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

History of Changes

Tracking Information

First Received Date ^ICMJE

July 1, 2011

Last Updated Date

January 5, 2012

Start Date ^ICMJE

March 2011

Primary Completion Date

August 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

peak inspiratory pressure [ Time Frame: eight hours ] [ Designated as safety issue: No ]

peak inspiratory pressure measured by a ventilator

Change History

Complete list of historical versions of study NCT01389882 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

all ventilatory parameters [ Time Frame: eight hours ] [ Designated as safety issue: No ]
mean airway pressure, minute ventilatory volume, expiratory tidal volume, fraction of oxygen, work of breathing, dynamic compliance
vital signs [ Time Frame: eight hours ] [ Designated as safety issue: Yes ]
blood pressure(BP), respiratory rates(RR), end-tidal CO2 pressure(EtCO2), transcutaneous SpO2
capillary blood gas analysis results [ Time Frame: eight hours ] [ Designated as safety issue: Yes ]
pH, pCO2, pO2, base excess(BE), HCO3, TCO2

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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)

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).

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 Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care

Condition ^ICMJE

Infant, Preterm

Intervention ^ICMJE

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)

Study Arm (s)

Experimental: ventilator assist

Intervention: Procedure: neurally adjusted ventilatory assist (NAVA) ventilator mode

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

August 2011

Primary Completion Date

August 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

up to 12 Weeks

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT Number ^ICMJE

NCT01389882

Other Study ID Numbers ^ICMJE

VENT-01-NAVA

Has Data Monitoring Committee

Yes

Responsible Party

Han-Suk Kim, Seoul National University Hospital

Study Sponsor ^ICMJE

Seoul National University Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Han Suk Kim, Ph.D

Seoul National University Hospital

Information Provided By

Seoul National University Hospital

Verification Date

January 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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