University Hospital
More Information
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Responsible Party: Han-Suk Kim, Assist Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01389882    
Other Study ID Numbers: VENT-01-NAVA
First Posted: July 8, 2011    Key Record Dates
Results First Posted: October 28, 2011
Last Update Posted: January 9, 2012
Last Verified: January 2012
Keywords provided by Han-Suk Kim, Seoul National University Hospital:
mechanical ventilation
diaphragm electrical activity
pressure support
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications