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

September 3, 2019 updated by: Jerome Allardet-Servent, MD, Hôpital Européen Marseille

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

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 %).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Marseille, France, 13002
        • Hopital Paul Desbief
      • Marseille, France, 13006
        • Fondation Hôpital Ambroise Paré

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: PSV-ET 25
Pressure support ventilation with expiratory trigger set at 25 %.
Other: Expiratory trigger (ET)
Varying the cycling criterion according to the percentage of peak inspiratory flow
Active Comparator: PSV-ET 50
Pressure support ventilation with expiratory cycling set at 50 %.
Other: Expiratory trigger (ET)
Varying the cycling criterion according to the percentage of peak inspiratory flow
Experimental: NAVA
NAVA level is adjusted to achieve similar peak inspiratory pressure levels than during PSV.
Device: NAVA
Assisted mechanical ventilation according to the electrical activity of the diaphragm recorded with a 16-FR naso-gastric tube mounted with EMG electrodes
Other Names:
  • Neurally Adjusted Ventilatory Assist

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hôpital Européen Marseille

Investigators

  • Principal Investigator: Jérôme ALLARDET-SERVENT, MD, MSc, Fondation Hôpital Ambroise Paré

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2009

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

September 1, 2019

Study Registration Dates

First Submitted

January 4, 2010

First Submitted That Met QC Criteria

January 4, 2010

First Posted (Estimate)

January 5, 2010

Study Record Updates

Last Update Posted (Actual)

September 6, 2019

Last Update Submitted That Met QC Criteria

September 3, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009-A01099-48

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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