NCT01042080

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 %).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Dec 2009

Longer than P75 for not_applicable chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 4, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 5, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
8.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

September 6, 2019

Status Verified

September 1, 2019

Enrollment Period

1.3 years

First QC Date

January 4, 2010

Last Update Submit

September 3, 2019

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Mechanical ventilationNeurally adjusted ventilatory assist (NAVA)Acute respiratory failureChronic obstructive pulmonary diseaseWeaningInvasive mechanical ventilationPositive Pressure support Ventilation

Outcome Measures

Primary Outcomes (1)

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

    5 minutes

Secondary Outcomes (4)

  • Ineffective inspiratory effort

    5 minutes

  • Dynamic intrinsic PEEP

    5 minutes

  • Arterial blood gases

    20 minutes

  • Trigger delay

    5 minutes

Study Arms (3)

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

NAVADEVICE

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

Also known as: Neurally Adjusted Ventilatory Assist
NAVA
Expiratory trigger (ET)OTHER

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

PSV-ET 25PSV-ET 50

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hopital Paul Desbief

Marseille, 13002, France

Location

Fondation Hôpital Ambroise Paré

Marseille, 13006, France

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Interactive Ventilatory Support

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Jérôme ALLARDET-SERVENT, MD, MSc

    Fondation Hôpital Ambroise Paré

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, MSc

Study Record Dates

First Submitted

January 4, 2010

First Posted

January 5, 2010

Study Start

December 1, 2009

Primary Completion

April 1, 2011

Study Completion

September 1, 2019

Last Updated

September 6, 2019

Record last verified: 2019-09

Locations

FR(2)