Overview

This trial is active, not recruiting.

Condition chronic obstructive pulmonary disease
Treatments nava, expiratory trigger (et)
Sponsor Hôpital Européen Marseille
Start date December 2009
End date April 2011
Trial size 15 participants
Trial identifier NCT01042080, 2009-A01099-48

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 %).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking open label
Primary purpose supportive care
Arm
(Active Comparator)
Pressure support ventilation with expiratory trigger set at 25 %.
expiratory trigger (et)
Varying the cycling criterion according to the percentage of peak inspiratory flow
(Active Comparator)
Pressure support ventilation with expiratory cycling set at 50 %.
expiratory trigger (et)
Varying the cycling criterion according to the percentage of peak inspiratory flow
(Experimental)
NAVA level is adjusted to achieve similar peak inspiratory pressure levels than during PSV.
nava Neurally Adjusted Ventilatory Assist
Assisted mechanical ventilation according to the electrical activity of the diaphragm recorded with a 16-FR naso-gastric tube mounted with EMG electrodes

Primary Outcomes

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

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Effect of Mechanical Ventilation With NAVA and PSV on Inspiratory Muscle Workload and Synchrony in Patients With Chronic Obstructive Pulmonary Disease
Principal investigator Jérôme ALLARDET-SERVENT, MD, MSc
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Hôpital Européen Marseille.