Neurally Adjusted Ventilatory Assist and Synchrony in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Effect of Mechanical Ventilation With NAVA and PSV on Inspiratory Muscle Workload and Synchrony in Patients With Chronic Obstructive Pulmonary Disease

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01042080

Acronym

NAVASYNC

Enrollment

Registered

2010-01-05

Start date

2009-12-31

Completion date

2019-09-30

Last updated

2019-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Mechanical ventilation, Neurally adjusted ventilatory assist (NAVA), Acute respiratory failure, Chronic obstructive pulmonary disease, Weaning, Invasive mechanical ventilation, Positive Pressure support Ventilation

Brief summary

NAVA used the electrical activity of the diaphragm (EAdi) to initiate and deliver in proportion of an inspiratory assistance. During inspiration, EAdi signal occurred earlier than airflow or pressure variations in the airway. The investigators hypothesized that NAVA improved patient-ventilator synchrony and reduced inspiratory workload as compared with pressure support ventilation delivered at two different cycling criteria (25 and 50 %).

Interventions

DEVICENAVA

Assisted mechanical ventilation according to the electrical activity of the diaphragm recorded with a 16-FR naso-gastric tube mounted with EMG electrodes

OTHERExpiratory trigger (ET)

Varying the cycling criterion according to the percentage of peak inspiratory flow

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* History of chronic obstructive pulmonary disease * Admitted for acute respiratory failure requiring invasive mechanical ventilation * Currently receiving pressure support ventilation

Exclusion criteria

* Age \< 18 years * Respiratory rate \> 35 bpm * Severe hypoxemia with SpO2 \< 88 % and FIO2 \> 50 % * Heart rate \> 120 bpm * Systolic arterial pressure \< 90 mmHg * Contraindication to naso-gastric tube's insertion

Design outcomes

Primary

Measure	Time frame
Inspiratory muscle workload as reflected by the diaphragmatic Pressure Time Product (PTPdi)	5 minutes

Secondary

Measure	Time frame
Ineffective inspiratory effort	5 minutes
Dynamic intrinsic PEEP	5 minutes
Arterial blood gases	20 minutes
Trigger delay	5 minutes

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026