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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
NAVA
Expiratory trigger (ET)
Sponsored by
Hôpital Européen Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Obstructive Pulmonary Disease focused on measuring Mechanical ventilation, Neurally adjusted ventilatory assist (NAVA), Acute respiratory failure, Chronic obstructive pulmonary disease, Weaning, Invasive mechanical ventilation, Positive Pressure support Ventilation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hopital Paul Desbief
  • Fondation Hôpital Ambroise Paré

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Experimental

Arm Label

PSV-ET 25

PSV-ET 50

NAVA

Arm Description

Pressure support ventilation with expiratory trigger set at 25 %.

Pressure support ventilation with expiratory cycling set at 50 %.

NAVA level is adjusted to achieve similar peak inspiratory pressure levels than during PSV.

Outcomes

Primary Outcome Measures

Inspiratory muscle workload as reflected by the diaphragmatic Pressure Time Product (PTPdi)

Secondary Outcome Measures

Ineffective inspiratory effort
Dynamic intrinsic PEEP
Arterial blood gases
Trigger delay

Full Information

First Posted
January 4, 2010
Last Updated
September 3, 2019
Sponsor
Hôpital Européen Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT01042080
Brief Title
Neurally Adjusted Ventilatory Assist and Synchrony in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Acronym
NAVASYNC
Official Title
Effect of Mechanical Ventilation With NAVA and PSV on Inspiratory Muscle Workload and Synchrony in Patients With Chronic Obstructive Pulmonary Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
December 2009 (Actual)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
September 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hôpital Européen Marseille

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 %).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PSV-ET 25
Arm Type
Active Comparator
Arm Description
Pressure support ventilation with expiratory trigger set at 25 %.
Arm Title
PSV-ET 50
Arm Type
Active Comparator
Arm Description
Pressure support ventilation with expiratory cycling set at 50 %.
Arm Title
NAVA
Arm Type
Experimental
Arm Description
NAVA level is adjusted to achieve similar peak inspiratory pressure levels than during PSV.
Intervention Type
Device
Intervention Name(s)
NAVA
Other Intervention Name(s)
Neurally Adjusted Ventilatory Assist
Intervention Description
Assisted mechanical ventilation according to the electrical activity of the diaphragm recorded with a 16-FR naso-gastric tube mounted with EMG electrodes
Intervention Type
Other
Intervention Name(s)
Expiratory trigger (ET)
Intervention Description
Varying the cycling criterion according to the percentage of peak inspiratory flow
Primary Outcome Measure Information:
Title
Inspiratory muscle workload as reflected by the diaphragmatic Pressure Time Product (PTPdi)
Time Frame
5 minutes
Secondary Outcome Measure Information:
Title
Ineffective inspiratory effort
Time Frame
5 minutes
Title
Dynamic intrinsic PEEP
Time Frame
5 minutes
Title
Arterial blood gases
Time Frame
20 minutes
Title
Trigger delay
Time Frame
5 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jérôme ALLARDET-SERVENT, MD, MSc
Organizational Affiliation
Fondation Hôpital Ambroise Paré
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Paul Desbief
City
Marseille
ZIP/Postal Code
13002
Country
France
Facility Name
Fondation Hôpital Ambroise Paré
City
Marseille
ZIP/Postal Code
13006
Country
France

12. IPD Sharing Statement

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

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