Comparison of Proportional Assist Ventilation And Neurally Adjusted Ventilator Assist

NCT ID: NCT02056093

Last Updated: 2014-02-05

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-02-28

Brief Summary

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

In spontaneously breathing mechanically ventilated patients, the adequacy between the patient's demand and the level of respiratory support delivered by the ventilator is a major clinical issue. Neurally adjusted ventilator assist (NAVA) and proportional assist ventilation (PAV) have been developed to adapt the level of assistance to the patient's demand. These two modes have been compared to pressure support ventilation (PSV) but have not been compared to each other.

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.

Acute Respiratory Failure

Study Design

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

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

Intubated patients

Intubated patients: The three modes (PSV, PAV, NAVA) will be applied in random order to each mechanically ventilated patient included in the study.

Group Type EXPERIMENTAL

PSV mode

Intervention Type DEVICE

Application of PSV in all patients

PAV mode

Intervention Type DEVICE

Application of PAV mode in all patients

NAVA

Intervention Type DEVICE

Interventions

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

PSV mode

Application of PSV in all patients

Intervention Type DEVICE

PAV mode

Application of PAV mode in all patients

Intervention Type DEVICE

NAVA

Intervention Type DEVICE

Eligibility Criteria

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

Inclusion Criteria

* Intubated patients.
* Mechanical ventilation for a respiratory reason.
* Expected duration of Mechanical ventilation \> 48 hrs.
* Spontaneous breathing.
* Sedations stopped for more than 24 hours.

Exclusion Criteria

* \- Main contra indications to NAVA: gastro-oesophageal surgery in the previous 12 months, oesophageal obstruction, gastro-esophageal bleeding in the previous 30 days, history of esophageal varices, facial trauma or surgery, neuromuscular diseases, individuals with known or suspected phrenic nerve dysfunction.
* Main contra indications to PAV: airway leak, body weight \<25 kg, neuromuscular diseases.
* Hemodynamic instability defined as the current administration of vasopressors or inotropic drugs.
* Severe hypoxemia defined as PaO2/FiO2 ratio \<200.
* Decision to withhold life-sustaining treatment.
* Pregnant women.
* Minors \< 18 years.
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.

Pierre and Marie Curie University

OTHER

Sponsor Role lead

Responsible Party

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

Matthieu SCHMIDT

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Matthieu SCHMIDT, MD

Role: PRINCIPAL_INVESTIGATOR

Association pour le Développement et l'Organisation de la Recherche en Pneumologie

Locations

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

Service de Pneumologie et de Reanimation médicale, Groupe hospitalier Pitie Salpetriere

Paris, Île-de-France Region, France

Site Status RECRUITING

Countries

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

France

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Matthieu SCHMIDT, MD

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

Schmidt M, Kindler F, Cecchini J, Poitou T, Morawiec E, Persichini R, Similowski T, Demoule A. Neurally adjusted ventilatory assist and proportional assist ventilation both improve patient-ventilator interaction. Crit Care. 2015 Feb 25;19(1):56. doi: 10.1186/s13054-015-0763-6.

Reference Type DERIVED
PMID: 25879592 (View on PubMed)

Other Identifiers

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

ADOREP

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

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