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

NCT ID: NCT01042080

Last Updated: 2019-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2019-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Obstructive Pulmonary Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PSV-ET 25

Pressure support ventilation with expiratory trigger set at 25 %.

Group Type ACTIVE_COMPARATOR

Expiratory trigger (ET)

Intervention Type OTHER

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

PSV-ET 50

Pressure support ventilation with expiratory cycling set at 50 %.

Group Type ACTIVE_COMPARATOR

Expiratory trigger (ET)

Intervention Type OTHER

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

NAVA

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

Group Type EXPERIMENTAL

NAVA

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

NAVA

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 DEVICE

Expiratory trigger (ET)

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

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Neurally Adjusted Ventilatory Assist

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hôpital Européen Marseille

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jerome Allardet-Servent, MD

MD, MSc

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jérôme ALLARDET-SERVENT, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Fondation Hôpital Ambroise Paré

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hopital Paul Desbief

Marseille, , France

Site Status

Fondation Hôpital Ambroise Paré

Marseille, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2009-A01099-48

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.