Neurally Adjusted Ventilatory Assist and Synchrony in Pat... | NCT01042080

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

NCT01042080

Sponsor

Hôpital Européen Marseille

Status

Completed

Last Update Posted

Sep 6, 2019Actual

Enrollment

16Actual

Phase

Not Applicable

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

NAVA
Expiratory trigger (ET)

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2009Actual

Primary Completion Date

Apr 2011Actual

Completion Date

Sep 2019Actual

First Submitted Date

Jan 4, 2010

First Submission Date that Met QC Criteria

Jan 4, 2010

First Posted Date

Jan 5, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 3, 2019

Last Update Posted Date

Sep 6, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 %).

Detailed Description

Not provided

Conditions Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PSV-ET 25	Active Comparator	Pressure support ventilation with expiratory trigger set at 25 %.	Other: Expiratory trigger (ET)
PSV-ET 50	Active Comparator	Pressure support ventilation with expiratory cycling set at 50 %.	Other: Expiratory trigger (ET)
NAVA	Experimental	NAVA level is adjusted to achieve similar peak inspiratory pressure levels than during PSV.	Device: NAVA

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NAVA	Device	Assisted mechanical ventilation according to the electrical activity of the diaphragm recorded with a 16-FR naso-gastric tube mounted with EMG electrodes	NAVA

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Ineffective inspiratory effort		5 minutes
Dynamic intrinsic PEEP		5 minutes
Arterial blood gases

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jérôme ALLARDET-SERVENT, MD, MSc	Fondation Hôpital Ambroise Paré	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hopital Paul Desbief		Marseille		13002	France
Fondation Hôpital Ambroise Paré

Condition Browse Module

MeSH Terms

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D059725	Interactive Ventilatory Support

Ancestor Terms

ID	Term
D012121	Respiration, Artificial
D058109	Airway Management
D013812	Therapeutics
D012138	Respiratory Therapy

Browse Leaves

Not provided

Browse Branches

Not provided