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

Infant, Preterm Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01389882
• Other study ID #: VENT-01-NAVA
• Status: Completed
• Phase: Phase 2
• First received: July 1, 2011
• Last updated: January 5, 2012
• Start date: March 2011
• Est. completion date: August 2011

Study information

• Verified date: January 2012
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug AdministrationKorea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 12 Weeks

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Infant, Preterm
• Premature Birth

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Children's Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak Inspiratory Pressure	peak inspiratory pressure measured by a ventilator for 4 hours with each ventilator mode	four hours	No
Secondary	Mean Airway Pressure	mean airway pressure measured by a ventilator for 4 hours with each ventilator mode	four hours	No
Secondary	Minute Ventilation	Minute ventilation measured by a ventilator for 4 hours with each ventilator mode	four hours	No
Secondary	Expiratory Tidal Volume	Expiratory tidal volume measured by a ventilator for 4 hours with each ventilator mode	four hours	No
Secondary	Dynamic Compliance	Dynamic Compliance measured by a ventilator for 4 hours with each ventilator mode	four hours	No
Secondary	Work of Breathing	Work of breathing of patients measured by a ventilator for 4 hours with each ventilator mode	four hours	No
Secondary	Peak EAdi	Peak electrical activity of the diaphragm	four hours	No
Secondary	Fraction of Oxygen	Fraction of oxygen measured by a ventilator for 4 hours with each ventilator mode	four hours	No
Secondary	Capillary Blood pH	Capillary blood pH checked immediately after the 4-hour respiratory support with each ventilator mode	four hours	Yes
Secondary	Capillary Blood pCO2	Capillary blood pCO2 checked immediately after the 4-hour respiratory support with each ventilator mode	four hours	Yes
Secondary	Capillary Blood pO2	Capillary blood pO2 checked immediately after the 4-hour respiratory support with each ventilator mode	four hours	Yes
Secondary	Capillary Blood HCO3	Capillary blood HCO3 checked immediately after the 4-hour respiratory support with each ventilator mode	four hours	Yes